IEC 2026-06-18T21:37:03+00:00 Writer LibreOffice 7.3 engines={image=false textcolor=true vector=false text=true} tetml={filename={D:\drim\repository\projects\drim_124_0\metadata\e\f\ef84e4dfb6c8ff7f8dbffeeecabd4457\ef84e4dfb6c8ff7f8dbffeeecabd4457.para.xml} elements={annotations=false bookmarks=false destinations=false fields=false javascripts=false} } granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . CONSOLIDATED C O N S O L I D A T E D VERSION V E R S I O N Medical M e d i c a l device d e v i c e software s o f t w a r e – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s IEC I E C 62304 6 2 3 0 4 Edition E d i t i o n 1.12015-06 1 . 1 2 0 1 5 - 0 6 colour c o l o u r inside i n s i d e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} THIS T H I S PUBLICATION P U B L I C A T I O N IS I S COPYRIGHT C O P Y R I G H T PROTECTED P R O T E C T E D Copyright C o p y r i g h t © © 2015 2 0 1 5 IEC, I E C , Geneva, G e n e v a , Switzerland S w i t z e r l a n d All A l l rights r i g h t s reserved. r e s e r v e d . 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Also A l s o known k n o w n as a s the t h e International I n t e r n a t i o n a l Electrotechnical E l e c t r o t e c h n i c a l Vocabulary V o c a b u l a r y (IEV) ( I E V ) online. o n l i n e . IEC I E C Glossary G l o s s a r y - - std.iec.ch/glossary s t d . i e c . c h / g l o s s a r y More M o r e than t h a n 60 6 0 000 0 0 0 electrotechnical e l e c t r o t e c h n i c a l terminology t e r m i n o l o g y entries e n t r i e s in i n English E n g l i s h and a n d French F r e n c h extracted e x t r a c t e d from f r o m the t h e Terms T e r m s and a n d Definitions D e f i n i t i o n s clause c l a u s e of o f IEC I E C publications p u b l i c a t i o n s issued i s s u e d since s i n c e 2002. 2 0 0 2 . Some S o m e entries e n t r i e s have h a v e been b e e n collected c o l l e c t e d from f r o m earlier e a r l i e r publications p u b l i c a t i o n s of o f IEC I E C TC T C 37, 3 7 , 77, 7 7 , 86 8 6 and a n d CISPR. C I S P R . IEC I E C Customer C u s t o m e r Service S e r v i c e Centre C e n t r e - - webstore.iec.ch/csc w e b s t o r e . i e c . c h / c s c If I f you y o u wish w i s h to t o give g i v e us u s your y o u r feedback f e e d b a c k on o n this t h i s publication p u b l i c a t i o n or o r need n e e d further f u r t h e r assistance, a s s i s t a n c e , please p l e a s e contact c o n t a c t the t h e Customer C u s t o m e r Service S e r v i c e Centre: C e n t r e : csc@iec.ch. c s c @ i e c . c h . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . CONSOLIDATED C O N S O L I D A T E D VERSION V E R S I O N Medical M e d i c a l device d e v i c e software s o f t w a r e – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s INTERNATIONAL I N T E R N A T I O N A L ELECTROTECHNICAL E L E C T R O T E C H N I C A L COMMISSION C O M M I S S I O N IEC I E C 62304 6 2 3 0 4 Edition E d i t i o n 1.1 1 . 1 2015-06 2 0 1 5 - 0 6 colour c o l o u r inside i n s i d e ICS I C S 11.040 1 1 . 0 4 0 ISBN I S B N 978-2-8322-2765-7 9 7 8 - 2 - 8 3 2 2 - 2 7 6 5 - 7 Warning! W a r n i n g ! Make M a k e sure s u r e that t h a t you y o u obtained o b t a i n e d this t h i s publication p u b l i c a t i o n from f r o m an a n authorized a u t h o r i z e d distributor. d i s t r i b u t o r . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . REDLINE R E D L I N E VERSION V E R S I O N Medical M e d i c a l device d e v i c e software s o f t w a r e – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s IEC I E C 62304 6 2 3 0 4 Edition E d i t i o n 1.12015-06 1 . 1 2 0 1 5 - 0 6 colour c o l o u r inside i n s i d e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 2 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 CONTENTS C O N T E N T S FOREWORD......................................................................................................................................... F O R E W O R D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 INTRODUCTION.................................................................................................................................. I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 INTRODUCTION I N T R O D U C T I O N to t o Amendment A m e n d m e n t 1.....................................................................................................8 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 1 Scope.............................................................................................................................................. S c o p e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 1.1 1 . 1 * * Purpose............................................................................................................................. P u r p o s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 1.2 1 . 2 * * Field F i e l d of o f application...........................................................................................................9 a p p l i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.3 1 . 3 Relationship R e l a t i o n s h i p to t o other o t h e r standards........................................................................................9 s t a n d a r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.4 1 . 4 Compliance.......................................................................................................................... C o m p l i a n c e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 2 2 * * Normative N o r m a t i v e references...............................................................................................................10 r e f e r e n c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 3 3 * * Terms T e r m s and a n d definitions...............................................................................................................10 d e f i n i t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 4 4 * * General G e n e r a l requirements...............................................................................................................15 r e q u i r e m e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 4.1 4 . 1 * * Quality Q u a l i t y management m a n a g e m e n t system.........................................................................................15 s y s t e m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 4.2 4 . 2 * * RISK R I S K MANAGEMENT...........................................................................................................16 M A N A G E M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 4.3 4 . 3 * * Software S o f t w a r e safety s a f e t y classification........................................................................................16 c l a s s i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 4.4 4 . 4 * * LEGACY L E G A C Y SOFTWARE...........................................................................................................18 S O F T W A R E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS................................................................................................19 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9 5.1 5 . 1 * * Software S o f t w a r e development d e v e l o p m e n t planning...................................................................................19 p l a n n i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9 5.2 5 . 2 * * Software S o f t w a r e requirements r e q u i r e m e n t s analysis....................................................................................21 a n a l y s i s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 5.3 5 . 3 * * Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design...................................................................................23 d e s i g n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 5.4 5 . 4 * * Software S o f t w a r e detailed d e t a i l e d design...............................................................................................24 d e s i g n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4 5.5 5 . 5 * * SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n ........................................................25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 5.6 5 . 6 * * Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing...............................................................25 t e s t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 5.7 5 . 7 * * SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing..............................................................................................27 t e s t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 7 5.8 5 . 8 * * Software S o f t w a r e release.............................................................................................................28 r e l e a s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS................................................................................................29 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9 6.1 6 . 1 * * Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan..........................................................................29 p l a n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9 6.2 6 . 2 * * Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis...............................................................................30 a n a l y s i s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 6.3 6 . 3 * * Modification M o d i f i c a t i o n implementation..........................................................................................31 i m p l e m e n t a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7 7 * * Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS.....................................................................................31 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7.1 7 . 1 * * Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations........................................31 s i t u a t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures...................................................................................................32 m e a s u r e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures.......................................................................32 m e a s u r e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes..........................................................................33 c h a n g e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 8 8 * * Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS......................................................................33 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 8.1 8 . 1 * * Configuration C o n f i g u r a t i o n identification............................................................................................33 i d e n t i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 8.2 8 . 2 * * Change C h a n g e control...............................................................................................................33 c o n t r o l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 8.3 8 . 3 * * Configuration C o n f i g u r a t i o n status s t a t u s accounting...................................................................................34 a c c o u n t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9 9 * * Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS...................................................................................34 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS...............................................................................................34 R E P O R T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem....................................................................................................35 p r o b l e m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties.....................................................................................................35 p a r t i e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process............................................................................................35 p r o c e s s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9.5 9 . 5 Maintain M a i n t a i n records...............................................................................................................35 r e c o r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends............................................................................................35 t r e n d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution..................................................................................35 r e s o l u t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 3 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents...........................................................................................36 c o n t e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 6 Annex A n n e x A A (informative) ( i n f o r m a t i v e ) Rationale R a t i o n a l e for f o r the t h e requirements r e q u i r e m e n t s of o f this t h i s standard......................................37 s t a n d a r d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7 Annex A n n e x B B (informative) ( i n f o r m a t i v e ) Guidance G u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard...........................................40 s t a n d a r d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 0 Annex A n n e x C C (informative) ( i n f o r m a t i v e ) Relationship R e l a t i o n s h i p to t o other o t h e r standards................................................................58 s t a n d a r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 8 Annex A n n e x D D (informative) ( i n f o r m a t i v e ) Implementation...........................................................................................84 I m p l e m e n t a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4 Bibliography........................................................................................................................................ B i b l i o g r a p h y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 8 6 Index I n d e x of o f defined d e f i n e d terms....................................................................................................................... t e r m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 8 8 Figure F i g u r e 1 1 – – Overview O v e r v i e w of o f software s o f t w a r e development d e v e l o p m e n t PROCESSES P R O C E S S E S and a n d ACTIVITIES....................................7 A C T I V I T I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Figure F i g u r e 2 2 – – Overview O v e r v i e w of o f software s o f t w a r e maintenance m a i n t e n a n c e PROCESSES P R O C E S S E S and a n d ACTIVITIES....................................7 A C T I V I T I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Figure F i g u r e 3 3 – – Assigning A s s i g n i n g software s o f t w a r e safety s a f e t y classification........................................................................16 c l a s s i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 Figure F i g u r e B.2 B . 2 – – Pictorial P i c t o r i a l representation r e p r e s e n t a t i o n of o f the t h e relationship r e l a t i o n s h i p of o f HAZARD, H A Z A R D , sequence s e q u e n c e of o f events, e v e n t s , HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , and a n d HARM H A R M – – from f r o m ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 Annex A n n e x E................................44 E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 Figure F i g u r e B.1 B . 1 – – Example E x a m p l e of o f partitioning p a r t i t i o n i n g of o f SOFTWARE S O F T W A R E ITEMS..............................................................46 I T E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6 Figure F i g u r e C.1 C . 1 – – Relationship R e l a t i o n s h i p of o f key k e y MEDICAL M E D I C A L DEVICE D E V I C E standards s t a n d a r d s to t o IEC I E C 62304.................................59 6 2 3 0 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 9 Figure F i g u r e C.2 C . 2 – – Software S o f t w a r e as a s part p a r t of o f the t h e V-model................................................................................62 V - m o d e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2 Figure F i g u r e C.3 C . 3 – – Application A p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1.............................................................72 6 1 0 1 0 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2 Table T a b l e A.1 A . 1 – – Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y software s o f t w a r e safety s a f e t y class..................................................39 c l a s s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9 Table T a b l e B.1 B . 1 – – Development D e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d in i n ISO/IEC I S O / I E C 12207...............................41 1 2 2 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 Table T a b l e C.1 C . 1 – – Relationship R e l a t i o n s h i p to t o ISO I S O 13485:2003.................................................................................60 1 3 4 8 5 : 2 0 0 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 0 Table T a b l e C.2 C . 2 – – Relationship R e l a t i o n s h i p to t o ISO I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007........................................................................61 2 0 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1 Table T a b l e C.3 C . 3 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-1........................................................................................64 6 0 6 0 1 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4 Table T a b l e C.4 C . 4 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-4 6 0 6 0 1 - 4 ............................................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table T a b l e C.5 C . 5 – – Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207....................................................................................74 1 2 2 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4 Table T a b l e D.1 D . 1 – – Checklist C h e c k l i s t for f o r small s m a l l companies c o m p a n i e s without w i t h o u t a a certified c e r t i f i e d QMS............................................85 Q M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 4 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 INTERNATIONAL I N T E R N A T I O N A L ELECTROTECHNICAL E L E C T R O T E C H N I C A L COMMISSION C O M M I S S I O N MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E – – SOFTWARE S O F T W A R E LIFE L I F E CYCLE C Y C L E PROCESSES P R O C E S S E S FOREWORD F O R E W O R D The T h e International I n t e r n a t i o n a l Electrotechnical E l e c t r o t e c h n i c a l Commission C o m m i s s i o n (IEC) ( I E C ) is i s a a worldwide w o r l d w i d e organization o r g a n i z a t i o n for f o r standardization s t a n d a r d i z a t i o n comprising c o m p r i s i n g all a l l national n a t i o n a l electrotechnical e l e c t r o t e c h n i c a l committees c o m m i t t e e s (IEC ( I E C National N a t i o n a l Committees). C o m m i t t e e s ) . The T h e object o b j e c t of o f IEC I E C is i s to t o promote p r o m o t e international i n t e r n a t i o n a l co-operation c o - o p e r a t i o n on o n all a l l questions q u e s t i o n s concerning c o n c e r n i n g standardization s t a n d a r d i z a t i o n in i n the t h e electrical e l e c t r i c a l and a n d electronic e l e c t r o n i c fields. f i e l d s . To T o this t h i s end e n d and a n d in i n addition a d d i t i o n to t o other o t h e r activities, a c t i v i t i e s , IEC I E C publishes p u b l i s h e s International I n t e r n a t i o n a l Standards, S t a n d a r d s , Technical T e c h n i c a l Specifications, S p e c i f i c a t i o n s , Technical T e c h n i c a l Reports, R e p o r t s , Publicly P u b l i c l y Available A v a i l a b l e Specifications S p e c i f i c a t i o n s (PAS) ( P A S ) and a n d Guides G u i d e s (hereafter ( h e r e a f t e r referred r e f e r r e d to t o as a s “IEC “ I E C Publication(s)”). P u b l i c a t i o n ( s ) ” ) . Their T h e i r preparation p r e p a r a t i o n is i s entrusted e n t r u s t e d to t o technical t e c h n i c a l committees; c o m m i t t e e s ; any a n y IEC I E C National N a t i o n a l Committee C o m m i t t e e interested i n t e r e s t e d in i n the t h e subject s u b j e c t dealt d e a l t with w i t h may m a y participate p a r t i c i p a t e in i n this t h i s preparatory p r e p a r a t o r y work. w o r k . International, I n t e r n a t i o n a l , governmental g o v e r n m e n t a l and a n d non- n o n - governmental g o v e r n m e n t a l organizations o r g a n i z a t i o n s liaising l i a i s i n g with w i t h the t h e IEC I E C also a l s o participate p a r t i c i p a t e in i n this t h i s preparation. p r e p a r a t i o n . IEC I E C collaborates c o l l a b o r a t e s closely c l o s e l y with w i t h the t h e International I n t e r n a t i o n a l Organization O r g a n i z a t i o n for f o r Standardization S t a n d a r d i z a t i o n (ISO) ( I S O ) in i n accordance a c c o r d a n c e with w i t h conditions c o n d i t i o n s determined d e t e r m i n e d by b y agreement a g r e e m e n t between b e t w e e n the t h e two t w o organizations. o r g a n i z a t i o n s . The T h e formal f o r m a l decisions d e c i s i o n s or o r agreements a g r e e m e n t s of o f IEC I E C on o n technical t e c h n i c a l matters m a t t e r s express, e x p r e s s , as a s nearly n e a r l y as a s possible, p o s s i b l e , an a n international i n t e r n a t i o n a l consensus c o n s e n s u s of o f opinion o p i n i o n on o n the t h e relevant r e l e v a n t subjects s u b j e c t s since s i n c e each e a c h technical t e c h n i c a l committee c o m m i t t e e has h a s representation r e p r e s e n t a t i o n from f r o m all a l l interested i n t e r e s t e d IEC I E C National N a t i o n a l Committees. C o m m i t t e e s . IEC I E C Publications P u b l i c a t i o n s have h a v e the t h e form f o r m of o f recommendations r e c o m m e n d a t i o n s for f o r international i n t e r n a t i o n a l use u s e and a n d are a r e accepted a c c e p t e d by b y IEC I E C National N a t i o n a l Committees C o m m i t t e e s in i n that t h a t sense. s e n s e . While W h i l e all a l l reasonable r e a s o n a b l e efforts e f f o r t s are a r e made m a d e to t o ensure e n s u r e that t h a t the t h e technical t e c h n i c a l content c o n t e n t of o f IEC I E C Publications P u b l i c a t i o n s is i s accurate, a c c u r a t e , IEC I E C cannot c a n n o t be b e held h e l d responsible r e s p o n s i b l e for f o r the t h e way w a y in i n which w h i c h they t h e y are a r e used u s e d or o r for f o r any a n y misinterpretation m i s i n t e r p r e t a t i o n by b y any a n y end e n d user. u s e r . In I n order o r d e r to t o promote p r o m o t e international i n t e r n a t i o n a l uniformity, u n i f o r m i t y , IEC I E C National N a t i o n a l Committees C o m m i t t e e s undertake u n d e r t a k e to t o apply a p p l y IEC I E C Publications P u b l i c a t i o n s transparently t r a n s p a r e n t l y to t o the t h e maximum m a x i m u m extent e x t e n t possible p o s s i b l e in i n their t h e i r national n a t i o n a l and a n d regional r e g i o n a l publications. p u b l i c a t i o n s . Any A n y divergence d i v e r g e n c e between b e t w e e n any a n y IEC I E C Publication P u b l i c a t i o n and a n d the t h e corresponding c o r r e s p o n d i n g national n a t i o n a l or o r regional r e g i o n a l publication p u b l i c a t i o n shall s h a l l be b e clearly c l e a r l y indicated i n d i c a t e d in i n the t h e latter. l a t t e r . IEC I E C itself i t s e l f does d o e s not n o t provide p r o v i d e any a n y attestation a t t e s t a t i o n of o f conformity. c o n f o r m i t y . Independent I n d e p e n d e n t certification c e r t i f i c a t i o n bodies b o d i e s provide p r o v i d e conformity c o n f o r m i t y assessment a s s e s s m e n t services s e r v i c e s and, a n d , in i n some s o m e areas, a r e a s , access a c c e s s to t o IEC I E C marks m a r k s of o f conformity. c o n f o r m i t y . IEC I E C is i s not n o t responsible r e s p o n s i b l e for f o r any a n y services s e r v i c e s carried c a r r i e d out o u t by b y independent i n d e p e n d e n t certification c e r t i f i c a t i o n bodies. b o d i e s . All A l l users u s e r s should s h o u l d ensure e n s u r e that t h a t they t h e y have h a v e the t h e latest l a t e s t edition e d i t i o n of o f this t h i s publication. p u b l i c a t i o n . No N o liability l i a b i l i t y shall s h a l l attach a t t a c h to t o IEC I E C or o r its i t s directors, d i r e c t o r s , employees, e m p l o y e e s , servants s e r v a n t s or o r agents a g e n t s including i n c l u d i n g individual i n d i v i d u a l experts e x p e r t s and a n d members m e m b e r s of o f its i t s technical t e c h n i c a l committees c o m m i t t e e s and a n d IEC I E C National N a t i o n a l Committees C o m m i t t e e s for f o r any a n y personal p e r s o n a l injury, i n j u r y , property p r o p e r t y damage d a m a g e or o r other o t h e r damage d a m a g e of o f any a n y nature n a t u r e whatsoever, w h a t s o e v e r , whether w h e t h e r direct d i r e c t or o r indirect, i n d i r e c t , or o r for f o r costs c o s t s (including ( i n c l u d i n g legal l e g a l fees) f e e s ) and a n d expenses e x p e n s e s arising a r i s i n g out o u t of o f the t h e publication, p u b l i c a t i o n , use u s e of, o f , or o r reliance r e l i a n c e upon, u p o n , this t h i s IEC I E C Publication P u b l i c a t i o n or o r any a n y other o t h e r IEC I E C Publications. P u b l i c a t i o n s . Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e Normative N o r m a t i v e references r e f e r e n c e s cited c i t e d in i n this t h i s publication. p u b l i c a t i o n . Use U s e of o f the t h e referenced r e f e r e n c e d publications p u b l i c a t i o n s is i s indispensable i n d i s p e n s a b l e for f o r the t h e correct c o r r e c t application a p p l i c a t i o n of o f this t h i s publication. p u b l i c a t i o n . Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e possibility p o s s i b i l i t y that t h a t some s o m e of o f the t h e elements e l e m e n t s of o f this t h i s IEC I E C Publication P u b l i c a t i o n may m a y be b e the t h e subject s u b j e c t of o f patent p a t e n t rights. r i g h t s . IEC I E C shall s h a l l not n o t be b e held h e l d responsible r e s p o n s i b l e for f o r identifying i d e n t i f y i n g any a n y or o r all a l l such s u c h patent p a t e n t rights. r i g h t s . DISCLAIMER D I S C L A I M E R This T h i s Consolidated C o n s o l i d a t e d version v e r s i o n is i s not n o t an a n official o f f i c i a l IEC I E C Standard S t a n d a r d and a n d has h a s been b e e n prepared p r e p a r e d for f o r user u s e r convenience. c o n v e n i e n c e . Only O n l y the t h e current c u r r e n t versions v e r s i o n s of o f the t h e standard s t a n d a r d and a n d its i t s amendment(s) a m e n d m e n t ( s ) are a r e to t o be b e considered c o n s i d e r e d the t h e official o f f i c i a l documents. d o c u m e n t s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . This T h i s Consolidated C o n s o l i d a t e d version v e r s i o n of o f IEC I E C 62304 6 2 3 0 4 bears b e a r s the t h e edition e d i t i o n number n u m b e r 1.1. 1 . 1 . It I t consists c o n s i s t s of o f the t h e first f i r s t edition e d i t i o n (2006-05) ( 2 0 0 6 - 0 5 ) [documents [ d o c u m e n t s 62A/523/FDIS 6 2 A / 5 2 3 / F D I S and a n d 62A/528/RVD] 6 2 A / 5 2 8 / R V D ] and a n d its i t s amendment a m e n d m e n t 1 1 (2015-06) ( 2 0 1 5 - 0 6 ) [documents [ d o c u m e n t s 62A/1007/FDIS 6 2 A / 1 0 0 7 / F D I S and a n d 62A/1014/RVD]. 6 2 A / 1 0 1 4 / R V D ] . The T h e technical t e c h n i c a l content c o n t e n t is i s identical i d e n t i c a l to t o the t h e base b a s e edition e d i t i o n and a n d its i t s amendment. a m e n d m e n t . In I n this t h i s Redline R e d l i n e version, v e r s i o n , a a vertical v e r t i c a l line l i n e in i n the t h e margin m a r g i n shows s h o w s where w h e r e the t h e technical t e c h n i c a l content c o n t e n t is i s modified m o d i f i e d by b y amendment a m e n d m e n t 1. 1 . Additions A d d i t i o n s and a n d deletions d e l e t i o n s are a r e displayed d i s p l a y e d in i n red, r e d , with w i t h deletions d e l e t i o n s being b e i n g struck s t r u c k through. t h r o u g h . A A separate s e p a r a t e Final F i n a l version v e r s i o n with w i t h all a l l changes c h a n g e s accepted a c c e p t e d is i s available a v a i l a b l e in i n this t h i s publication. p u b l i c a t i o n . International I n t e r n a t i o n a l Standard S t a n d a r d IEC I E C 62304 6 2 3 0 4 has h a s been b e e n prepared p r e p a r e d by b y a a joint j o i n t working w o r k i n g group g r o u p of o f subcommittee s u b c o m m i t t e e 62A: 6 2 A : Common C o m m o n aspects a s p e c t s of o f electrical e l e c t r i c a l equipment e q u i p m e n t used u s e d in i n medical m e d i c a l practice, p r a c t i c e , of o f IEC I E C technical t e c h n i c a l granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 5 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 committee c o m m i t t e e 62: 6 2 : Electrical E l e c t r i c a l equipment e q u i p m e n t in i n medical m e d i c a l practice p r a c t i c e and a n d ISO I S O Technical T e c h n i c a l Committee C o m m i t t e e 210, 2 1 0 , Quality Q u a l i t y management m a n a g e m e n t and a n d corresponding c o r r e s p o n d i n g general g e n e r a l aspects a s p e c t s for f o r MEDICAL M E D I C A L DEVICES. D E V I C E S . Table T a b l e C.5 C . 5 was w a s prepared p r e p a r e d by b y ISO/IEC I S O / I E C JTC J T C 1/SC 1 / S C 7, 7 , Software S o f t w a r e and a n d system s y s t e m engineering. e n g i n e e r i n g . It I t is i s published p u b l i s h e d as a s a a dual d u a l logo l o g o standard. s t a n d a r d . This T h i s publication p u b l i c a t i o n has h a s been b e e n drafted d r a f t e d in i n accordance a c c o r d a n c e with w i t h the t h e ISO/IEC I S O / I E C Directives, D i r e c t i v e s , Part P a r t 2. 2 . In I n this t h i s standard s t a n d a r d the t h e following f o l l o w i n g print p r i n t types t y p e s are a r e used: u s e d : requirements r e q u i r e m e n t s and a n d definitions: d e f i n i t i o n s : in i n roman r o m a n type; t y p e ; informative i n f o r m a t i v e material m a t e r i a l appearing a p p e a r i n g outside o u t s i d e of o f tables, t a b l e s , such s u c h as a s notes, n o t e s , examples e x a m p l e s and a n d references: r e f e r e n c e s : in i n smaller s m a l l e r type. t y p e . Normative N o r m a t i v e text t e x t of o f tables t a b l e s is i s also a l s o in i n a a smaller s m a l l e r type; t y p e ; terms t e r m s used u s e d throughout t h r o u g h o u t this t h i s standard s t a n d a r d that t h a t have h a v e been b e e n defined d e f i n e d in i n Clause C l a u s e 3 3 and a n d also a l s o given g i v e n in i n the t h e index: i n d e x : in i n small s m a l l capitals. c a p i t a l s . An A n asterisk a s t e r i s k (*) ( * ) as a s the t h e first f i r s t character c h a r a c t e r of o f a a title t i t l e or o r at a t the t h e beginning b e g i n n i n g of o f a a paragraph p a r a g r a p h indicates i n d i c a t e s that t h a t there t h e r e is i s guidance g u i d a n c e related r e l a t e d to t o that t h a t item i t e m in i n Annex A n n e x B. B . The T h e committee c o m m i t t e e has h a s decided d e c i d e d that t h a t the t h e contents c o n t e n t s of o f the t h e base b a s e publication p u b l i c a t i o n and a n d its i t s amendment a m e n d m e n t will w i l l remain r e m a i n unchanged u n c h a n g e d until u n t i l the t h e stability s t a b i l i t y date d a t e indicated i n d i c a t e d on o n the t h e IEC I E C web w e b site s i t e under u n d e r "http://webstore.iec.ch" " h t t p : / / w e b s t o r e . i e c . c h " in i n the t h e data d a t a related r e l a t e d to t o the t h e specific s p e c i f i c publication. p u b l i c a t i o n . At A t this t h i s date, d a t e , the t h e publication p u b l i c a t i o n will w i l l be b e � reconfirmed, r e c o n f i r m e d , � withdrawn, w i t h d r a w n , � replaced r e p l a c e d by b y a a revised r e v i s e d edition, e d i t i o n , or o r � amended. a m e n d e d . NOTE N O T E The T h e attention a t t e n t i o n of o f National N a t i o n a l Committees C o m m i t t e e s is i s drawn d r a w n to t o the t h e fact f a c t that t h a t equipment e q u i p m e n t MANUFACTURERS M A N U F A C T U R E R S and a n d testing t e s t i n g organizations o r g a n i z a t i o n s may m a y need n e e d a a transitional t r a n s i t i o n a l period p e r i o d following f o l l o w i n g publication p u b l i c a t i o n of o f a a new, n e w , amended a m e n d e d or o r revised r e v i s e d IEC I E C or o r ISO I S O publication p u b l i c a t i o n in i n which w h i c h to t o make m a k e products p r o d u c t s in i n accordance a c c o r d a n c e with w i t h the t h e new n e w requirements r e q u i r e m e n t s and a n d to t o equip e q u i p themselves t h e m s e l v e s for f o r conducting c o n d u c t i n g new n e w or o r revised r e v i s e d tests. t e s t s . It I t is i s the t h e recommendation r e c o m m e n d a t i o n of o f the t h e committee c o m m i t t e e that t h a t the t h e content c o n t e n t of o f this t h i s publication p u b l i c a t i o n be b e adopted a d o p t e d for f o r mandatory m a n d a t o r y implementation i m p l e m e n t a t i o n nationally n a t i o n a l l y not n o t earlier e a r l i e r than t h a n 3 3 years y e a r s from f r o m the t h e date d a t e of o f publication. p u b l i c a t i o n . IMPORTANT I M P O R T A N T – – The T h e 'colour ' c o l o u r inside' i n s i d e ' logo l o g o on o n the t h e cover c o v e r page p a g e of o f this t h i s publication p u b l i c a t i o n indicates i n d i c a t e s that t h a t it i t contains c o n t a i n s colours c o l o u r s which w h i c h are a r e considered c o n s i d e r e d to t o be b e useful u s e f u l for f o r the t h e correct c o r r e c t understanding u n d e r s t a n d i n g of o f its i t s contents. c o n t e n t s . Users U s e r s should s h o u l d therefore t h e r e f o r e print p r i n t this t h i s document d o c u m e n t using u s i n g a a colour c o l o u r printer. p r i n t e r . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 6 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 INTRODUCTION I N T R O D U C T I O N Software S o f t w a r e is i s often o f t e n an a n integral i n t e g r a l part p a r t of o f MEDICAL M E D I C A L DEVICE D E V I C E technology. t e c h n o l o g y . Establishing E s t a b l i s h i n g the t h e SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s of o f a a MEDICAL M E D I C A L DEVICE D E V I C E containing c o n t a i n i n g software s o f t w a r e requires r e q u i r e s knowledge k n o w l e d g e of o f what w h a t the t h e software s o f t w a r e is i s intended i n t e n d e d to t o do d o and a n d demonstration d e m o n s t r a t i o n that t h a t the t h e use u s e of o f the t h e software s o f t w a r e fulfils f u l f i l s those t h o s e intentions i n t e n t i o n s without w i t h o u t causing c a u s i n g any a n y unacceptable u n a c c e p t a b l e RISKS. R I S K S . This T h i s standard s t a n d a r d provides p r o v i d e s a a framework f r a m e w o r k of o f life l i f e cycle c y c l e PROCESSES P R O C E S S E S with w i t h ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S necessary n e c e s s a r y for f o r the t h e safe s a f e design d e s i g n and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s standard s t a n d a r d provides p r o v i d e s requirements r e q u i r e m e n t s for f o r each e a c h life l i f e cycle c y c l e PROCESS. P R O C E S S . Each E a c h life l i f e cycle c y c l e PROCESS P R O C E S S is i s further f u r t h e r divided d i v i d e d into i n t o consists c o n s i s t s of o f a a set s e t of o f ACTIVITIES, A C T I V I T I E S , with w i t h most m o s t ACTIVITIES A C T I V I T I E S further f u r t h e r divided d i v i d e d into i n t o consisting c o n s i s t i n g of o f a a set s e t of o f TASKS. T A S K S . As A s a a basic b a s i c foundation f o u n d a t i o n it i t is i s assumed a s s u m e d that t h a t MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s developed d e v e l o p e d and a n d maintained m a i n t a i n e d within w i t h i n a a quality q u a l i t y management m a n a g e m e n t system s y s t e m (see ( s e e 4.1) 4 . 1 ) and a n d a a RISK R I S K MANAGEMENT M A N A G E M E N T system s y s t e m (see ( s e e 4.2). 4 . 2 ) . The T h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S is i s already a l r e a d y very v e r y well w e l l addressed a d d r e s s e d by b y the t h e International I n t e r n a t i o n a l Standard S t a n d a r d ISO I S O 14971. 1 4 9 7 1 . Therefore T h e r e f o r e IEC I E C 62304 6 2 3 0 4 makes m a k e s use u s e of o f this t h i s advantage a d v a n t a g e simply s i m p l y by b y a a normative n o r m a t i v e reference r e f e r e n c e to t o ISO I S O 14971. 1 4 9 7 1 . Some S o m e minor m i n o r additional a d d i t i o n a l RISK R I S K MANAGEMENT M A N A G E M E N T requirements r e q u i r e m e n t s are a r e needed n e e d e d for f o r software, s o f t w a r e , especially e s p e c i a l l y in i n the t h e area a r e a of o f identification i d e n t i f i c a t i o n of o f contributing c o n t r i b u t i n g software s o f t w a r e factors f a c t o r s related r e l a t e d to t o HAZARDS. H A Z A R D S . These T h e s e requirements r e q u i r e m e n t s are a r e summarized s u m m a r i z e d and a n d captured c a p t u r e d in i n Clause C l a u s e 7 7 as a s the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . Whether W h e t h e r software s o f t w a r e is i s a a contributing c o n t r i b u t i n g factor f a c t o r to t o a a HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N is i s determined d e t e r m i n e d during d u r i n g the t h e HAZARD H A Z A R D identification i d e n t i f i c a t i o n ACTIVITY A C T I V I T Y of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . H H AZARDS A Z A R D S HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t could c o u l d be b e indirectly i n d i r e c t l y caused c a u s e d by b y software s o f t w a r e (for ( f o r example, e x a m p l e , by b y providing p r o v i d i n g misleading m i s l e a d i n g information i n f o r m a t i o n that t h a t could c o u l d cause c a u s e inappropriate i n a p p r o p r i a t e treatment t r e a t m e n t to t o be b e administered) a d m i n i s t e r e d ) need n e e d to t o be b e considered c o n s i d e r e d when w h e n determining d e t e r m i n i n g whether w h e t h e r software s o f t w a r e is i s a a contributing c o n t r i b u t i n g factor. f a c t o r . The T h e decision d e c i s i o n to t o use u s e software s o f t w a r e to t o control c o n t r o l RISK R I S K is i s made m a d e during d u r i n g the t h e RISK R I S K CONTROL C O N T R O L ACTIVITY A C T I V I T Y of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S required r e q u i r e d in i n this t h i s standard s t a n d a r d has h a s to t o be b e embedded e m b e d d e d in i n the t h e device d e v i c e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S according a c c o r d i n g to t o ISO I S O 14971. 1 4 9 7 1 . The T h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S consists c o n s i s t s of o f a a number n u m b e r of o f ACTIVITIES. A C T I V I T I E S . These T h e s e ACTIVITIES A C T I V I T I E S are a r e shown s h o w n in i n Figure F i g u r e 1 1 and a n d described d e s c r i b e d in i n Clause C l a u s e 5. 5 . Because B e c a u s e many m a n y incidents i n c i d e n t s in i n the t h e field f i e l d are a r e related r e l a t e d to t o service s e r v i c e or o r maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SYSTEMS S Y S T E M S including i n c l u d i n g inappropriate i n a p p r o p r i a t e software s o f t w a r e updates u p d a t e s and a n d upgrades, u p g r a d e s , the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s considered c o n s i d e r e d to t o be b e as a s important i m p o r t a n t as a s the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS. P R O C E S S . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s very v e r y similar s i m i l a r to t o the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS. P R O C E S S . It I t is i s shown s h o w n in i n Figure F i g u r e 2 2 and a n d described d e s c r i b e d in i n Clause C l a u s e 6. 6 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 7 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Activities A c t i v i t i e s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard s t a n d a r d Customer C u s t o m e r needs n e e d s Customer C u s t o m e r needs n e e d s satisfied s a t i s f i e d SYSTEM S Y S T E M development d e v e l o p m e n t ACTIVITIES A C T I V I T I E S (including ( i n c l u d i n g RISK R I S K MANAGEMENT) M A N A G E M E N T ) 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T 5.1 5 . 1 5.2 5 . 2 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.4 5 . 4 5.5 5 . 5 5.6 5 . 6 Software S o f t w a r e Software S o f t w a r e detailed d e t a i l e d UNIT U N I T design d e s i g n implementation i m p l e m e n t a t i o n Software S o f t w a r e and a n d VERIFICATION V E R I F I C A T I O N integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 Software S o f t w a r e SYSTEM S Y S T E M testing t e s t i n g 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n IEC I E C 722/06 7 2 2 / 0 6 Figure F i g u r e 1 1 – – Overview O v e r v i e w of o f software s o f t w a r e development d e v e l o p m e n t PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S Maintenance M a i n t e n a n c e request r e q u e s t Activities A c t i v i t i e s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard s t a n d a r d Request R e q u e s t satisfied s a t i s f i e d System S y s t e m maintenance m a i n t e n a n c e ACTIVITIES A C T I V I T I E S (including ( i n c l u d i n g RISK R I S K MANAGEMENT) M A N A G E M E N T ) 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T 5.3 5 . 3 6.1 6 . 1 6.2 6 . 2 Software S o f t w a r e Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysisARCHITECTURAL a n a l y s i s A R C H I T E C T U R A L plan p l a n design d e s i g n 5.4 5 . 4 5.5 5 . 5 5.6 5 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n Software S o f t w a r e UNIT U N I T Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 Software S o f t w a r e SYSTEM S Y S T E M implementation i m p l e m e n t a t i o n and a n d VERIFICATION V E R I F I C A T I O N testing t e s t i n g 5.8 5 . 8 Software S o f t w a r e release r e l e a s e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n IEC I E C 723/06 7 2 3 / 0 6 Figure F i g u r e 2 2 – – Overview O v e r v i e w of o f software s o f t w a r e maintenance m a i n t e n a n c e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S This T h i s standard s t a n d a r d identifies i d e n t i f i e s two t w o additional a d d i t i o n a l PROCESSES P R O C E S S E S considered c o n s i d e r e d essential e s s e n t i a l for f o r developing d e v e l o p i n g safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . They T h e y are a r e the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) and a n d the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S (Clause ( C l a u s e 9). 9 ) . Amendment A m e n d m e n t 1 1 updates u p d a t e s the t h e standard s t a n d a r d to t o add a d d requirements r e q u i r e m e n t s to t o deal d e a l with w i t h LEGACY L E G A C Y SOFTWARE, S O F T W A R E , where w h e r e the t h e software s o f t w a r e design d e s i g n is i s prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version, v e r s i o n , to t o assist a s s i s t manufacturers m a n u f a c t u r e r s who w h o must m u s t show s h o w compliance c o m p l i a n c e to t o the t h e standard s t a n d a r d to t o meet m e e t European E u r o p e a n Directives. D i r e c t i v e s . Software S o f t w a r e safety s a f e t y granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 8 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 classification c l a s s i f i c a t i o n changes c h a n g e s include i n c l u d e clarification c l a r i f i c a t i o n of o f requirements r e q u i r e m e n t s and a n d updating u p d a t i n g of o f the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o include i n c l u d e a a risk-based r i s k - b a s e d approach. a p p r o a c h . This T h i s standard s t a n d a r d does d o e s not n o t specify s p e c i f y an a n organizational o r g a n i z a t i o n a l structure s t r u c t u r e for f o r the t h e MANUFACTURER M A N U F A C T U R E R or o r which w h i c h part p a r t of o f the t h e organization o r g a n i z a t i o n is i s to t o perform p e r f o r m which w h i c h PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , or o r TASK. T A S K . This T h i s standard s t a n d a r d requires r e q u i r e s only o n l y that t h a t the t h e PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , or o r TASK T A S K be b e completed c o m p l e t e d to t o establish e s t a b l i s h compliance c o m p l i a n c e with w i t h this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t prescribe p r e s c r i b e the t h e name, n a m e , format, f o r m a t , or o r explicit e x p l i c i t content c o n t e n t of o f the t h e documentation d o c u m e n t a t i o n to t o be b e produced. p r o d u c e d . This T h i s standard s t a n d a r d requires r e q u i r e s documentation d o c u m e n t a t i o n of o f TASKS, T A S K S , but b u t the t h e decision d e c i s i o n of o f how h o w to t o package p a c k a g e this t h i s documentation d o c u m e n t a t i o n is i s left l e f t to t o the t h e user u s e r of o f the t h e standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t prescribe p r e s c r i b e a a specific s p e c i f i c life l i f e cycle c y c l e model. m o d e l . The T h e users u s e r s of o f this t h i s standard s t a n d a r d are a r e responsible r e s p o n s i b l e for f o r selecting s e l e c t i n g a a life l i f e cycle c y c l e model m o d e l for f o r the t h e software s o f t w a r e project p r o j e c t and a n d for f o r mapping m a p p i n g the t h e PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S in i n this t h i s standard s t a n d a r d onto o n t o that t h a t model. m o d e l . Annex A n n e x A A provides p r o v i d e s rationale r a t i o n a l e for f o r the t h e clauses c l a u s e s of o f this t h i s standard. s t a n d a r d . Annex A n n e x B B provides p r o v i d e s guidance g u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard. s t a n d a r d . For F o r the t h e purposes p u r p o s e s of o f this t h i s standard: s t a n d a r d : “shall” “ s h a l l ” means m e a n s that t h a t compliance c o m p l i a n c e with w i t h a a requirement r e q u i r e m e n t is i s mandatory m a n d a t o r y for f o r compliance c o m p l i a n c e with w i t h this t h i s standard; s t a n d a r d ; “should” “ s h o u l d ” means m e a n s that t h a t compliance c o m p l i a n c e with w i t h a a requirement r e q u i r e m e n t is i s recommended r e c o m m e n d e d but b u t is i s not n o t mandatory m a n d a t o r y for f o r compliance c o m p l i a n c e with w i t h this t h i s standard; s t a n d a r d ; “may” “ m a y ” is i s used u s e d to t o describe d e s c r i b e a a permissible p e r m i s s i b l e way w a y to t o achieve a c h i e v e compliance c o m p l i a n c e with w i t h a a requirement; r e q u i r e m e n t ; “establish” “ e s t a b l i s h ” means m e a n s to t o define, d e f i n e , document, d o c u m e n t , and a n d implement; i m p l e m e n t ; and a n d � where w h e r e this t h i s standard s t a n d a r d uses u s e s the t h e term t e r m “as “ a s appropriate” a p p r o p r i a t e ” in i n conjunction c o n j u n c t i o n with w i t h a a required r e q u i r e d PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , TASK T A S K or o r output, o u t p u t , the t h e intention i n t e n t i o n is i s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , TASK T A S K or o r output o u t p u t unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R can c a n document d o c u m e n t a a justification j u s t i f i c a t i o n for f o r not n o t so s o doing. d o i n g . INTRODUCTION I N T R O D U C T I O N to t o Amendment A m e n d m e n t 1 1 The T h e first f i r s t edition e d i t i o n of o f IEC I E C 62304 6 2 3 0 4 was w a s published p u b l i s h e d in i n 2006. 2 0 0 6 . This T h i s amendment a m e n d m e n t is i s intended i n t e n d e d to t o add a d d requirements r e q u i r e m e n t s to t o deal d e a l with w i t h LEGACY L E G A C Y SOFTWARE, S O F T W A R E , where w h e r e the t h e software s o f t w a r e design d e s i g n is i s prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version, v e r s i o n , to t o assist a s s i s t manufacturers m a n u f a c t u r e r s who w h o must m u s t show s h o w compliance c o m p l i a n c e to t o the t h e standard s t a n d a r d to t o meet m e e t European E u r o p e a n Directives. D i r e c t i v e s . Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n changes c h a n g e s needed n e e d e d for f o r this t h i s amendment a m e n d m e n t include i n c l u d e clarification c l a r i f i c a t i o n of o f requirements r e q u i r e m e n t s and a n d updating u p d a t i n g of o f the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o include i n c l u d e a a risk-based r i s k - b a s e d approach. a p p r o a c h . Work W o r k is i s continuing c o n t i n u i n g in i n parallel p a r a l l e l to t o develop d e v e l o p the t h e second s e c o n d edition e d i t i o n of o f IEC I E C 62304. 6 2 3 0 4 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 9 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E – – SOFTWARE S O F T W A R E LIFE L I F E CYCLE C Y C L E PROCESSES P R O C E S S E S 1 1 Scope S c o p e 1.1 1 . 1 * * Purpose P u r p o s e This T h i s standard s t a n d a r d defines d e f i n e s the t h e life l i f e cycle c y c l e requirements r e q u i r e m e n t s for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . The T h e set s e t of o f PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S described d e s c r i b e d in i n this t h i s standard s t a n d a r d establishes e s t a b l i s h e s a a common c o m m o n framework f r a m e w o r k for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E life l i f e cycle c y c l e PROCESSES. P R O C E S S E S . 1.2 1 . 2 * * Field F i e l d of o f application a p p l i c a t i o n This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E when w h e n software s o f t w a r e is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE D E V I C E or o r when w h e n software s o f t w a r e is i s an a n embedded e m b e d d e d or o r integral i n t e g r a l part p a r t of o f the t h e final f i n a l MEDICAL M E D I C A L DEVICE. D E V I C E . NOTE N O T E 1 1 This T h i s standard s t a n d a r d can c a n be b e used u s e d in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f software s o f t w a r e that t h a t is i s itself i t s e l f a a medical m e d i c a l device. d e v i c e . However, H o w e v e r , additional a d d i t i o n a l development d e v e l o p m e n t activities a c t i v i t i e s are a r e needed n e e d e d at a t the t h e system s y s t e m level l e v e l before b e f o r e this t h i s type t y p e of o f software s o f t w a r e can c a n be b e placed p l a c e d into i n t o service. s e r v i c e . These T h e s e system s y s t e m activities a c t i v i t i e s are a r e not n o t covered c o v e r e d by b y this t h i s standard, s t a n d a r d , but b u t can c a n be b e found f o u n d in i n IEC I E C 82304-1 8 2 3 0 4 - 1 1 1 [22]. [ 2 2 ] . This T h i s standard s t a n d a r d describes d e s c r i b e s PROCESSES P R O C E S S E S that t h a t are a r e intended i n t e n d e d to t o be b e applied a p p l i e d to t o software s o f t w a r e which w h i c h executes e x e c u t e s on o n a a processor p r o c e s s o r or o r which w h i c h is i s executed e x e c u t e d by b y other o t h e r software s o f t w a r e (for ( f o r example e x a m p l e an a n interpreter) i n t e r p r e t e r ) which w h i c h executes e x e c u t e s on o n a a processor. p r o c e s s o r . This T h i s standard s t a n d a r d applies a p p l i e s regardless r e g a r d l e s s of o f the t h e persistent p e r s i s t e n t storage s t o r a g e device(s) d e v i c e ( s ) used u s e d to t o store s t o r e the t h e software s o f t w a r e (for ( f o r example: e x a m p l e : hard h a r d disk, d i s k , optical o p t i c a l disk, d i s k , permanent p e r m a n e n t or o r flash f l a s h memory). m e m o r y ) . This T h i s standard s t a n d a r d applies a p p l i e s regardless r e g a r d l e s s of o f the t h e method m e t h o d of o f delivery d e l i v e r y of o f the t h e software s o f t w a r e (for ( f o r example: e x a m p l e : transmission t r a n s m i s s i o n by b y network n e t w o r k or o r email, e m a i l , optical o p t i c a l disk, d i s k , flash f l a s h memory m e m o r y or o r EEPROM). E E P R O M ) . The T h e method m e t h o d of o f software s o f t w a r e delivery d e l i v e r y itself i t s e l f is i s not n o t considered c o n s i d e r e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r validation v a l i d a t i o n and a n d final f i n a l release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE, D E V I C E , even e v e n when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E consists c o n s i s t s entirely e n t i r e l y of o f software. s o f t w a r e . NOTE N O T E 2 2 If I f a a medical m e d i c a l device d e v i c e incorporates i n c o r p o r a t e s embedded e m b e d d e d software s o f t w a r e intended i n t e n d e d to t o be b e executed e x e c u t e d on o n a a processor, p r o c e s s o r , the t h e requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d apply a p p l y to t o the t h e software, s o f t w a r e , including i n c l u d i n g the t h e requirements r e q u i r e m e n t s concerning c o n c e r n i n g software s o f t w a r e of o f unknown u n k n o w n provenance p r o v e n a n c e (see ( s e e 8.1.2). 8 . 1 . 2 ) . NOTE N O T E 3 3 Validation V a l i d a t i o n and a n d other o t h e r development d e v e l o p m e n t activities a c t i v i t i e s are a r e needed n e e d e d at a t the t h e system s y s t e m level l e v e l before b e f o r e the t h e software s o f t w a r e and a n d medical m e d i c a l device d e v i c e can c a n be b e placed p l a c e d into i n t o service. s e r v i c e . These T h e s e system s y s t e m activities a c t i v i t i e s are a r e not n o t covered c o v e r e d by b y this t h i s standard, s t a n d a r d , but b u t can c a n be b e found f o u n d in i n related r e l a t e d product p r o d u c t standards s t a n d a r d s (e.g., ( e . g . , IEC I E C 60601-1, 6 0 6 0 1 - 1 , IEC I E C 82304-1, 8 2 3 0 4 - 1 , etc.). e t c . ) . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 1.3 1 . 3 Relationship R e l a t i o n s h i p to t o other o t h e r standards s t a n d a r d s This T h i s MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E life l i f e cycle c y c l e standard s t a n d a r d is i s to t o be b e used u s e d together t o g e t h e r with w i t h other o t h e r appropriate a p p r o p r i a t e standards s t a n d a r d s when w h e n developing d e v e l o p i n g a a MEDICAL M E D I C A L DEVICE. D E V I C E . Annex A n n e x C C shows s h o w s the t h e relationship r e l a t i o n s h i p between b e t w e e n this t h i s standard s t a n d a r d and a n d other o t h e r relevant r e l e v a n t standards. s t a n d a r d s . 1.4 1 . 4 Compliance C o m p l i a n c e Compliance C o m p l i a n c e with w i t h this t h i s standard s t a n d a r d is i s defined d e f i n e d as a s implementing i m p l e m e n t i n g all a l l of o f the t h e PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S identified i d e n t i f i e d in i n this t h i s standard s t a n d a r d in i n accordance a c c o r d a n c e with w i t h the t h e software s o f t w a r e safety s a f e t y class. c l a s s . 1 1 In I n preparation. p r e p a r a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 10 1 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E The T h e software s o f t w a r e safety s a f e t y classes c l a s s e s assigned a s s i g n e d to t o each e a c h requirement r e q u i r e m e n t are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t following f o l l o w i n g the t h e requirement. r e q u i r e m e n t . Compliance C o m p l i a n c e is i s determined d e t e r m i n e d by b y inspection i n s p e c t i o n of o f all a l l documentation d o c u m e n t a t i o n required r e q u i r e d by b y this t h i s standard s t a n d a r d including i n c l u d i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE, F I L E , and a n d assessment a s s e s s m e n t of o f the t h e PROCESSES, P R O C E S S E S , ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S required r e q u i r e d for f o r the t h e software s o f t w a r e safety s a f e t y class. c l a s s . See S e e Annex A n n e x D. D . NOTE N O T E 1 1 This T h i s assessment a s s e s s m e n t could c o u l d be b e carried c a r r i e d out o u t by b y internal i n t e r n a l or o r external e x t e r n a l audit. a u d i t . NOTE N O T E 2 2 Although A l t h o u g h the t h e specified s p e c i f i e d PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S are a r e performed, p e r f o r m e d , flexibility f l e x i b i l i t y exists e x i s t s in i n the t h e methods m e t h o d s of o f implementing i m p l e m e n t i n g these t h e s e PROCESSES P R O C E S S E S and a n d performing p e r f o r m i n g these t h e s e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . NOTE N O T E 3 3 Where W h e r e any a n y requirements r e q u i r e m e n t s contain c o n t a i n “as “ a s appropriate” a p p r o p r i a t e ” and a n d were w e r e not n o t performed, p e r f o r m e d , documentation d o c u m e n t a t i o n for f o r the t h e justification j u s t i f i c a t i o n is i s necessary n e c e s s a r y for f o r this t h i s assessment. a s s e s s m e n t . NOTE N O T E 4 4 The T h e term t e r m “conformance” “ c o n f o r m a n c e ” is i s used u s e d in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 where w h e r e the t h e term t e r m “compliance” “ c o m p l i a n c e ” is i s used u s e d in i n this t h i s standard. s t a n d a r d . NOTE N O T E 5 5 For F o r compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E see s e e 4.4. 4 . 4 . 2 2 * * Normative N o r m a t i v e references r e f e r e n c e s The T h e following f o l l o w i n g referenced r e f e r e n c e d documents d o c u m e n t s are a r e indispensable i n d i s p e n s a b l e for f o r the t h e application a p p l i c a t i o n of o f this t h i s document. d o c u m e n t . For F o r dated d a t e d references, r e f e r e n c e s , only o n l y the t h e edition e d i t i o n cited c i t e d applies. a p p l i e s . For F o r undated u n d a t e d references, r e f e r e n c e s , the t h e latest l a t e s t edition e d i t i o n of o f the t h e referenced r e f e r e n c e d document d o c u m e n t (including ( i n c l u d i n g any a n y amendments) a m e n d m e n t s ) applies. a p p l i e s . ISO I S O 14971, 1 4 9 7 1 , Medical M e d i c a l devices d e v i c e s – – Application A p p l i c a t i o n of o f risk r i s k management m a n a g e m e n t to t o medical m e d i c a l devices. d e v i c e s . 3 3 * * Terms T e r m s and a n d definitions d e f i n i t i o n s For F o r the t h e purposes p u r p o s e s of o f this t h i s document, d o c u m e n t , the t h e following f o l l o w i n g terms t e r m s and a n d definitions d e f i n i t i o n s apply. a p p l y . 3.1 3 . 1 ACTIVITY A C T I V I T Y a a set s e t of o f one o n e or o r more m o r e interrelated i n t e r r e l a t e d or o r interacting i n t e r a c t i n g TASKS T A S K S 3.2 3 . 2 ANOMALY A N O M A L Y any a n y condition c o n d i t i o n that t h a t deviates d e v i a t e s from f r o m the t h e expected e x p e c t e d based b a s e d on o n requirements r e q u i r e m e n t s specifications, s p e c i f i c a t i o n s , design d e s i g n documents, d o c u m e n t s , standards, s t a n d a r d s , etc. e t c . or o r from f r o m someone’s s o m e o n e ’ s perceptions p e r c e p t i o n s or o r experiences. e x p e r i e n c e s . ANOMALIES A N O M A L I E S may m a y be b e found f o u n d during, d u r i n g , but b u t not n o t limited l i m i t e d to, t o , the t h e review, r e v i e w , test, t e s t , analysis, a n a l y s i s , compilation, c o m p i l a t i o n , or o r use u s e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S or o r applicable a p p l i c a b l e documentation d o c u m e n t a t i o n NOTE N O T E Based B a s e d on o n [IEEE [ I E E E 1044:1993, 1 0 4 4 : 1 9 9 3 , definition d e f i n i t i o n 3.1]. 3 . 1 ] . 3.3 3 . 3 ARCHITECTURE A R C H I T E C T U R E organizational o r g a n i z a t i o n a l structure s t r u c t u r e of o f a a SYSTEM S Y S T E M or o r component c o m p o n e n t Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [IEEE [ I E E E 610.12:1990] 6 1 0 . 1 2 : 1 9 9 0 ] 3.4 3 . 4 CHANGE C H A N G E REQUEST R E Q U E S T a a documented d o c u m e n t e d specification s p e c i f i c a t i o n of o f a a change c h a n g e to t o be b e made m a d e to t o a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T 3.5 3 . 5 CONFIGURATION C O N F I G U R A T I O N ITEM I T E M entity e n t i t y that t h a t can c a n be b e uniquely u n i q u e l y identified i d e n t i f i e d at a t a a given g i v e n reference r e f e r e n c e point p o i n t NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , 3.6 3 . 6 4,7. 4 , 7 . 3.6 3 . 6 DELIVERABLE D E L I V E R A B L E required r e q u i r e d result r e s u l t or o r output o u t p u t (includes ( i n c l u d e s documentation) d o c u m e n t a t i o n ) of o f an a n ACTIVITY A C T I V I T Y or o r TASK T A S K granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 11 1 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.7 3 . 7 EVALUATION E V A L U A T I O N a a systematic s y s t e m a t i c determination d e t e r m i n a t i o n of o f the t h e extent e x t e n t to t o which w h i c h an a n entity e n t i t y meets m e e t s its i t s specified s p e c i f i e d criteria c r i t e r i a [ISO/IEC [ I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , 3.9 3 . 9 4.12] 4 . 1 2 ] 3.8 3 . 8 HARM H A R M physical p h y s i c a l injury, i n j u r y , damage, d a m a g e , or o r both b o t h to t o the t h e health h e a l t h of o f people p e o p l e or o r damage d a m a g e to t o property p r o p e r t y or o r the t h e environment e n v i r o n m e n t [ISO/IEC [ I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.3 3 . 3 ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.2] 2 . 2 ] 3.9 3 . 9 HAZARD H A Z A R D potential p o t e n t i a l source s o u r c e of o f HARM H A R M [ISO/IEC [ I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.5 3 . 5 ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.3] 2 . 3 ] 3.10 3 . 1 0 MANUFACTURER M A N U F A C T U R E R natural n a t u r a l or o r legal l e g a l person p e r s o n with w i t h responsibility r e s p o n s i b i l i t y for f o r designing, d e s i g n i n g , manufacturing, m a n u f a c t u r i n g , packaging, p a c k a g i n g , or o r labelling l a b e l l i n g a a MEDICAL M E D I C A L DEVICE; D E V I C E ; assembling a s s e m b l i n g a a SYSTEM; S Y S T E M ; or o r adapting a d a p t i n g a a MEDICAL M E D I C A L DEVICE D E V I C E before b e f o r e it i t is i s placed p l a c e d on o n the t h e market m a r k e t and/or a n d / o r put p u t into i n t o service, s e r v i c e , regardless r e g a r d l e s s of o f whether w h e t h e r these t h e s e operations o p e r a t i o n s are a r e carried c a r r i e d out o u t by b y that t h a t person p e r s o n or o r by b y a a third t h i r d party p a r t y on o n that t h a t person’s p e r s o n ’ s behalf b e h a l f NOTE N O T E 1 1 Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e fact f a c t that t h a t the t h e provisions p r o v i s i o n s of o f national n a t i o n a l or o r regional r e g i o n a l regulations r e g u l a t i o n s can c a n apply a p p l y to t o the t h e definition d e f i n i t i o n of o f manufacturer. m a n u f a c t u r e r . NOTE N O T E 2 2 For F o r a a definition d e f i n i t i o n of o f labelling, l a b e l l i n g , see s e e ISO I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , definition d e f i n i t i o n 3.6. 3 . 6 . [ISO [ I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007, 2 0 0 7 , 2.6 2 . 6 2,8] 2 , 8 ] 3.11 3 . 1 1 MEDICAL M E D I C A L DEVICE D E V I C E any a n y instrument, i n s t r u m e n t , apparatus, a p p a r a t u s , implement, i m p l e m e n t , machine, m a c h i n e , appliance, a p p l i a n c e , implant, i m p l a n t , in i n vitro v i t r o reagent r e a g e n t or o r calibrator, c a l i b r a t o r , software, s o f t w a r e , material m a t e r i a l or o r other o t h e r similar s i m i l a r or o r related r e l a t e d article, a r t i c l e , intended i n t e n d e d by b y the t h e MANUFACTURER M A N U F A C T U R E R to t o be b e used, u s e d , alone a l o n e or o r in i n combination, c o m b i n a t i o n , for f o r human h u m a n beings b e i n g s for f o r one o n e or o r more m o r e of o f the t h e specific s p e c i f i c purpose(s) p u r p o s e ( s ) of o f – – diagnosis, d i a g n o s i s , prevention, p r e v e n t i o n , monitoring, m o n i t o r i n g , treatment t r e a t m e n t or o r alleviation a l l e v i a t i o n of o f disease, d i s e a s e , – – diagnosis, d i a g n o s i s , monitoring, m o n i t o r i n g , treatment, t r e a t m e n t , alleviation a l l e v i a t i o n of o f or o r compensation c o m p e n s a t i o n for f o r an a n injury, i n j u r y , – – investigation, i n v e s t i g a t i o n , replacement, r e p l a c e m e n t , modification, m o d i f i c a t i o n , or o r support s u p p o r t of o f the t h e anatomy a n a t o m y or o r of o f a a physiological p h y s i o l o g i c a l PROCESS, P R O C E S S , – – supporting s u p p o r t i n g or o r sustaining s u s t a i n i n g life, l i f e , – – control c o n t r o l of o f conception, c o n c e p t i o n , – – disinfection d i s i n f e c t i o n of o f MEDICAL M E D I C A L DEVICES, D E V I C E S , – – providing p r o v i d i n g information i n f o r m a t i o n for f o r medical m e d i c a l purposes p u r p o s e s by b y means m e a n s of o f in i n vitro v i t r o examination e x a m i n a t i o n of o f specimens s p e c i m e n s derived d e r i v e d from f r o m the t h e human h u m a n body, b o d y , and a n d which w h i c h does d o e s not n o t achieve a c h i e v e its i t s primary p r i m a r y intended i n t e n d e d action a c t i o n in i n or o r on o n the t h e human h u m a n body b o d y by b y pharmacological, p h a r m a c o l o g i c a l , immunological i m m u n o l o g i c a l or o r metabolic m e t a b o l i c means, m e a n s , but b u t which w h i c h may m a y be b e assisted a s s i s t e d in i n its i t s function f u n c t i o n by b y such s u c h means m e a n s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E 1 1 This T h i s definition d e f i n i t i o n has h a s been b e e n developed d e v e l o p e d by b y the t h e Global G l o b a l Harmonization H a r m o n i z a t i o n Task T a s k Force F o r c e (GHTF). ( G H T F ) . See S e e bibliographic b i b l i o g r a p h i c reference r e f e r e n c e [15] [ 1 5 ] (in ( i n ISO I S O 13485:2003). 1 3 4 8 5 : 2 0 0 3 ) . [ISO [ I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , definition d e f i n i t i o n 3.7] 3 . 7 ] NOTE N O T E 2 2 Some S o m e differences d i f f e r e n c e s can c a n occur o c c u r in i n the t h e definitions d e f i n i t i o n s used u s e d in i n regulations r e g u l a t i o n s of o f each e a c h country. c o u n t r y . NOTE N O T E 3 3 In I n conjunction c o n j u n c t i o n with w i t h IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 and a n d IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 the t h e term t e r m “medical “ m e d i c a l device” d e v i c e ” assumes a s s u m e s the t h e same s a m e meaning m e a n i n g as a s ME M E EQUIPMENT E Q U I P M E N T or o r ME M E SYSTEM S Y S T E M (which ( w h i c h are a r e defined d e f i n e d terms t e r m s of o f IEC I E C 60601-1). 6 0 6 0 1 - 1 ) . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 12 1 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.12 3 . 1 2 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E SOFTWARE S O F T W A R E SYSTEM S Y S T E M that t h a t has h a s been b e e n developed d e v e l o p e d for f o r the t h e purpose p u r p o s e of o f being b e i n g incorporated i n c o r p o r a t e d into i n t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E being b e i n g developed d e v e l o p e d or o r that t h a t is i s intended i n t e n d e d for f o r use u s e as a s a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right r i g h t NOTE N O T E This T h i s includes i n c l u d e s a a MEDICAL M E D I C A L DEVICE D E V I C E software s o f t w a r e product, p r o d u c t , which w h i c h then t h e n is i s a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right. r i g h t . 3.13 3 . 1 3 PROBLEM P R O B L E M REPORT R E P O R T a a record r e c o r d of o f actual a c t u a l or o r potential p o t e n t i a l behaviour b e h a v i o u r of o f a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T that t h a t a a user u s e r or o r other o t h e r interested i n t e r e s t e d person p e r s o n believes b e l i e v e s to t o be b e unsafe, u n s a f e , inappropriate i n a p p r o p r i a t e for f o r the t h e intended i n t e n d e d use u s e or o r contrary c o n t r a r y to t o specification s p e c i f i c a t i o n NOTE N O T E 1 1 This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t every e v e r y PROBLEM P R O B L E M REPORT R E P O R T results r e s u l t s in i n a a change c h a n g e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T . . A A MANUFACTURER M A N U F A C T U R E R can c a n reject r e j e c t a a PROBLEM P R O B L E M REPORT R E P O R T as a s a a misunderstanding, m i s u n d e r s t a n d i n g , error e r r o r or o r insignificant i n s i g n i f i c a n t event. e v e n t . NOTE N O T E 2 2 A A PROBLEM P R O B L E M REPORT R E P O R T can c a n relate r e l a t e to t o a a released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T or o r to t o a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T that t h a t is i s still s t i l l under u n d e r development. d e v e l o p m e n t . NOTE N O T E 3 3 This T h i s standard s t a n d a r d requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o perform p e r f o r m extra e x t r a decision d e c i s i o n making m a k i n g steps s t e p s (see ( s e e Clause C l a u s e 6) 6 ) for f o r a a PROBLEM P R O B L E M REPORT R E P O R T relating r e l a t i n g to t o a a released r e l e a s e d product p r o d u c t to t o ensure e n s u r e that t h a t regulatory r e g u l a t o r y actions a c t i o n s are a r e identified i d e n t i f i e d and a n d implemented. i m p l e m e n t e d . 3.14 3 . 1 4 PROCESS P R O C E S S a a set s e t of o f interrelated i n t e r r e l a t e d or o r interacting i n t e r a c t i n g ACTIVITIES A C T I V I T I E S that t h a t transform t r a n s f o r m inputs i n p u t s into i n t o outputs o u t p u t s [ISO [ I S O 9000:2000, 9 0 0 0 : 2 0 0 0 , definition d e f i n i t i o n 3.4.1] 3 . 4 . 1 ] NOTE N O T E The T h e term t e r m “ACTIVITIES” “ A C T I V I T I E S ” covers c o v e r s use u s e of o f resources. r e s o u r c e s . 3.15 3 . 1 5 REGRESSION R E G R E S S I O N TESTING T E S T I N G the t h e testing t e s t i n g required r e q u i r e d to t o determine d e t e r m i n e that t h a t a a change c h a n g e to t o a a SYSTEM S Y S T E M component c o m p o n e n t has h a s not n o t adversely a d v e r s e l y affected a f f e c t e d functionality, f u n c t i o n a l i t y , reliability r e l i a b i l i t y or o r performance p e r f o r m a n c e and a n d has h a s not n o t introduced i n t r o d u c e d additional a d d i t i o n a l defects d e f e c t s [ISO/IEC [ I S O / I E C 90003:2004, 9 0 0 0 3 : 2 0 0 4 , definition d e f i n i t i o n 3.11] 3 . 1 1 ] 3.16 3 . 1 6 RISK R I S K combination c o m b i n a t i o n of o f the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f HARM H A R M and a n d the t h e severity s e v e r i t y of o f that t h a t HARM H A R M [ISO/IEC [ I S O / I E C Guide G u i d e 51:1999 5 1 : 1 9 9 9 definition d e f i n i t i o n 3.2 3 . 2 ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.16] 2 . 1 6 ] 3.17 3 . 1 7 RISK R I S K ANALYSIS A N A L Y S I S systematic s y s t e m a t i c use u s e of o f available a v a i l a b l e information i n f o r m a t i o n to t o identify i d e n t i f y HAZARDS H A Z A R D S and a n d to t o estimate e s t i m a t e the t h e RISK R I S K [ISO/IEC [ I S O / I E C Guide G u i d e 51:1999 5 1 : 1 9 9 9 definition d e f i n i t i o n 3.10 3 . 1 0 ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.17] 2 . 1 7 ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 3.18 3 . 1 8 RISK R I S K CONTROL C O N T R O L PROCESS P R O C E S S in i n which w h i c h decisions d e c i s i o n s are a r e made m a d e and a n d RISKS R I S K S are a r e reduced r e d u c e d to, t o , or o r maintained m a i n t a i n e d within, w i t h i n , specified s p e c i f i e d levels l e v e l s [ISO [ I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007, 2 0 0 7 , 2.16, 2 . 1 6 , modified m o d i f i e d 2.19] 2 . 1 9 ] 3.19 3 . 1 9 RISK R I S K MANAGEMENT M A N A G E M E N T systematic s y s t e m a t i c application a p p l i c a t i o n of o f management m a n a g e m e n t policies, p o l i c i e s , procedures, p r o c e d u r e s , and a n d practices p r a c t i c e s to t o the t h e TASKS T A S K S of o f analyzing, a n a l y z i n g , evaluating, e v a l u a t i n g , and a n d controlling c o n t r o l l i n g RISK R I S K [ISO [ I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007, 2 0 0 7 , 2.18 2 . 1 8 2.22, 2 . 2 2 , modified m o d i f i e d – – The T h e phrase p h r a s e "and " a n d monitoring" m o n i t o r i n g " has h a s been b e e n removed] r e m o v e d ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 13 1 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.20 3 . 2 0 RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E set s e t of o f records r e c o r d s and a n d other o t h e r documents, d o c u m e n t s , not n o t necessarily n e c e s s a r i l y contiguous, c o n t i g u o u s , that t h a t are a r e produced p r o d u c e d by b y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S [ISO [ I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007, 2 0 0 7 , 2.19 2 . 1 9 2.23] 2 . 2 3 ] 3.21 3 . 2 1 SAFETY S A F E T Y freedom f r e e d o m from f r o m unacceptable u n a c c e p t a b l e RISK R I S K [ISO/IEC [ I S O / I E C Guide G u i d e 51:1999 5 1 : 1 9 9 9 definition d e f i n i t i o n 3.1 3 . 1 ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.24] 2 . 2 4 ] 3.22 3 . 2 2 SECURITY S E C U R I T Y protection p r o t e c t i o n of o f information i n f o r m a t i o n and a n d data d a t a so s o that t h a t unauthorized u n a u t h o r i z e d people p e o p l e persons p e r s o n s or o r systems s y s t e m s cannot c a n n o t read r e a d or o r modify m o d i f y them t h e m and a n d so s o that t h a t an a n authorized a u t h o r i z e d persons p e r s o n s or o r systems s y s t e m s are a r e not n o t denied d e n i e d access a c c e s s to t o them t h e m NOTE N O T E Based B a s e d on o n [ISO/IEC [ I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , 3.25 3 . 2 5 4.39]. 4 . 3 9 ] . 3.23 3 . 2 3 SERIOUS S E R I O U S INJURY I N J U R Y injury i n j u r y or o r illness i l l n e s s that t h a t directly d i r e c t l y or o r indirectly: i n d i r e c t l y : is i s life l i f e threatening, t h r e a t e n i n g , results r e s u l t s in i n permanent p e r m a n e n t impairment i m p a i r m e n t of o f a a body b o d y function f u n c t i o n or o r permanent p e r m a n e n t damage d a m a g e to t o a a body b o d y structure, s t r u c t u r e , or o r necessitates n e c e s s i t a t e s medical m e d i c a l or o r surgical s u r g i c a l intervention i n t e r v e n t i o n to t o prevent p r e v e n t permanent p e r m a n e n t impairment i m p a i r m e n t of o f a a body b o d y function f u n c t i o n or o r permanent p e r m a n e n t damage d a m a g e to t o a a body b o d y structure s t r u c t u r e NOTE N O T E Permanent P e r m a n e n t impairment i m p a i r m e n t means m e a n s an a n irreversible i r r e v e r s i b l e impairment i m p a i r m e n t or o r damage d a m a g e to t o a a body b o d y structure s t r u c t u r e or o r function f u n c t i o n excluding e x c l u d i n g trivial t r i v i a l impairment i m p a i r m e n t or o r damage. d a m a g e . 3.24 3 . 2 4 SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L conceptual c o n c e p t u a l structure s t r u c t u r e spanning s p a n n i n g the t h e life l i f e of o f the t h e software s o f t w a r e from f r o m definition d e f i n i t i o n of o f its i t s requirements r e q u i r e m e n t s to t o its i t s release r e l e a s e for f o r manufacturing, m a n u f a c t u r i n g , which: w h i c h : – – identifies i d e n t i f i e s the t h e PROCESS, P R O C E S S , ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S involved i n v o l v e d in i n development d e v e l o p m e n t of o f a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T , , – – describes d e s c r i b e s the t h e sequence s e q u e n c e of o f and a n d dependency d e p e n d e n c y between b e t w e e n ACTIVITIES A C T I V I T I E S and a n d TASKS, T A S K S , and a n d – – identifies i d e n t i f i e s the t h e milestones m i l e s t o n e s at a t which w h i c h the t h e completeness c o m p l e t e n e s s of o f specified s p e c i f i e d DELIVERABLES D E L I V E R A B L E S is i s verified. v e r i f i e d . NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:1995, 1 2 2 0 7 : 1 9 9 5 , definition d e f i n i t i o n 3.11 3 . 1 1 3.25 3 . 2 5 SOFTWARE S O F T W A R E ITEM I T E M any a n y identifiable i d e n t i f i a b l e part p a r t of o f a a computer c o m p u t e r program, p r o g r a m , i.e., i . e . , source s o u r c e code, c o d e , object o b j e c t code, c o d e , control c o n t r o l code, c o d e , control c o n t r o l data, d a t a , or o r a a collection c o l l e c t i o n of o f these t h e s e items i t e m s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E Three T h r e e terms t e r m s identify i d e n t i f y the t h e software s o f t w a r e decomposition. d e c o m p o s i t i o n . The T h e top t o p level l e v e l is i s the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e lowest l o w e s t level l e v e l that t h a t is i s not n o t further f u r t h e r decomposed d e c o m p o s e d is i s the t h e SOFTWARE S O F T W A R E UNIT. U N I T . All A l l levels l e v e l s of o f composition, c o m p o s i t i o n , including i n c l u d i n g the t h e top t o p and a n d bottom b o t t o m levels, l e v e l s , can c a n be b e called c a l l e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , then, t h e n , is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d each e a c h SOFTWARE S O F T W A R E ITEM I T E M is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E UNITS U N I T S or o r decomposable d e c o m p o s a b l e SOFTWARE S O F T W A R E ITEMS. I T E M S . The T h e responsibility r e s p o n s i b i l i t y is i s left l e f t to t o the t h e MANUFACTURER M A N U F A C T U R E R to t o provide p r o v i d e the t h e definition d e f i n i t i o n and a n d granularity g r a n u l a r i t y of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SOFTWARE S O F T W A R E UNITS. U N I T S . NOTE N O T E 2 2 Based B a s e d on o n [ISO/IEC [ I S O / I E C 90003:2004, 9 0 0 0 3 : 2 0 0 4 , 3.14, 3 . 1 4 , modified m o d i f i e d and a n d ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4.41] 4 . 4 1 ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 14 1 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.26 3 . 2 6 SOFTWARE S O F T W A R E PRODUCT P R O D U C T set s e t of o f computer c o m p u t e r programs, p r o g r a m s , procedures, p r o c e d u r e s , and a n d possibly p o s s i b l y associated a s s o c i a t e d documentation d o c u m e n t a t i o n and a n d data d a t a [ISO/IEC [ I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 definition d e f i n i t i o n 3.26] 3 . 2 6 ] Not N o t used u s e d 3.27 3 . 2 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M integrated i n t e g r a t e d collection c o l l e c t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S organized o r g a n i z e d to t o accomplish a c c o m p l i s h a a specific s p e c i f i c function f u n c t i o n or o r set s e t of o f functions f u n c t i o n s 3.28 3 . 2 8 SOFTWARE S O F T W A R E UNIT U N I T SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s not n o t subdivided s u b d i v i d e d into i n t o other o t h e r items i t e m s NOTE N O T E S S OFTWARE O F T W A R E UNITS U N I T S can c a n be b e used u s e d for f o r the t h e purpose p u r p o s e of o f software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t or o r testing. t e s t i n g . The T h e granularity g r a n u l a r i t y of o f SOFTWARE S O F T W A R E UNITS U N I T S is i s defined d e f i n e d by b y the t h e MANUFACTURER M A N U F A C T U R E R (see ( s e e B.3). B . 3 ) . 3.29 3 . 2 9 SOUP S O U P software s o f t w a r e of o f unknown u n k n o w n provenance p r o v e n a n c e (acronym) ( a c r o n y m ) SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s already a l r e a d y developed d e v e l o p e d and a n d generally g e n e r a l l y available a v a i l a b l e and a n d that t h a t has h a s not n o t been b e e n developed d e v e l o p e d for f o r the t h e purpose p u r p o s e of o f being b e i n g incorporated i n c o r p o r a t e d into i n t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E (also ( a l s o known k n o w n as a s “off- “ o f f - the- t h e - shelf s h e l f software”) s o f t w a r e ” ) or o r SOFTWARE S O F T W A R E ITEM I T E M previously p r e v i o u s l y developed d e v e l o p e d for f o r which w h i c h adequate a d e q u a t e records r e c o r d s of o f the t h e development d e v e l o p m e n t PROCESSES P R O C E S S E S are a r e not n o t available a v a i l a b l e NOTE N O T E A A MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E SYSTEM S Y S T E M in i n itself i t s e l f cannot c a n n o t be b e claimed c l a i m e d to t o be b e SOUP. S O U P . 3.30 3 . 3 0 SYSTEM S Y S T E M integrated i n t e g r a t e d composite c o m p o s i t e consisting c o n s i s t i n g of o f one o n e or o r more m o r e of o f the t h e PROCESSES, P R O C E S S E S , hardware, h a r d w a r e , software, s o f t w a r e , facilities, f a c i l i t i e s , and a n d people, p e o p l e , that t h a t provides p r o v i d e s a a capability c a p a b i l i t y to t o satisfy s a t i s f y a a stated s t a t e d need n e e d or o r objective o b j e c t i v e NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C [ISO/IEC [ I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , 3.31 3 . 3 1 4.48]. 4 . 4 8 ] . 3.31 3 . 3 1 TASK T A S K a a single s i n g l e piece p i e c e of o f work w o r k that t h a t needs n e e d s to t o be b e done d o n e 3.32 3 . 3 2 TRACEABILITY T R A C E A B I L I T Y degree d e g r e e to t o which w h i c h a a relationship r e l a t i o n s h i p can c a n be b e established e s t a b l i s h e d between b e t w e e n two t w o or o r more m o r e products p r o d u c t s of o f the t h e development d e v e l o p m e n t PROCESS P R O C E S S [IEEE [ I E E E 610.12:1990] 6 1 0 . 1 2 : 1 9 9 0 ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E Requirements, R e q u i r e m e n t s , architecture, a r c h i t e c t u r e , risk r i s k control c o n t r o l measures, m e a s u r e s , etc. e t c . are a r e examples e x a m p l e s of o f deliverables d e l i v e r a b l e s of o f the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . 3.33 3 . 3 3 VERIFICATION V E R I F I C A T I O N confirmation c o n f i r m a t i o n through t h r o u g h provision p r o v i s i o n of o f objective o b j e c t i v e evidence e v i d e n c e that t h a t specified s p e c i f i e d requirements r e q u i r e m e n t s have h a v e been b e e n fulfilled f u l f i l l e d NOTE N O T E 1 1 “Verified” “ V e r i f i e d ” is i s used u s e d to t o designate d e s i g n a t e the t h e corresponding c o r r e s p o n d i n g status. s t a t u s . [ISO [ I S O 9000:2000, 9 0 0 0 : 2 0 0 0 , definition d e f i n i t i o n 3.8.4] 3 . 8 . 4 ] NOTE N O T E 2 2 In I n design d e s i g n and a n d development, d e v e l o p m e n t , VERIFICATION V E R I F I C A T I O N concerns c o n c e r n s the t h e PROCESS P R O C E S S of o f examining e x a m i n i n g the t h e result r e s u l t of o f a a given g i v e n ACTIVITY A C T I V I T Y to t o determine d e t e r m i n e conformity c o n f o r m i t y with w i t h the t h e stated s t a t e d requirement r e q u i r e m e n t for f o r that t h a t ACTIVITY. A C T I V I T Y . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 15 1 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.34 3 . 3 4 VERSION V E R S I O N identified i d e n t i f i e d instance i n s t a n c e of o f a a CONFIGURATION C O N F I G U R A T I O N ITEM I T E M NOTE N O T E 1 1 Modification M o d i f i c a t i o n to t o a a VERSION V E R S I O N of o f a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT, P R O D U C T , resulting r e s u l t i n g in i n a a new n e w VERSION, V E R S I O N , requires r e q u i r e s software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t action. a c t i o n . NOTE N O T E 2 2 Based B a s e d on o n ISO/IEC I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , 3.37 3 . 3 7 4.56. 4 . 5 6 . 3.35 3 . 3 5 HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N circumstance c i r c u m s t a n c e in i n which w h i c h people, p e o p l e , property p r o p e r t y or o r the t h e environment e n v i r o n m e n t are a r e exposed e x p o s e d to t o one o n e or o r more m o r e HAZARD(S) H A Z A R D ( S ) [SOURCE: [ S O U R C E : ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.4] 2 . 4 ] 3.36 3 . 3 6 LEGACY L E G A C Y SOFTWARE S O F T W A R E MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E which w h i c h was w a s legally l e g a l l y placed p l a c e d on o n the t h e market m a r k e t and a n d is i s still s t i l l marketed m a r k e t e d today t o d a y but b u t for f o r which w h i c h there t h e r e is i s insufficient i n s u f f i c i e n t objective o b j e c t i v e evidence e v i d e n c e that t h a t it i t was w a s developed d e v e l o p e d in i n compliance c o m p l i a n c e with w i t h the t h e current c u r r e n t version v e r s i o n of o f this t h i s standard s t a n d a r d 3.37 3 . 3 7 RELEASE R E L E A S E particular p a r t i c u l a r VERSION V E R S I O N of o f a a CONFIGURATION C O N F I G U R A T I O N ITEM I T E M that t h a t is i s made m a d e available a v a i l a b l e for f o r a a specific s p e c i f i c purpose p u r p o s e NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , definition d e f i n i t i o n 4.35. 4 . 3 5 . 3.38 3 . 3 8 RESIDUAL R E S I D U A L RISK R I S K RISK R I S K remaining r e m a i n i n g after a f t e r RISK R I S K CONTROL C O N T R O L measures m e a s u r e s have h a v e been b e e n taken t a k e n NOTE N O T E 1 1 Adapted A d a p t e d from f r o m ISO/IEC I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.9. 3 . 9 . NOTE N O T E 2 2 ISO/IEC I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.9 3 . 9 uses u s e s the t h e term t e r m “protective “ p r o t e c t i v e measures” m e a s u r e s ” rather r a t h e r than t h a n “RISK “ R I S K CONTROL C O N T R O L measures.” m e a s u r e s . ” However, H o w e v e r , in i n the t h e context c o n t e x t of o f this t h i s International I n t e r n a t i o n a l Standard, S t a n d a r d , “protective “ p r o t e c t i v e measures” m e a s u r e s ” are a r e only o n l y one o n e option o p t i o n for f o r controlling c o n t r o l l i n g RISK R I S K as a s described d e s c r i b e d in i n 6.2 6 . 2 [of [ o f ISO I S O 14971:2007]. 1 4 9 7 1 : 2 0 0 7 ] . [SOURCE: [ S O U R C E : ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.15]. 2 . 1 5 ] . 3.39 3 . 3 9 RISK R I S K ESTIMATION E S T I M A T I O N PROCESS P R O C E S S used u s e d to t o assign a s s i g n values v a l u e s to t o the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f HARM H A R M and a n d the t h e severity s e v e r i t y of o f that t h a t HARM H A R M [SOURCE: [ S O U R C E : ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 2.20] 2 . 2 0 ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 3.40 3 . 4 0 RISK R I S K EVALUATION E V A L U A T I O N PROCESS P R O C E S S of o f comparing c o m p a r i n g the t h e estimated e s t i m a t e d RISK R I S K against a g a i n s t given g i v e n RISK R I S K criteria c r i t e r i a to t o determine d e t e r m i n e the t h e acceptability a c c e p t a b i l i t y of o f the t h e RISK R I S K [SOURCE: [ S O U R C E : ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 2.21] 2 . 2 1 ] 4 4 * * General G e n e r a l requirements r e q u i r e m e n t s 4.1 4 . 1 * * Quality Q u a l i t y management m a n a g e m e n t system s y s t e m The T h e MANUFACTURER M A N U F A C T U R E R of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E shall s h a l l demonstrate d e m o n s t r a t e the t h e ability a b i l i t y to t o provide p r o v i d e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t consistently c o n s i s t e n t l y meets m e e t s customer c u s t o m e r requirements r e q u i r e m e n t s and a n d applicable a p p l i c a b l e regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 16 1 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E 1 1 Demonstration D e m o n s t r a t i o n of o f this t h i s ability a b i l i t y can c a n be b e by b y the t h e use u s e of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m that t h a t complies c o m p l i e s with: w i t h : - - ISO I S O 13485 1 3 4 8 5 [8]; [ 8 ] ; or o r - - a a national n a t i o n a l quality q u a l i t y management m a n a g e m e n t system s y s t e m standard; s t a n d a r d ; or o r - - a a quality q u a l i t y management m a n a g e m e n t system s y s t e m required r e q u i r e d by b y national n a t i o n a l regulation. r e g u l a t i o n . NOTE N O T E 2 2 Guidance G u i d a n c e for f o r applying a p p l y i n g quality q u a l i t y management m a n a g e m e n t system s y s t e m requirements r e q u i r e m e n t s to t o software s o f t w a r e can c a n be b e found f o u n d in i n ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15]. [ 1 5 ] . 4.2 4 . 2 * * RISK R I S K MANAGEMENT M A N A G E M E N T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l apply a p p l y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S complying c o m p l y i n g with w i t h ISO I S O 14971. 1 4 9 7 1 . 4.3 4 . 3 * * Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l assign a s s i g n to t o each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M a a software s o f t w a r e safety s a f e t y class c l a s s (A, ( A , B, B , or o r C) C ) according a c c o r d i n g to t o the t h e possible p o s s i b l e effects e f f e c t s on o n RISK R I S K of o f HARM H A R M to t o the t h e patient, p a t i e n t , operator, o p e r a t o r , or o r other o t h e r people p e o p l e resulting r e s u l t i n g from f r o m a a HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N to t o which w h i c h the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e in i n a a worst-case-scenario w o r s t - c a s e - s c e n a r i o as a s indicated i n d i c a t e d in i n Figure F i g u r e 3. 3 . IEC I E C Figure F i g u r e 3 3 – – Assigning A s s i g n i n g software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e software s o f t w a r e safety s a f e t y classes c l a s s e s shall s h a l l initially i n i t i a l l y be b e assigned a s s i g n e d based b a s e d on o n severity s e v e r i t y as a s follows: f o l l o w s : Class C l a s s A: A : No N o injury i n j u r y or o r damage d a m a g e to t o health h e a l t h is i s possible p o s s i b l e Class C l a s s B: B : Non-SERIOUS N o n - S E R I O U S INJURY I N J U R Y is i s possible p o s s i b l e Class C l a s s C: C : Death D e a t h or o r SERIOUS S E R I O U S INJURY I N J U R Y is i s possible p o s s i b l e If I f the t h e HAZARD H A Z A R D could c o u l d arise a r i s e from f r o m a a failure f a i l u r e of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M to t o behave b e h a v e as a s specified, s p e c i f i e d , the t h e probability p r o b a b i l i t y of o f such s u c h failure f a i l u r e shall s h a l l be b e assumed a s s u m e d to t o be b e 100 1 0 0 percent. p e r c e n t . If I f the t h e RISK R I S K of o f death d e a t h or o r SERIOUS S E R I O U S INJURY I N J U R Y arising a r i s i n g from f r o m a a software s o f t w a r e failure f a i l u r e is i s subsequently s u b s e q u e n t l y reduced r e d u c e d to t o an a n acceptable a c c e p t a b l e level l e v e l (as ( a s defined d e f i n e d by b y ISO I S O 14971) 1 4 9 7 1 ) by b y a a hardware h a r d w a r e RISK R I S K CONTROL C O N T R O L measure, m e a s u r e , either e i t h e r by b y reducing r e d u c i n g the t h e consequences c o n s e q u e n c e s of o f the t h e failure f a i l u r e or o r by b y reducing r e d u c i n g the t h e probability p r o b a b i l i t y of o f death d e a t h or o r SERIOUS S E R I O U S INJURY I N J U R Y arising a r i s i n g from f r o m that t h a t failure, f a i l u r e , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n may m a y be b e reduced r e d u c e d from f r o m C C to t o B; B ; and a n d if i f the t h e RISK R I S K of o f non- n o n - SERIOUS S E R I O U S INJURY I N J U R Y arising a r i s i n g from f r o m a a software s o f t w a r e failure f a i l u r e is i s similarly s i m i l a r l y reduced r e d u c e d to t o an a n acceptable a c c e p t a b l e level l e v e l by b y a a hardware h a r d w a r e RISK R I S K CONTROL C O N T R O L measure, m e a s u r e , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n may m a y be b e reduced r e d u c e d from f r o m B B to t o A. A . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 17 1 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s A A if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M cannot c a n n o t contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION; S I T U A T I O N ; or o r – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h does d o e s not n o t result r e s u l t in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s B B if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h results r e s u l t s in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d the t h e resulting r e s u l t i n g possible p o s s i b l e HARM H A R M is i s non-SERIOUS n o n - S E R I O U S INJURY. I N J U R Y . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s C C if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h results r e s u l t s in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d the t h e resulting r e s u l t i n g possible p o s s i b l e HARM H A R M is i s death d e a t h or o r SERIOUS S E R I O U S INJURY. I N J U R Y . For F o r a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M initially i n i t i a l l y classified c l a s s i f i e d as a s software s o f t w a r e safety s a f e t y class c l a s s B B or o r C, C , the t h e MANUFACTURER M A N U F A C T U R E R may m a y implement i m p l e m e n t additional a d d i t i o n a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M (including ( i n c l u d i n g revising r e v i s i n g the t h e system s y s t e m architecture a r c h i t e c t u r e containing c o n t a i n i n g the t h e SOFTWARE S O F T W A R E SYSTEM) S Y S T E M ) and a n d subsequently s u b s e q u e n t l y assign a s s i g n a a new n e w software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . NOTE N O T E 1 1 External E x t e r n a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s can c a n be b e hardware, h a r d w a r e , an a n independent i n d e p e n d e n t SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , health h e a l t h care c a r e procedures, p r o c e d u r e s , or o r other o t h e r means m e a n s to t o minimize m i n i m i z e that t h a t software s o f t w a r e can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . NOTE N O T E 2 2 See S e e ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 subclause s u b c l a u s e 3.2, 3 . 2 , Management M a n a g e m e n t Responsibilities, R e s p o n s i b i l i t i e s , for f o r the t h e definition d e f i n i t i o n of o f risk r i s k acceptability. a c c e p t a b i l i t y . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l assign a s s i g n to t o each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M that t h a t contributes c o n t r i b u t e s to t o the t h e implementation i m p l e m e n t a t i o n of o f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e a a software s o f t w a r e safety s a f e t y class c l a s s based b a s e d on o n the t h e possible p o s s i b l e effects e f f e c t s of o f the t h e HAZARD H A Z A R D that t h a t the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s controlling. c o n t r o l l i n g . Not N o t used. u s e d . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e software s o f t w a r e safety s a f e t y class c l a s s assigned a s s i g n e d to t o each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . When W h e n a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s decomposed d e c o m p o s e d into i n t o SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d when w h e n a a SOFTWARE S O F T W A R E ITEM I T E M is i s decomposed d e c o m p o s e d into i n t o further f u r t h e r SOFTWARE S O F T W A R E ITEMS, I T E M S , such s u c h SOFTWARE S O F T W A R E ITEMS I T E M S shall s h a l l inherit i n h e r i t the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e original o r i g i n a l SOFTWARE S O F T W A R E ITEM I T E M (or ( o r SOFTWARE S O F T W A R E SYSTEM) S Y S T E M ) unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R documents d o c u m e n t s a a rationale r a t i o n a l e for f o r classification c l a s s i f i c a t i o n into i n t o a a different d i f f e r e n t software s o f t w a r e safety s a f e t y class c l a s s (software ( s o f t w a r e safety s a f e t y classes c l a s s e s assigned a s s i g n e d according a c c o r d i n g to t o 4.3 4 . 3 a) a ) replacing r e p l a c i n g “SOFTWARE “ S O F T W A R E SYSTEM” S Y S T E M ” with w i t h “SOFTWARE “ S O F T W A R E ITEM”). I T E M ” ) . Such S u c h a a rationale r a t i o n a l e shall s h a l l explain e x p l a i n how h o w the t h e new n e w SOFTWARE S O F T W A R E ITEMS I T E M S are a r e segregated s e g r e g a t e d so s o that t h a t they t h e y may m a y be b e classified c l a s s i f i e d separately. s e p a r a t e l y . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e software s o f t w a r e safety s a f e t y class c l a s s of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M if i f that t h a t class c l a s s is i s different d i f f e r e n t from f r o m the t h e class c l a s s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M from f r o m which w h i c h it i t was w a s created c r e a t e d by b y decomposition. d e c o m p o s i t i o n . For F o r compliance c o m p l i a n c e with w i t h this t h i s standard, s t a n d a r d , wherever w h e r e v e r a a PROCESS P R O C E S S is i s required r e q u i r e d for f o r SOFTWARE S O F T W A R E ITEMS I T E M S of o f a a specific s p e c i f i c classification c l a s s i f i c a t i o n and a n d the t h e PROCESS P R O C E S S is i s necessarily n e c e s s a r i l y applied a p p l i e d when w h e n applying a p p l y i n g this t h i s standard s t a n d a r d to t o a a group g r o u p of o f SOFTWARE S O F T W A R E ITEMS, I T E M S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e PROCESSES P R O C E S S E S and a n d TASKS T A S K S which w h i c h are a r e required r e q u i r e d by b y the t h e classification c l a s s i f i c a t i o n of o f the t h e highest-classified h i g h e s t - c l a s s i f i e d SOFTWARE S O F T W A R E ITEM I T E M in i n the t h e group g r o u p unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R documents d o c u m e n t s in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E a a rationale r a t i o n a l e for f o r using u s i n g a a lower l o w e r classification. c l a s s i f i c a t i o n . For F o r each e a c h SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , until u n t i l a a software s o f t w a r e safety s a f e t y class c l a s s is i s assigned, a s s i g n e d , Class C l a s s C C requirements r e q u i r e m e n t s shall s h a l l apply. a p p l y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E In I n the t h e requirements r e q u i r e m e n t s clauses c l a u s e s and a n d subclauses s u b c l a u s e s that t h a t follow, f o l l o w , the t h e software s o f t w a r e safety s a f e t y classes c l a s s e s that t h a t the t h e requirement r e q u i r e m e n t must m u s t be b e performed p e r f o r m e d for f o r which w h i c h a a specific s p e c i f i c requirement r e q u i r e m e n t applies a p p l i e s are a r e identified i d e n t i f i e d following f o l l o w i n g the t h e requirement r e q u i r e m e n t in i n the t h e form f o r m [Class [ C l a s s . . . . .]. . ] . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 18 1 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 4.4 4 . 4 * * LEGACY L E G A C Y SOFTWARE S O F T W A R E 4.4.1 4 . 4 . 1 General G e n e r a l As A s an a n alternative a l t e r n a t i v e to t o applying a p p l y i n g Clauses C l a u s e s 5 5 through t h r o u g h 9 9 of o f this t h i s standard, s t a n d a r d , compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E may m a y be b e demonstrated d e m o n s t r a t e d as a s indicated i n d i c a t e d in i n 4.4.2 4 . 4 . 2 to t o 4.4.5. 4 . 4 . 5 . 4.4.2 4 . 4 . 2 RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S In I n accordance a c c o r d a n c e with w i t h 4.2 4 . 2 of o f this t h i s standard, s t a n d a r d , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : assess a s s e s s any a n y feedback, f e e d b a c k , including i n c l u d i n g post-production p o s t - p r o d u c t i o n information, i n f o r m a t i o n , on o n LEGACY L E G A C Y SOFTWARE S O F T W A R E regarding r e g a r d i n g incidents i n c i d e n t s and a n d / / or o r near n e a r incidents, i n c i d e n t s , both b o t h from f r o m inside i n s i d e its i t s own o w n organization o r g a n i z a t i o n and a n d / / or o r from f r o m users; u s e r s ; perform p e r f o r m RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S associated a s s o c i a t e d with w i t h continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , considering c o n s i d e r i n g the t h e following f o l l o w i n g aspects: a s p e c t s : – – integration i n t e g r a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E architecture; a r c h i t e c t u r e ; – – continuing c o n t i n u i n g validity v a l i d i t y of o f RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , implemented i m p l e m e n t e d as a s part p a r t of o f the t h e LEGACY L E G A C Y SOFTWARE; S O F T W A R E ; – – identification i d e n t i f i c a t i o n of o f HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S associated a s s o c i a t e d with w i t h the t h e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE; S O F T W A R E ; – – identification i d e n t i f i c a t i o n of o f potential p o t e n t i a l causes c a u s e s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E contributing c o n t r i b u t i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION; S I T U A T I O N ; – – definition d e f i n i t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s for f o r each e a c h potential p o t e n t i a l cause c a u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E contributing c o n t r i b u t i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . 4.4.3 4 . 4 . 3 Gap G a p analysis a n a l y s i s Based B a s e d on o n the t h e software s o f t w a r e safety s a f e t y class c l a s s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E (see ( s e e 4.3), 4 . 3 ) , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m a a gap g a p analysis a n a l y s i s of o f available a v a i l a b l e DELIVERABLES D E L I V E R A B L E S against a g a i n s t those t h o s e required r e q u i r e d according a c c o r d i n g to t o 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7. 7 . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l assess a s s e s s the t h e continuing c o n t i n u i n g validity v a l i d i t y of o f available a v a i l a b l e DELIVERABLES. D E L I V E R A B L E S . Where W h e r e gaps g a p s are a r e identified, i d e n t i f i e d , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e potential p o t e n t i a l reduction r e d u c t i o n in i n RISK R I S K resulting r e s u l t i n g from f r o m the t h e generation g e n e r a t i o n of o f the t h e missing m i s s i n g DELIVERABLES D E L I V E R A B L E S and a n d associated a s s o c i a t e d ACTIVITIES. A C T I V I T I E S . Based B a s e d on o n this t h i s evaluation, e v a l u a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l determine d e t e r m i n e the t h e DELIVERABLES D E L I V E R A B L E S to t o be b e created c r e a t e d and a n d associated a s s o c i a t e d ACTIVITIES A C T I V I T I E S to t o be b e performed. p e r f o r m e d . The T h e minimum m i n i m u m DELIVERABLE D E L I V E R A B L E shall s h a l l be b e SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t records r e c o r d s (see ( s e e 5.7.5). 5 . 7 . 5 ) . NOTE N O T E Such S u c h gap g a p analysis a n a l y s i s should s h o u l d assure a s s u r e that t h a t RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , implemented i m p l e m e n t e d in i n LEGACY L E G A C Y SOFTWARE, S O F T W A R E , are a r e included i n c l u d e d in i n the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . 4.4.4 4 . 4 . 4 Gap G a p closure c l o s u r e activities a c t i v i t i e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h and a n d execute e x e c u t e a a plan p l a n to t o generate g e n e r a t e the t h e identified i d e n t i f i e d DELIVERABLES. D E L I V E R A B L E S . Where W h e r e available, a v a i l a b l e , objective o b j e c t i v e evidence e v i d e n c e may m a y be b e used u s e d to t o generate g e n e r a t e required r e q u i r e d DELIVERABLES D E L I V E R A B L E S without w i t h o u t performing p e r f o r m i n g ACTIVITIES A C T I V I T I E S required r e q u i r e d by b y 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7 5 . 7 and a n d Clause C l a u s e 7. 7 . NOTE N O T E A A plan p l a n on o n how h o w to t o address a d d r e s s the t h e identified i d e n t i f i e d gaps g a p s can c a n be b e included i n c l u d e d in i n a a software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n (see ( s e e 6.1). 6 . 1 ) . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e use u s e of o f the t h e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S for f o r handling h a n d l i n g problems p r o b l e m s detected d e t e c t e d in i n the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d DELIVERABLES D E L I V E R A B L E S in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 9. 9 . Changes C h a n g e s to t o the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E shall s h a l l be b e performed p e r f o r m e d in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 6. 6 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 4.4.5 4 . 4 . 5 Rationale R a t i o n a l e for f o r use u s e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E together t o g e t h e r with w i t h a a rationale r a t i o n a l e for f o r the t h e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E based b a s e d on o n the t h e outputs o u t p u t s of o f 4.4. 4 . 4 . NOTE N O T E Fulfilling F u l f i l l i n g 4.4 4 . 4 enables e n a b l e s further f u r t h e r use u s e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n accordance a c c o r d a n c e with w i t h IEC I E C 62304. 6 2 3 0 4 . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 19 1 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S 5.1 5 . 1 * * Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a software s o f t w a r e development d e v e l o p m e n t plan p l a n (or ( o r plans) p l a n s ) for f o r conducting c o n d u c t i n g the t h e ACTIVITIES A C T I V I T I E S of o f the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S appropriate a p p r o p r i a t e to t o the t h e scope, s c o p e , magnitude, m a g n i t u d e , and a n d software s o f t w a r e safety s a f e t y classifications c l a s s i f i c a t i o n s of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M to t o be b e developed. d e v e l o p e d . The T h e sOFTWARE s O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L shall s h a l l either e i t h e r be b e fully f u l l y defined d e f i n e d or o r be b e referenced r e f e r e n c e d in i n the t h e plan p l a n (or ( o r plans). p l a n s ) . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e following: f o l l o w i n g : the t h e PROCESSES P R O C E S S E S to t o be b e used u s e d in i n the t h e development d e v e l o p m e n t of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M (see ( s e e Note N o t e 4); 4 ) ; the t h e DELIVERABLES D E L I V E R A B L E S (includes ( i n c l u d e s documentation) d o c u m e n t a t i o n ) of o f the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS; T A S K S ; TRACEABILITY T R A C E A B I L I T Y between b e t w e e n SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , software s o f t w a r e requirements, r e q u i r e m e n t s , SOFTWARE S O F T W A R E SYSTEM S Y S T E M test, t e s t , and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software; s o f t w a r e ; software s o f t w a r e configuration c o n f i g u r a t i o n and a n d change c h a n g e management, m a n a g e m e n t , including i n c l u d i n g SOUP S O U P CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d software s o f t w a r e used u s e d to t o support s u p p o r t development; d e v e l o p m e n t ; and a n d software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n for f o r handling h a n d l i n g problems p r o b l e m s detected d e t e c t e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S , , DELIVERABLES D E L I V E R A B L E S and a n d ACTIVITIES A C T I V I T I E S at a t each e a c h stage s t a g e of o f the t h e life l i f e cycle. c y c l e . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 1 1 The T h e SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L can c a n identify i d e n t i f y different d i f f e r e n t elements e l e m e n t s (PROCESSES, ( P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , TASKS T A S K S and a n d DELIVERABLES) D E L I V E R A B L E S ) for f o r different d i f f e r e n t SOFTWARE S O F T W A R E ITEMS I T E M S according a c c o r d i n g to t o the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M of o f the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . NOTE N O T E 2 2 These T h e s e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S can c a n overlap o v e r l a p or o r interact i n t e r a c t and a n d can c a n be b e performed p e r f o r m e d iteratively i t e r a t i v e l y or o r recursively. r e c u r s i v e l y . It I t is i s not n o t the t h e intent i n t e n t to t o imply i m p l y that t h a t a a specific s p e c i f i c life l i f e cycle c y c l e model m o d e l should s h o u l d be b e used. u s e d . NOTE N O T E 3 3 Other O t h e r PROCESSES P R O C E S S E S are a r e described d e s c r i b e d in i n this t h i s standard s t a n d a r d separately s e p a r a t e l y from f r o m the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . This T h i s does d o e s not n o t imply i m p l y that t h a t they t h e y must m u s t be b e implemented i m p l e m e n t e d as a s separate s e p a r a t e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . The T h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e other o t h e r PROCESSES P R O C E S S E S can c a n be b e integrated i n t e g r a t e d into i n t o the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . NOTE N O T E 4 4 The T h e software s o f t w a r e development d e v e l o p m e n t plan p l a n can c a n reference r e f e r e n c e existing e x i s t i n g PROCESSES P R O C E S S E S or o r define d e f i n e new n e w ones. o n e s . NOTE N O T E 5 5 The T h e software s o f t w a r e development d e v e l o p m e n t plan p l a n may m a y be b e integrated i n t e g r a t e d in i n an a n overall o v e r a l l SYSTEM S Y S T E M development d e v e l o p m e n t plan. p l a n . 5.1.2 5 . 1 . 2 Keep K e e p software s o f t w a r e development d e v e l o p m e n t plan p l a n updated u p d a t e d The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l update u p d a t e the t h e plan p l a n as a s development d e v e l o p m e n t proceeds p r o c e e d s as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] 5.1.3 5 . 1 . 3 Software S o f t w a r e development d e v e l o p m e n t plan p l a n reference r e f e r e n c e to t o SYSTEM S Y S T E M design d e s i g n and a n d development d e v e l o p m e n t As A s inputs i n p u t s for f o r software s o f t w a r e development, d e v e l o p m e n t , SYSTEM S Y S T E M requirements r e q u i r e m e n t s shall s h a l l be b e referenced r e f e r e n c e d in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n by b y the t h e MANUFACTURER. M A N U F A C T U R E R . In I n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n procedures p r o c e d u r e s for f o r coordinating c o o r d i n a t i n g the t h e software s o f t w a r e development d e v e l o p m e n t and a n d the t h e design d e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n with w i t h the t h e system s y s t e m development d e v e l o p m e n t necessary n e c e s s a r y to t o satisfy s a t i s f y 4.1 4 . 1 (such ( s u c h as a s system s y s t e m integration, i n t e g r a t i o n , verification, v e r i f i c a t i o n , and a n d validation). v a l i d a t i o n ) . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E There T h e r e might m i g h t not n o t be b e a a difference d i f f e r e n c e between b e t w e e n SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s if i f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a stand s t a n d alone a l o n e SYSTEM S Y S T E M (software-only ( s o f t w a r e - o n l y device). d e v i c e ) . 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan: p l a n : granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} standards, s t a n d a r d s , methods, m e t h o d s , and a n d tools t o o l s associated a s s o c i a t e d with w i t h the t h e development d e v e l o p m e n t of o f SOFTWARE S O F T W A R E ITEMS I T E M S of o f class c l a s s C. C . [Class [ C l a s s C] C ] – – 20 2 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.1.5 5 . 1 . 5 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , a a plan p l a n to t o integrate i n t e g r a t e the t h e SOFTWARE S O F T W A R E ITEMS I T E M S (including ( i n c l u d i n g SOUP) S O U P ) and a n d perform p e r f o r m testing t e s t i n g during d u r i n g integration. i n t e g r a t i o n . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . NOTE N O T E 2 2 See S e e 5.6. 5 . 6 . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n the t h e following f o l l o w i n g VERIFICATION V E R I F I C A T I O N information: i n f o r m a t i o n : DELIVERABLES D E L I V E R A B L E S requiring r e q u i r i n g VERIFICATION; V E R I F I C A T I O N ; the t h e required r e q u i r e d VERIFICATION V E R I F I C A T I O N TASKS T A S K S for f o r each e a c h life l i f e cycle c y c l e ACTIVITY; A C T I V I T Y ; milestones m i l e s t o n e s at a t which w h i c h the t h e DELIVERABLES D E L I V E R A B L E S are a r e VERIFIED; V E R I F I E D ; and a n d the t h e acceptance a c c e p t a n c e criteria c r i t e r i a for f o r VERIFICATION V E R I F I C A T I O N of o f the t h e DELIVERABLES. D E L I V E R A B L E S . [Class [ C l a s s A, A , B, B , C] C ] 5.1.7 5 . 1 . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , a a plan p l a n to t o conduct c o n d u c t the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS, P R O C E S S , including i n c l u d i n g the t h e management m a n a g e m e n t of o f RISKS R I S K S relating r e l a t i n g to t o SOUP. S O U P . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 7. 7 . 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n information i n f o r m a t i o n about a b o u t the t h e documents d o c u m e n t s to t o be b e produced p r o d u c e d during d u r i n g the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle. c y c l e . For F o r each e a c h identified i d e n t i f i e d document d o c u m e n t or o r type t y p e of o f document d o c u m e n t the t h e following f o l l o w i n g information i n f o r m a t i o n shall s h a l l be b e included i n c l u d e d or o r referenced: r e f e r e n c e d : title, t i t l e , name n a m e or o r naming n a m i n g convention; c o n v e n t i o n ; purpose; p u r p o s e ; intended i n t e n d e d audience a u d i e n c e of o f document; d o c u m e n t ; and a n d d)c) d ) c ) procedures p r o c e d u r e s and a n d responsibilities r e s p o n s i b i l i t i e s for f o r development, d e v e l o p m e n t , review, r e v i e w , approval a p p r o v a l and a n d modification. m o d i f i c a t i o n . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 8 8 for f o r consideration c o n s i d e r a t i o n of o f configuration c o n f i g u r a t i o n management m a n a g e m e n t of o f documentation. d o c u m e n t a t i o n . 5.1.9 5 . 1 . 9 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t information i n f o r m a t i o n in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan. p l a n . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t information i n f o r m a t i o n shall s h a l l include i n c l u d e or o r reference: r e f e r e n c e : granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 21 2 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 the t h e classes, c l a s s e s , types, t y p e s , categories c a t e g o r i e s or o r lists l i s t s of o f items i t e m s to t o be b e controlled; c o n t r o l l e d ; the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t ACTIVITIES A C T I V I T I E S and a n d TASKS; T A S K S ; the t h e organization(s) o r g a n i z a t i o n ( s ) responsible r e s p o n s i b l e for f o r performing p e r f o r m i n g software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t and a n d ACTIVITIES; A C T I V I T I E S ; their t h e i r relationship r e l a t i o n s h i p with w i t h other o t h e r organizations, o r g a n i z a t i o n s , such s u c h as a s software s o f t w a r e development d e v e l o p m e n t or o r maintenance; m a i n t e n a n c e ; when w h e n the t h e items i t e m s are a r e to t o be b e placed p l a c e d under u n d e r configuration c o n f i g u r a t i o n control; c o n t r o l ; and a n d when w h e n the t h e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S is i s to t o be b e used. u s e d . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 8. 8 . 5.1.10 5 . 1 . 1 0 Supporting S u p p o r t i n g items i t e m s to t o be b e controlled c o n t r o l l e d The T h e items i t e m s to t o be b e controlled c o n t r o l l e d shall s h a l l include i n c l u d e tools, t o o l s , items i t e m s or o r settings, s e t t i n g s , used u s e d to t o develop d e v e l o p the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , which w h i c h could c o u l d impact i m p a c t the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 Examples E x a m p l e s of o f such s u c h items i t e m s include i n c l u d e compiler/assembler c o m p i l e r / a s s e m b l e r versions, v e r s i o n s , make m a k e files, f i l e s , batch b a t c h files, f i l e s , and a n d specific s p e c i f i c environment e n v i r o n m e n t settings. s e t t i n g s . NOTE N O T E 2 2 See S e e Clause C l a u s e 8. 8 . 5.1.11 5 . 1 . 1 1 Software S o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEM I T E M control c o n t r o l before b e f o r e VERIFICATION V E R I F I C A T I O N The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l plan p l a n to t o place p l a c e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S under u n d e r documented d o c u m e n t e d configuration c o n f i g u r a t i o n management m a n a g e m e n t control c o n t r o l before b e f o r e they t h e y are a r e VERIFIED. V E R I F I E D . [Class [ C l a s s B, B , C] C ] 5.1.12 5 . 1 . 1 2 Identification I d e n t i f i c a t i o n and a n d avoidance a v o i d a n c e of o f common c o m m o n software s o f t w a r e defects d e f e c t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n a a procedure p r o c e d u r e for: f o r : identifying i d e n t i f y i n g categories c a t e g o r i e s of o f defects d e f e c t s that t h a t may m a y be b e introduced i n t r o d u c e d based b a s e d on o n the t h e selected s e l e c t e d programming p r o g r a m m i n g technology t e c h n o l o g y that t h a t are a r e relevant r e l e v a n t to t o their t h e i r SOFTWARE S O F T W A R E SYSTEM; S Y S T E M ; and a n d documenting d o c u m e n t i n g evidence e v i d e n c e that t h a t demonstrates d e m o n s t r a t e s that t h a t these t h e s e defects d e f e c t s do d o not n o t contribute c o n t r i b u t e to t o unacceptable u n a c c e p t a b l e RISK. R I S K . NOTE N O T E See S e e Annex A n n e x B B of o f IEC I E C TR T R 80002-1:2009 8 0 0 0 2 - 1 : 2 0 0 9 for f o r examples e x a m p l e s of o f categories c a t e g o r i e s of o f defects d e f e c t s or o r causes c a u s e s contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS. S I T U A T I O N S . [Class [ C l a s s B, B , C] C ] 5.2 5 . 2 * * Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements r e q u i r e m e n t s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . For F o r each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M of o f the t h e MEDICAL M E D I C A L DEVICE, D E V I C E , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l define d e f i n e and a n d document d o c u m e n t SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s from f r o m the t h e SYSTEM S Y S T E M level l e v e l requirements. r e q u i r e m e n t s . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E There T h e r e might m i g h t not n o t be b e a a difference d i f f e r e n c e between b e t w e e n SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s if i f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a stand s t a n d alone a l o n e SYSTEM S Y S T E M (software-only ( s o f t w a r e - o n l y device). d e v i c e ) . 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t As A s appropriate a p p r o p r i a t e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e in i n the t h e software s o f t w a r e requirements: r e q u i r e m e n t s : functional f u n c t i o n a l and a n d capability c a p a b i l i t y requirements; r e q u i r e m e n t s ; NOTE N O T E 1 1 Examples E x a m p l e s include: i n c l u d e : – – performance p e r f o r m a n c e (e.g., ( e . g . , purpose p u r p o s e of o f software, s o f t w a r e , timing t i m i n g requirements), r e q u i r e m e n t s ) , – – physical p h y s i c a l characteristics c h a r a c t e r i s t i c s (e.g., ( e . g . , code c o d e language, l a n g u a g e , platform, p l a t f o r m , operating o p e r a t i n g system), s y s t e m ) , granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 22 2 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 – – computing c o m p u t i n g environment e n v i r o n m e n t (e.g., ( e . g . , hardware, h a r d w a r e , memory m e m o r y size, s i z e , processing p r o c e s s i n g unit, u n i t , time t i m e zone, z o n e , network n e t w o r k infrastructure) i n f r a s t r u c t u r e ) under u n d e r which w h i c h the t h e software s o f t w a r e is i s to t o perform, p e r f o r m , and a n d – – need n e e d for f o r compatibility c o m p a t i b i l i t y with w i t h upgrades u p g r a d e s or o r multiple m u l t i p l e SOUP S O U P or o r other o t h e r device d e v i c e versions. v e r s i o n s . SOFTWARE S O F T W A R E SYSTEM S Y S T E M inputs i n p u t s and a n d outputs; o u t p u t s ; NOTE N O T E 2 2 Examples E x a m p l e s include: i n c l u d e : – – data d a t a characteristics c h a r a c t e r i s t i c s (e.g., ( e . g . , numerical, n u m e r i c a l , alpha-numeric, a l p h a - n u m e r i c , format) f o r m a t ) – – ranges, r a n g e s , – – limits, l i m i t s , and a n d – – defaults. d e f a u l t s . interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d other o t h e r SYSTEMS; S Y S T E M S ; software-driven s o f t w a r e - d r i v e n alarms, a l a r m s , warnings, w a r n i n g s , and a n d operator o p e r a t o r messages; m e s s a g e s ; SECURITY S E C U R I T Y requirements; r e q u i r e m e n t s ; NOTE N O T E 3 3 Examples E x a m p l e s include: i n c l u d e : – – those t h o s e related r e l a t e d to t o the t h e compromise c o m p r o m i s e of o f sensitive s e n s i t i v e information, i n f o r m a t i o n , – – authentication, a u t h e n t i c a t i o n , – – authorization, a u t h o r i z a t i o n , – – audit a u d i t trail, t r a i l , and a n d – – communication c o m m u n i c a t i o n integrity, i n t e g r i t y , – – system s y s t e m security/malware s e c u r i t y / m a l w a r e protection. p r o t e c t i o n . usability u s a b i l i t y engineering e n g i n e e r i n g requirements r e q u i r e m e n t s that t h a t are a r e sensitive s e n s i t i v e to t o human h u m a n errors e r r o r s and a n d training t r a i n i n g user u s e r interface i n t e r f a c e requirements r e q u i r e m e n t s implemented i m p l e m e n t e d by b y software; s o f t w a r e ; NOTE N O T E 4 4 Examples E x a m p l e s include i n c l u d e those t h o s e related r e l a t e d to: t o : – – support s u p p o r t for f o r manual m a n u a l operations, o p e r a t i o n s , – – human-equipment h u m a n - e q u i p m e n t interactions, i n t e r a c t i o n s , – – constraints c o n s t r a i n t s on o n personnel, p e r s o n n e l , and a n d – – areas a r e a s needing n e e d i n g concentrated c o n c e n t r a t e d human h u m a n attention. a t t e n t i o n . NOTE N O T E 5 5 Information I n f o r m a t i o n regarding r e g a r d i n g usability u s a b i l i t y engineering e n g i n e e r i n g requirements r e q u i r e m e n t s can c a n be b e found f o u n d in i n IEC I E C 62366-1 6 2 3 6 6 - 1 [21] [ 2 1 ] among a m o n g others o t h e r s (e.g., ( e . g . , IEC I E C 60601-1-6 6 0 6 0 1 - 1 - 6 [3]). [ 3 ] ) . data d a t a definition d e f i n i t i o n and a n d database d a t a b a s e requirements; r e q u i r e m e n t s ; NOTE N O T E 6 6 Examples E x a m p l e s include: i n c l u d e : – – form; f o r m ; – – fit; f i t ; – – function. f u n c t i o n . installation i n s t a l l a t i o n and a n d acceptance a c c e p t a n c e requirements r e q u i r e m e n t s of o f the t h e delivered d e l i v e r e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E at a t the t h e operation o p e r a t i o n and a n d maintenance m a i n t e n a n c e site s i t e or o r sites; s i t e s ; requirements r e q u i r e m e n t s related r e l a t e d to t o methods m e t h o d s of o f operation o p e r a t i o n and a n d maintenance; m a i n t e n a n c e ; user u s e r documentation d o c u m e n t a t i o n to t o be b e developed d e v e l o p e d requirements r e q u i r e m e n t s related r e l a t e d to t o IT-network I T - n e t w o r k aspects; a s p e c t s ; NOTE N O T E 9 9 Examples E x a m p l e s include i n c l u d e those t h o s e related r e l a t e d to: t o : – – networked n e t w o r k e d alarms, a l a r m s , warnings, w a r n i n g s , and a n d operator o p e r a t o r messages; m e s s a g e s ; – – network n e t w o r k protocols; p r o t o c o l s ; – – handling h a n d l i n g of o f unavailability u n a v a i l a b i l i t y of o f network n e t w o r k services. s e r v i c e s . user u s e r maintenance m a i n t e n a n c e requirements; r e q u i r e m e n t s ; and a n d regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . NOTE N O T E 10 1 0 The T h e requirements r e q u i r e m e n t s in i n a) a ) through t h r o u g h l) l ) can c a n overlap. o v e r l a p . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 7 7 All A l l of o f these t h e s e requirements r e q u i r e m e n t s might m i g h t not n o t be b e available a v a i l a b l e at a t the t h e beginning b e g i n n i n g of o f the t h e software s o f t w a r e development. d e v e l o p m e n t . NOTE N O T E 8 8 Among A m o n g others, o t h e r s , ISO/IEC I S O / I E C 9126-1 9 1 2 6 - 1 [8] [ 8 ] ISO/IEC I S O / I E C 25010 2 5 0 1 0 [12] [ 1 2 ] provides p r o v i d e s information i n f o r m a t i o n on o n quality q u a l i t y characteristics c h a r a c t e r i s t i c s that t h a t may m a y be b e useful u s e f u l in i n defining d e f i n i n g software s o f t w a r e requirements. r e q u i r e m e n t s . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 23 2 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e for f o r hardware h a r d w a r e failures f a i l u r e s and a n d potential p o t e n t i a l software s o f t w a r e defects d e f e c t s in i n the t h e requirements r e q u i r e m e n t s as a s appropriate a p p r o p r i a t e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . [Class [ C l a s s B, B , C] C ] NOTE N O T E These T h e s e requirements r e q u i r e m e n t s might m i g h t not n o t be b e available a v a i l a b l e at a t the t h e beginning b e g i n n i n g of o f the t h e software s o f t w a r e development d e v e l o p m e n t and a n d can c a n change c h a n g e as a s the t h e software s o f t w a r e is i s designed d e s i g n e d and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s are a r e further f u r t h e r defined. d e f i n e d . 5.2.4 5 . 2 . 4 Re-EVALUATE R e - E V A L U A T E MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l re-EVALUATE r e - E V A L U A T E the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S when w h e n software s o f t w a r e requirements r e q u i r e m e n t s are a r e established e s t a b l i s h e d and a n d update u p d a t e it i t as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] 5.2.5 5 . 2 . 5 Update U p d a t e SYSTEM S Y S T E M requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t existing e x i s t i n g requirements, r e q u i r e m e n t s , including i n c l u d i n g SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , are a r e re- r e - EVALUATED E V A L U A T E D and a n d updated u p d a t e d as a s appropriate a p p r o p r i a t e as a s a a result r e s u l t of o f the t h e software s o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY. A C T I V I T Y . [Class [ C l a s s A, A , B, B , C] C ] 5.2.6 5 . 2 . 6 Verify V e r i f y software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that t h a t the t h e software s o f t w a r e requirements: r e q u i r e m e n t s : implement i m p l e m e n t SYSTEM S Y S T E M requirements r e q u i r e m e n t s including i n c l u d i n g those t h o s e relating r e l a t i n g to t o RISK R I S K CONTROL; C O N T R O L ; do d o not n o t contradict c o n t r a d i c t one o n e another; a n o t h e r ; are a r e expressed e x p r e s s e d in i n terms t e r m s that t h a t avoid a v o i d ambiguity; a m b i g u i t y ; are a r e stated s t a t e d in i n terms t e r m s that t h a t permit p e r m i t establishment e s t a b l i s h m e n t of o f test t e s t criteria c r i t e r i a and a n d performance p e r f o r m a n c e of o f tests t e s t s to t o determine d e t e r m i n e whether w h e t h e r the t h e test t e s t criteria c r i t e r i a have h a v e been b e e n met m e t ; ; can c a n be b e uniquely u n i q u e l y identified; i d e n t i f i e d ; and a n d are a r e traceable t r a c e a b l e to t o SYSTEM S Y S T E M requirements r e q u i r e m e n t s or o r other o t h e r source. s o u r c e . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e the t h e use u s e of o f a a formal f o r m a l specification s p e c i f i c a t i o n language. l a n g u a g e . 5.3 5 . 3 * * Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.1 5 . 3 . 1 Transform T r a n s f o r m software s o f t w a r e requirements r e q u i r e m e n t s into i n t o an a n ARCHITECTURE A R C H I T E C T U R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l transform t r a n s f o r m the t h e requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E into i n t o a a documented d o c u m e n t e d ARCHITECTURE A R C H I T E C T U R E that t h a t describes d e s c r i b e s the t h e software’s s o f t w a r e ’ s structure s t r u c t u r e and a n d identifies i d e n t i f i e s the t h e SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.3.2 5 . 3 . 2 Develop D e v e l o p an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s of o f SOFTWARE S O F T W A R E ITEMS I T E M S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l develop d e v e l o p and a n d document d o c u m e n t an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d the t h e components c o m p o n e n t s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E ITEMS I T E M S (both ( b o t h software s o f t w a r e and a n d hardware), h a r d w a r e ) , and a n d between b e t w e e n the t h e SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s B, B , C] C ] 5.3.3 5 . 3 . 3 Specify S p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s of o f SOUP S O U P item i t e m If I f a a SOFTWARE S O F T W A R E ITEM I T E M is i s identified i d e n t i f i e d as a s SOUP, S O U P , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l specify s p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s for f o r the t h e SOUP S O U P item i t e m that t h a t are a r e necessary n e c e s s a r y for f o r its i t s intended i n t e n d e d use. u s e . [Class [ C l a s s B, B , C] C ] 5.3.4 5 . 3 . 4 Specify S p e c i f y SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e required r e q u i r e d by b y SOUP S O U P item i t e m If I f a a SOFTWARE S O F T W A R E ITEM I T E M is i s identified i d e n t i f i e d as a s SOUP, S O U P , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l specify s p e c i f y the t h e SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e necessary n e c e s s a r y to t o support s u p p o r t the t h e proper p r o p e r operation o p e r a t i o n of o f the t h e SOUP S O U P item. i t e m . [Class [ C l a s s B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 24 2 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E Examples E x a m p l e s include i n c l u d e processor p r o c e s s o r type t y p e and a n d speed, s p e e d , memory m e m o r y type t y p e and a n d size, s i z e , SYSTEM S Y S T E M software s o f t w a r e type, t y p e , communication c o m m u n i c a t i o n and a n d display d i s p l a y software s o f t w a r e requirements. r e q u i r e m e n t s . 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y the t h e any a n y segregation s e g r e g a t i o n between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t is i s essential e s s e n t i a l to t o necessary n e c e s s a r y for f o r RISK R I S K CONTROL, C O N T R O L , and a n d state s t a t e how h o w to t o ensure e n s u r e that t h a t the t h e such s u c h segregation s e g r e g a t i o n is i s effective. e f f e c t i v e . [Class [ C l a s s C] C ] NOTE N O T E An A n example e x a m p l e of o f segregation s e g r e g a t i o n is i s to t o have h a v e SOFTWARE S O F T W A R E ITEMS I T E M S execute e x e c u t e on o n different d i f f e r e n t processors. p r o c e s s o r s . The T h e effectiveness e f f e c t i v e n e s s of o f the t h e segregation s e g r e g a t i o n can c a n be b e ensured e n s u r e d by b y having h a v i n g no n o shared s h a r e d resources r e s o u r c e s between b e t w e e n the t h e processors. p r o c e s s o r s . Other O t h e r means m e a n s of o f segregation s e g r e g a t i o n can c a n be b e applied a p p l i e d when w h e n effectiveness e f f e c t i v e n e s s can c a n be b e ensured e n s u r e d by b y the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E design d e s i g n (see ( s e e B.4.3). B . 4 . 3 ) . 5.3.6 5 . 3 . 6 Verify V e r i f y software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that: t h a t : the t h e ARCHITECTURE A R C H I T E C T U R E of o f the t h e software s o f t w a r e implements i m p l e m e n t s SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s including i n c l u d i n g those t h o s e relating r e l a t i n g to t o RISK R I S K CONTROL; C O N T R O L ; the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s able a b l e to t o support s u p p o r t interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S and a n d between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S and a n d hardware; h a r d w a r e ; and a n d the t h e MEDICAL M E D I C A L DEVICE D E V I C E ARCHITECTURE A R C H I T E C T U R E supports s u p p o r t s proper p r o p e r operation o p e r a t i o n of o f any a n y SOUP S O U P items. i t e m s . [Class [ C l a s s B, B , C] C ] NOTE N O T E A A TRACEABILITY T R A C E A B I L I T Y analysis a n a l y s i s of o f ARCHITECTURE A R C H I T E C T U R E to t o software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e used u s e d to t o satisfy s a t i s f y requirement r e q u i r e m e n t a). a ) . 5.4 5 . 4 * * Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.1 5 . 4 . 1 Refine R e f i n e SOFTWARE S O F T W A R E ARCHITECTURE A R C H I T E C T U R E Subdivide S u b d i v i d e software s o f t w a r e into i n t o SOFTWARE S O F T W A R E UNITS U N I T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l refine r e f i n e subdvide s u b d v i d e the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E until u n t i l it i t is i s represented r e p r e s e n t e d by b y SOFTWARE S O F T W A R E UNITS. U N I T S . [Class [ C l a s s B, B , C] C ] NOTE N O T E Some S o m e SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S are a r e not n o t divided d i v i d e d further. f u r t h e r . 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l develop d e v e l o p and a n d document d o c u m e n t a a detailed d e t a i l e d design d e s i g n with w i t h enough e n o u g h detail d e t a i l to t o allow a l l o w correct c o r r e c t implementation i m p l e m e n t a t i o n of o f for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T of o f the t h e SOFTWARE S O F T W A R E ITEM. I T E M . [Class [ C l a s s C] C ] 5.4.3 5 . 4 . 3 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r interfaces i n t e r f a c e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l develop d e v e l o p and a n d document d o c u m e n t a a detailed d e t a i l e d design d e s i g n for f o r any a n y interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E UNIT U N I T and a n d external e x t e r n a l components c o m p o n e n t s (hardware ( h a r d w a r e or o r software), s o f t w a r e ) , as a s well w e l l as a s any a n y interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E UNITS, U N I T S , detailed d e t a i l e d enough e n o u g h to t o implement i m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T and a n d its i t s interfaces i n t e r f a c e s correctly. c o r r e c t l y . [Class [ C l a s s C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.4.4 5 . 4 . 4 Verify V e r i f y detailed d e t a i l e d design d e s i g n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that t h a t the t h e software s o f t w a r e detailed d e t a i l e d design: d e s i g n : implements i m p l e m e n t s the t h e software s o f t w a r e ARCHITECTURE; A R C H I T E C T U R E ; and a n d is i s free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . [Class [ C l a s s C] C ] NOTE N O T E It I t is i s acceptable a c c e p t a b l e to t o use u s e a a TRACEABILITY T R A C E A B I L I T Y analysis a n a l y s i s of o f ARCHITECTURE A R C H I T E C T U R E to t o software s o f t w a r e detailed d e t a i l e d design d e s i g n to t o satisfy s a t i s f y requirement r e q u i r e m e n t a). a ) . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 25 2 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.5 5 . 5 * * SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.5.1 5 . 5 . 1 Implement I m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l implement i m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT. U N I T . [Class [ C l a s s A, A , B, B , C] C ] 5.5.2 5 . 5 . 2 Establish E s t a b l i s h SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h strategies, s t r a t e g i e s , methods m e t h o d s and a n d procedures p r o c e d u r e s for f o r verifying v e r i f y i n g each e a c h the t h e SOFTWARE S O F T W A R E UNITS. U N I T S . Where W h e r e VERIFICATION V E R I F I C A T I O N is i s done d o n e by b y testing, t e s t i n g , the t h e test t e s t procedures p r o c e d u r e s shall s h a l l be b e EVALUATED E V A L U A T E D for f o r correctness c o r r e c t n e s s adequacy. a d e q u a c y . [Class [ C l a s s B, B , C] C ] NOTE N O T E It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . 5.5.3 5 . 5 . 3 SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h acceptance a c c e p t a n c e criteria c r i t e r i a for f o r SOFTWARE S O F T W A R E UNITS U N I T S prior p r i o r to t o integration i n t e g r a t i o n into i n t o larger l a r g e r SOFTWARE S O F T W A R E ITEMS I T E M S as a s appropriate, a p p r o p r i a t e , and a n d ensure e n s u r e that t h a t SOFTWARE S O F T W A R E UNITS U N I T S meet m e e t acceptance a c c e p t a n c e criteria. c r i t e r i a . [Class [ C l a s s B, B , C] C ] NOTE N O T E Examples E x a m p l e s of o f acceptance a c c e p t a n c e criteria c r i t e r i a are: a r e : – – does d o e s the t h e software s o f t w a r e code c o d e implement i m p l e m e n t requirements r e q u i r e m e n t s including i n c l u d i n g RISK R I S K CONTROL C O N T R O L measures? m e a s u r e s ? – – is i s the t h e software s o f t w a r e code c o d e free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e interfaces i n t e r f a c e s documented d o c u m e n t e d in i n the t h e detailed d e t a i l e d design d e s i g n of o f the t h e SOFTWARE S O F T W A R E UNIT? U N I T ? – – does d o e s the t h e software s o f t w a r e code c o d e conform c o n f o r m to t o programming p r o g r a m m i n g procedures p r o c e d u r e s or o r coding c o d i n g standards? s t a n d a r d s ? 5.5.4 5 . 5 . 4 Additional A d d i t i o n a l SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a When W h e n present p r e s e n t in i n the t h e design, d e s i g n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e additional a d d i t i o n a l acceptance a c c e p t a n c e criteria c r i t e r i a as a s appropriate a p p r o p r i a t e for: f o r : proper p r o p e r event e v e n t sequence; s e q u e n c e ; data d a t a and a n d control c o n t r o l flow; f l o w ; planned p l a n n e d resource r e s o u r c e allocation; a l l o c a t i o n ; fault f a u l t handling h a n d l i n g (error ( e r r o r definition, d e f i n i t i o n , isolation, i s o l a t i o n , and a n d recovery); r e c o v e r y ) ; initialisation i n i t i a l i s a t i o n of o f variables; v a r i a b l e s ; self-diagnostics; s e l f - d i a g n o s t i c s ; memory m e m o r y management m a n a g e m e n t and a n d memory m e m o r y overflows; o v e r f l o w s ; and a n d boundary b o u n d a r y conditions. c o n d i t i o n s . [Class [ C l a s s C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.5.5 5 . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m the t h e SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N and a n d document d o c u m e n t the t h e results. r e s u l t s . [Class [ C l a s s B, B , C] C ] 5.6 5 . 6 * * Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.6.1 5 . 6 . 1 Integrate I n t e g r a t e SOFTWARE S O F T W A R E UNITS U N I T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l integrate i n t e g r a t e the t h e SOFTWARE S O F T W A R E UNITS U N I T S in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5). 5 . 1 . 5 ) . [Class [ C l a s s B, B , C] C ] 5.6.2 5 . 6 . 2 Verify V e r i f y software s o f t w a r e integration i n t e g r a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d record r e c o r d the t h e following f o l l o w i n g aspects a s p e c t s of o f the t h e software s o f t w a r e integration i n t e g r a t i o n that t h a t the t h e SOFTWARE S O F T W A R E UNITS U N I T S have h a v e been b e e n integrated i n t e g r a t e d into i n t o SOFTWARE S O F T W A R E ITEMS I T E M S and/or a n d / o r the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 26 2 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5) 5 . 1 . 5 ) and a n d retain r e t a i n records r e c o r d s of o f the t h e evidence e v i d e n c e of o f such s u c h verification. v e r i f i c a t i o n . the t h e SOFTWARE S O F T W A R E UNITS U N I T S have h a v e been b e e n integrated i n t e g r a t e d into i n t o SOFTWARE S O F T W A R E ITEMS I T E M S and a n d the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M ; ; and a n d the t h e hardware h a r d w a r e items, i t e m s , SOFTWARE S O F T W A R E ITEMS I T E M S , , and a n d support s u p p o r t for f o r manual m a n u a l operations o p e r a t i o n s (e.g., ( e . g . , human- h u m a n - equipment e q u i p m e n t interface, i n t e r f a c e , on-line o n - l i n e help h e l p menus, m e n u s , speech s p e e c h recognition, r e c o g n i t i o n , voice v o i c e control) c o n t r o l ) of o f the t h e SYSTEM S Y S T E M have h a v e been b e e n integrated i n t e g r a t e d into i n t o the t h e SYSTEM S Y S T E M . . [Class [ C l a s s B, B , C] C ] NOTE N O T E This T h i s VERIFICATION V E R I F I C A T I O N is i s only o n l y that t h a t the t h e items i t e m s have h a v e been b e e n integrated i n t e g r a t e d integration i n t e g r a t i o n has h a s been b e e n done d o n e according a c c o r d i n g to t o the t h e plan, p l a n , not n o t that t h a t they t h e y perform p e r f o r m as a s intended i n t e n d e d . . This T h i s VERIFICATION V E R I F I C A T I O N is i s most m o s t likely l i k e l y implemented i m p l e m e n t e d by b y some s o m e form f o r m of o f inspection. i n s p e c t i o n . 5.6.3 5 . 6 . 3 Test T e s t integrated i n t e g r a t e d Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l test t e s t the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS I T E M S in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5) 5 . 1 . 5 ) and a n d document d o c u m e n t the t h e results. r e s u l t s . [Class [ C l a s s B, B , C] C ] 5.6.4 5 . 6 . 4 Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g content c o n t e n t For F o r software s o f t w a r e integration i n t e g r a t i o n testing, t e s t i n g , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l address a d d r e s s whether w h e t h e r the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEM I T E M performs p e r f o r m s as a s intended. i n t e n d e d . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 Examples E x a m p l e s to t o be b e considered c o n s i d e r e d are: a r e : - - the t h e required r e q u i r e d functionality f u n c t i o n a l i t y of o f the t h e software; s o f t w a r e ; - - implementation i m p l e m e n t a t i o n of o f RISK R I S K CONTROL C O N T R O L measures; m e a s u r e s ; - - specified s p e c i f i e d timing t i m i n g and a n d other o t h e r behaviour; b e h a v i o u r ; - - specified s p e c i f i e d functioning f u n c t i o n i n g of o f internal i n t e r n a l and a n d external e x t e r n a l interfaces; i n t e r f a c e s ; and a n d - - testing t e s t i n g under u n d e r abnormal a b n o r m a l conditions c o n d i t i o n s including i n c l u d i n g foreseeable f o r e s e e a b l e misuse. m i s u s e . NOTE N O T E 2 2 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . 5.6.5 5 . 6 . 5 Verify V e r i f y EVALUATE E V A L U A T E software s o f t w a r e integration i n t e g r a t i o n test t e s t procedures p r o c e d u r e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e integration i n t e g r a t i o n test t e s t procedures p r o c e d u r e s for f o r correctness c o r r e c t n e s s adequacy. a d e q u a c y . [Class [ C l a s s B, B , C] C ] 5.6.6 5 . 6 . 6 Conduct C o n d u c t regression r e g r e s s i o n tests t e s t s When W h e n software s o f t w a r e items i t e m s are a r e integrated, i n t e g r a t e d , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l conduct c o n d u c t REGRESSION R E G R E S S I O N TESTING T E S T I N G appropriate a p p r o p r i a t e to t o demonstrate d e m o n s t r a t e that t h a t defects d e f e c t s have h a v e not n o t been b e e n introduced i n t r o d u c e d into i n t o previously p r e v i o u s l y integrated i n t e g r a t e d software. s o f t w a r e . [Class [ C l a s s B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.6.7 5 . 6 . 7 Integration I n t e g r a t i o n test t e s t record r e c o r d contents c o n t e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : document d o c u m e n t the t h e test t e s t result r e s u l t (pass/fail ( p a s s / f a i l and a n d a a list l i s t of o f ANOMALIES); A N O M A L I E S ) ; retain r e t a i n sufficient s u f f i c i e n t records r e c o r d s to t o permit p e r m i t the t h e test t e s t to t o be b e repeated; r e p e a t e d ; and a n d identify i d e n t i f y the t h e tester. t e s t e r . [Class [ C l a s s B, B , C] C ] NOTE N O T E Requirement R e q u i r e m e n t b) b ) could c o u l d be b e implemented i m p l e m e n t e d by b y retaining, r e t a i n i n g , for f o r example: e x a m p l e : - - test t e s t case c a s e specifications s p e c i f i c a t i o n s showing s h o w i n g required r e q u i r e d actions a c t i o n s and a n d expected e x p e c t e d results; r e s u l t s ; - - records r e c o r d s of o f the t h e equipment; e q u i p m e n t ; - - records r e c o r d s of o f the t h e test t e s t environment e n v i r o n m e n t (including ( i n c l u d i n g software s o f t w a r e tools) t o o l s ) used u s e d for f o r test. t e s t . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 27 2 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.6.8 5 . 6 . 8 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l enter e n t e r ANOMALIES A N O M A L I E S found f o u n d during d u r i n g software s o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g into i n t o a a software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 9. 9 . 5.7 5 . 7 * * SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 5.7.1 5 . 7 . 1 Establish E s t a b l i s h tests t e s t s for f o r software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h and a n d perform p e r f o r m a a set s e t of o f tests, t e s t s , expressed e x p r e s s e d as a s input i n p u t stimuli, s t i m u l i , expected e x p e c t e d outcomes, o u t c o m e s , pass/fail p a s s / f a i l criteria c r i t e r i a and a n d procedures, p r o c e d u r e s , for f o r conducting c o n d u c t i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , such s u c h that t h a t all a l l software s o f t w a r e requirements r e q u i r e m e n t s are a r e covered. c o v e r e d . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 1 1 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . It I t is i s also a l s o acceptable a c c e p t a b l e to t o test t e s t software s o f t w a r e requirements r e q u i r e m e n t s in i n earlier e a r l i e r phases. p h a s e s . NOTE N O T E 2 2 Not N o t only o n l y separate s e p a r a t e tests t e s t s for f o r each e a c h requirement, r e q u i r e m e n t , but b u t also a l s o tests t e s t s of o f combinations c o m b i n a t i o n s of o f requirements r e q u i r e m e n t s can c a n be b e performed, p e r f o r m e d , especially e s p e c i a l l y if i f dependencies d e p e n d e n c i e s between b e t w e e n requirements r e q u i r e m e n t s exist. e x i s t . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e adequacy a d e q u a c y of o f VERIFICATION V E R I F I C A T I O N strategies s t r a t e g i e s and a n d test t e s t procedures. p r o c e d u r e s . 5.7.2 5 . 7 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l enter e n t e r ANOMALIES A N O M A L I E S found f o u n d during d u r i n g software s o f t w a r e system s y s t e m testing t e s t i n g into i n t o a a software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . [Class [ C l a s s A, A , B, B , C] C ] 5.7.3 5 . 7 . 3 Retest R e t e s t after a f t e r changes c h a n g e s When W h e n changes c h a n g e s are a r e made m a d e during d u r i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : repeat r e p e a t tests, t e s t s , perform p e r f o r m modified m o d i f i e d tests t e s t s or o r perform p e r f o r m additional a d d i t i o n a l tests, t e s t s , as a s appropriate, a p p r o p r i a t e , to t o verify v e r i f y the t h e effectiveness e f f e c t i v e n e s s of o f the t h e change c h a n g e in i n correcting c o r r e c t i n g the t h e problem; p r o b l e m ; conduct c o n d u c t testing t e s t i n g appropriate a p p r o p r i a t e to t o demonstrate d e m o n s t r a t e that t h a t unintended u n i n t e n d e d side s i d e effects e f f e c t s have h a v e not n o t been b e e n introduced; i n t r o d u c e d ; and a n d perform p e r f o r m relevant r e l e v a n t RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S as a s defined d e f i n e d in i n 7.4. 7 . 4 . [Class [ C l a s s A, A , B, B , C] C ] 5.7.4 5 . 7 . 4 Verify V e r i f y Evaluate E v a l u a t e SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e appropriateness a p p r o p r i a t e n e s s of o f VERIFICATION V E R I F I C A T I O N strategies s t r a t e g i e s and a n d test t e s t procedures. p r o c e d u r e s . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y that: t h a t : Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . the t h e VERIFICATION V E R I F I C A T I O N strategies s t r a t e g i e s and a n d the t h e test t e s t procedures p r o c e d u r e s used u s e d are a r e appropriate; a p p r o p r i a t e ; SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t procedures p r o c e d u r e s trace t r a c e to t o software s o f t w a r e requirements; r e q u i r e m e n t s ; a) a ) all a l l software s o f t w a r e requirements r e q u i r e m e n t s have h a v e been b e e n tested t e s t e d or o r otherwise o t h e r w i s e VERIFIED; V E R I F I E D ; b) b ) the t h e TRACEABILITY T R A C E A B I L I T Y between b e t w e e n software s o f t w a r e requirements r e q u i r e m e n t s and a n d tests t e s t s or o r other o t h e r VERIFICATION V E R I F I C A T I O N is i s recorded; r e c o r d e d ; and a n d c) c ) test t e s t results r e s u l t s meet m e e t the t h e required r e q u i r e d pass/fail p a s s / f a i l criteria. c r i t e r i a . [Class [ C l a s s A, A , B, B , C] C ] 5.7.5 5 . 7 . 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t record r e c o r d contents c o n t e n t s In I n order o r d e r to t o support s u p p o r t the t h e repeatability r e p e a t a b i l i t y of o f tests, t e s t s , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document: d o c u m e n t : a a reference r e f e r e n c e to t o test t e s t case c a s e procedures p r o c e d u r e s showing s h o w i n g required r e q u i r e d actions a c t i o n s and a n d expected e x p e c t e d results; r e s u l t s ; granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} a)b) a ) b ) the t h e test t e s t result r e s u l t (pass/fail ( p a s s / f a i l and a n d a a list l i s t of o f ANOMALIES); A N O M A L I E S ) ; retain r e t a i n sufficient s u f f i c i e n t records r e c o r d s to t o permit p e r m i t the t h e test t e s t to t o be b e repeated; r e p e a t e d ; and a n d identify i d e n t i f y the t h e tester. t e s t e r . the t h e version v e r s i o n of o f software s o f t w a r e tested; t e s t e d ; relevant r e l e v a n t hardware h a r d w a r e and a n d software s o f t w a r e test t e s t configurations; c o n f i g u r a t i o n s ; relevant r e l e v a n t test t e s t tools; t o o l s ; date d a t e tested; t e s t e d ; and a n d – – 28 2 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 the t h e identity i d e n t i t y of o f the t h e person p e r s o n responsible r e s p o n s i b l e for f o r executing e x e c u t i n g the t h e test t e s t and a n d recording r e c o r d i n g the t h e test t e s t results. r e s u l t s . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Requirement R e q u i r e m e n t b) b ) could c o u l d be b e implemented i m p l e m e n t e d by b y retaining, r e t a i n i n g , for f o r example: e x a m p l e : – – test t e s t case c a s e specifications s p e c i f i c a t i o n s showing s h o w i n g required r e q u i r e d actions a c t i o n s and a n d expected e x p e c t e d results; r e s u l t s ; – – records r e c o r d s of o f the t h e equipment; e q u i p m e n t ; and a n d – – records r e c o r d s of o f the t h e test t e s t environment e n v i r o n m e n t (including ( i n c l u d i n g software s o f t w a r e tools) t o o l s ) used u s e d for f o r test. t e s t . 5.8 5 . 8 * * Software S o f t w a r e RELEASE R E L E A S E for f o r utilization u t i l i z a t i o n at a t a a SYSTEM S Y S T E M level l e v e l 5.8.1 5 . 8 . 1 Ensure E n s u r e software s o f t w a r e VERIFICATION V E R I F I C A T I O N is i s complete c o m p l e t e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l software s o f t w a r e VERIFICATION V E R I F I C A T I O N ACTIVITIES A C T I V I T I E S have h a v e been b e e n completed c o m p l e t e d and a n d the t h e results r e s u l t s have h a v e been b e e n EVALUATED E V A L U A T E D before b e f o r e the t h e software s o f t w a r e is i s released. r e l e a s e d . [Class [ C l a s s A, A , B, B , C] C ] 5.8.2 5 . 8 . 2 Document D o c u m e n t known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t all a l l known k n o w n residual r e s i d u a l ANOMALIES. A N O M A L I E S . [Class [ C l a s s A, A , B, B , C] C ] 5.8.3 5 . 8 . 3 EVALUATE E V A L U A T E known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S have h a v e been b e e n EVALUATED E V A L U A T E D to t o ensure e n s u r e that t h a t they t h e y do d o not n o t contribute c o n t r i b u t e to t o an a n unacceptable u n a c c e p t a b l e RISK. R I S K . [Class [ C l a s s B, B , C] C ] 5.8.4 5 . 8 . 4 Document D o c u m e n t released r e l e a s e d VERSIONS V E R S I O N S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T that t h a t is i s being b e i n g released. r e l e a s e d . [Class [ C l a s s A, A , B, B , C] C ] 5.8.5 5 . 8 . 5 Document D o c u m e n t how h o w released r e l e a s e d software s o f t w a r e was w a s created c r e a t e d The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e procedure p r o c e d u r e and a n d environment e n v i r o n m e n t used u s e d to t o create c r e a t e the t h e released r e l e a s e d software. s o f t w a r e . [Class [ C l a s s B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.8.6 5 . 8 . 6 Ensure E n s u r e activities a c t i v i t i e s and a n d tasks t a s k s are a r e complete c o m p l e t e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l software s o f t w a r e development d e v e l o p m e n t plan p l a n (or ( o r maintenance m a i n t e n a n c e plan) p l a n ) ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S are a r e complete c o m p l e t e along a l o n g with w i t h all a l l the t h e associated a s s o c i a t e d documentation. d o c u m e n t a t i o n . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e 5.1.3.b). 5 . 1 . 3 . b ) . 5.8.7 5 . 8 . 7 Archive A r c h i v e software s o f t w a r e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l archive: a r c h i v e : the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T and a n d CONFIGURATION C O N F I G U R A T I O N ITEMS; I T E M S ; and a n d the t h e documentation d o c u m e n t a t i o n granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 29 2 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 for f o r at a t least l e a s t a a period p e r i o d of o f time t i m e determined d e t e r m i n e d as a s the t h e longer l o n g e r of: o f : the t h e life l i f e time t i m e of o f the t h e device d e v i c e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E as a s defined d e f i n e d by b y the t h e MANUFACTURER M A N U F A C T U R E R or o r a a time t i m e specified s p e c i f i e d by b y relevant r e l e v a n t regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . [Class [ C l a s s A, A , B, B , C] C ] 5.8.8 5 . 8 . 8 Assure A s s u r e repeatability r e p e a t a b i l i t y of o f software s o f t w a r e release r e l e a s e reliable r e l i a b l e delivery d e l i v e r y of o f released r e l e a s e d software s o f t w a r e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h procedures p r o c e d u r e s to t o ensure e n s u r e that t h a t the t h e released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T can c a n be b e reliably r e l i a b l y delivered d e l i v e r e d to t o the t h e point p o i n t of o f use u s e without w i t h o u t corruption c o r r u p t i o n or o r unauthorised u n a u t h o r i s e d change. c h a n g e . These T h e s e procedures p r o c e d u r e s shall s h a l l address a d d r e s s the t h e production p r o d u c t i o n and a n d handling h a n d l i n g of o f media m e d i a containing c o n t a i n i n g the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T including i n c l u d i n g as a s appropriate: a p p r o p r i a t e : – – replication, r e p l i c a t i o n , – – media m e d i a labelling, l a b e l l i n g , – – packaging, p a c k a g i n g , – – protection, p r o t e c t i o n , – – storage, s t o r a g e , and a n d – – delivery. d e l i v e r y . [Class [ C l a s s A, A , B, B , C] C ] 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S 6.1 6 . 1 * * Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n (or ( o r plans) p l a n s ) for f o r conducting c o n d u c t i n g the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e maintenance m a i n t e n a n c e PROCESS. P R O C E S S . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e following: f o l l o w i n g : procedures p r o c e d u r e s for: f o r : – – receiving, r e c e i v i n g , – – documenting, d o c u m e n t i n g , – – evaluating, e v a l u a t i n g , – – resolving r e s o l v i n g and a n d – – tracking t r a c k i n g feedback f e e d b a c k arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE; S O F T W A R E ; criteria c r i t e r i a for f o r determining d e t e r m i n i n g whether w h e t h e r feedback f e e d b a c k is i s considered c o n s i d e r e d to t o be b e a a problem; p r o b l e m ; use u s e of o f the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS; P R O C E S S ; use u s e of o f the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S for f o r analysing a n a l y s i n g and a n d resolving r e s o l v i n g problems p r o b l e m s arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE; S O F T W A R E ; use u s e of o f the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) for f o r managing m a n a g i n g modifications m o d i f i c a t i o n s to t o the t h e existing e x i s t i n g SOFTWARE S O F T W A R E SYSTEM; S Y S T E M ; and a n d procedures p r o c e d u r e s to t o EVALUATE E V A L U A T E and a n d implement: i m p l e m e n t : – – upgrades, u p g r a d e s , – – bug b u g fixes, f i x e s , – – patches p a t c h e s and a n d – – obsolescence o b s o l e s c e n c e of o f SOUP. S O U P . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 6.2 6 . 2 * * Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s – – 30 3 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 6.2.1 6 . 2 . 1 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k 6.2.1.1 6 . 2 . 1 . 1 Monitor M o n i t o r feedback f e e d b a c k The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l monitor m o n i t o r feedback f e e d b a c k on o n released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T from f r o m both b o t h inside i n s i d e its i t s own o w n organization o r g a n i z a t i o n and a n d from f r o m users u s e r s released r e l e a s e d for f o r intended i n t e n d e d use. u s e . [Class [ C l a s s A, A , B, B , C] C ] 6.2.1.2 6 . 2 . 1 . 2 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k Feedback F e e d b a c k shall s h a l l be b e documented d o c u m e n t e d and a n d EVALUATED E V A L U A T E D to t o determine d e t e r m i n e whether w h e t h e r a a problem p r o b l e m exists e x i s t s in i n a a released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T . . Any A n y such s u c h problem p r o b l e m shall s h a l l be b e recorded r e c o r d e d as a s a a PROBLEM P R O B L E M REPORT R E P O R T (see ( s e e Clause C l a u s e 9). 9 ) . PROBLEM P R O B L E M REPORTS R E P O R T S shall s h a l l include i n c l u d e actual a c t u a l or o r potential p o t e n t i a l adverse a d v e r s e events, e v e n t s , and a n d deviations d e v i a t i o n s from f r o m specifications. s p e c i f i c a t i o n s . [Class [ C l a s s A, A , B, B , C] C ] 6.2.1.3 6 . 2 . 1 . 3 Evaluate E v a l u a t e PROBLEM P R O B L E M REPORT’S R E P O R T ’ S affects a f f e c t s on o n SAFETY S A F E T Y Each E a c h PROBLEM P R O B L E M REPORT R E P O R T shall s h a l l be b e EVALUATED E V A L U A T E D to t o determine d e t e r m i n e how h o w it i t affects a f f e c t s the t h e SAFETY S A F E T Y of o f a a released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T released r e l e a s e d for f o r intended i n t e n d e d use u s e (see ( s e e 9.2) 9 . 2 ) and a n d whether w h e t h e r a a change c h a n g e to t o the t h e released r e l e a s e d that t h a t software s o f t w a r e PRODUCT P R O D U C T is i s needed n e e d e d to t o address a d d r e s s the t h e problem. p r o b l e m . [Class [ C l a s s A, A , B, B , C] C ] 6.2.2 6 . 2 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S (see ( s e e Clause C l a u s e 9) 9 ) to t o address a d d r e s s PROBLEM P R O B L E M REPORTS. R E P O R T S . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E A A problem p r o b l e m could c o u l d show s h o w that t h a t a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r SOFTWARE S O F T W A R E ITEM I T E M has h a s not n o t been b e e n placed p l a c e d in i n the t h e correct c o r r e c t software s o f t w a r e safety s a f e t y class. c l a s s . The T h e problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s can c a n suggest s u g g e s t changes c h a n g e s of o f the t h e software s o f t w a r e safety s a f e t y class. c l a s s . When W h e n this t h i s ACTIVITY A C T I V I T Y has h a s been b e e n done d o n e the t h e PROCESS P R O C E S S has h a s been b e e n completed, c o m p l e t e d , any a n y change c h a n g e of o f safety s a f e t y class c l a s s in i n the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r its i t s SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e made m a d e known k n o w n and a n d documented. d o c u m e n t e d . 6.2.3 6 . 2 . 3 Analyse A n a l y s e CHANGE C H A N G E REQUESTS R E Q U E S T S In I n addition a d d i t i o n to t o the t h e analysis a n a l y s i s required r e q u i r e d by b y Clause C l a u s e 9, 9 , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e each e a c h CHANGE C H A N G E REQUEST R E Q U E S T for f o r its i t s effect e f f e c t on o n the t h e organization, o r g a n i z a t i o n , released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S released r e l e a s e d for f o r intended i n t e n d e d use u s e , , and a n d SYSTEMS S Y S T E M S with w i t h which w h i c h it i t interfaces. i n t e r f a c e s . [Class [ C l a s s A, A , B, B , C] C ] 6.2.4 6 . 2 . 4 CHANGE C H A N G E REQUEST R E Q U E S T approval a p p r o v a l The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E and a n d approve a p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S which w h i c h modify m o d i f y released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S . . [Class [ C l a s s A, A , B, B , C] C ] 6.2.5 6 . 2 . 5 Communicate C o m m u n i c a t e to t o users u s e r s and a n d regulators r e g u l a t o r s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y the t h e approved a p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S that t h a t affect a f f e c t released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS. P R O D U C T S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . As A s required r e q u i r e d by b y local l o c a l regulation, r e g u l a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l inform i n f o r m users u s e r s and a n d regulators r e g u l a t o r s about: a b o u t : any a n y problem p r o b l e m in i n released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S and a n d the t h e consequences c o n s e q u e n c e s of o f continued c o n t i n u e d unchanged u n c h a n g e d use; u s e ; and a n d the t h e nature n a t u r e of o f any a n y available a v a i l a b l e changes c h a n g e s to t o released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S and a n d how h o w to t o obtain o b t a i n and a n d install i n s t a l l the t h e changes. c h a n g e s . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 31 3 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 6.3 6 . 3 * * Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.3.1 6 . 3 . 1 Use U s e established e s t a b l i s h e d PROCESS P R O C E S S to t o implement i m p l e m e n t modification m o d i f i c a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S (see ( s e e Clause C l a u s e 5) 5 ) or o r an a n established e s t a b l i s h e d maintenance m a i n t e n a n c e PROCESS P R O C E S S to t o implement i m p l e m e n t the t h e modifications m o d i f i c a t i o n s identify i d e n t i f y and a n d perform p e r f o r m any a n y Clause C l a u s e 5 5 ACTIVITIES A C T I V I T I E S that t h a t need n e e d to t o be b e repeated r e p e a t e d as a s a a result r e s u l t of o f the t h e modification. m o d i f i c a t i o n . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E For F o r requirements r e q u i r e m e n t s relating r e l a t i n g to t o RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s see s e e 7.4. 7 . 4 . 6.3.2 6 . 3 . 2 Re-release R e - r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEM S Y S T E M The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l release r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S modifications m o d i f i c a t i o n s according a c c o r d i n g to t o 5.8. 5 . 8 . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Modifications M o d i f i c a t i o n s may m a y can c a n be b e released r e l e a s e d as a s part p a r t of o f a a full f u l l re-release r e - r e l e a s e of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r as a s a a modification m o d i f i c a t i o n kit k i t comprising c o m p r i s i n g changed c h a n g e d SOFTWARE S O F T W A R E ITEMS I T E M S and a n d the t h e necessary n e c e s s a r y tools t o o l s to t o install i n s t a l l the t h e changes c h a n g e s as a s modifications m o d i f i c a t i o n s to t o an a n existing e x i s t i n g SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . 7 7 * * Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 7.1 7 . 1 * * Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s 7.1.1 7 . 1 . 1 Identify I d e n t i f y SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t could c o u l d contribute c o n t r i b u t e to t o a a hazardous h a z a r d o u s situation s i t u a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t could c o u l d contribute c o n t r i b u t e to t o a a hazardous h a z a r d o u s situation s i t u a t i o n identified i d e n t i f i e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S ACTIVITY A C T I V I T Y of o f ISO I S O 14971 1 4 9 7 1 (see ( s e e 4.2). 4 . 2 ) . [Class [ C l a s s B, B , C] C ] NOTE N O T E The T h e hazardous h a z a r d o u s situation s i t u a t i o n could c o u l d be b e the t h e direct d i r e c t result r e s u l t of o f software s o f t w a r e failure f a i l u r e or o r the t h e result r e s u l t of o f the t h e failure f a i l u r e of o f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e that t h a t is i s implemented i m p l e m e n t e d in i n software. s o f t w a r e . 7.1.2 7 . 1 . 2 Identify I d e n t i f y potential p o t e n t i a l causes c a u s e s of o f contribution c o n t r i b u t i o n to t o a a hazardous h a z a r d o u s situation s i t u a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y potential p o t e n t i a l causes c a u s e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M identified i d e n t i f i e d above a b o v e contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation. s i t u a t i o n . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l consider c o n s i d e r potential p o t e n t i a l causes c a u s e s including, i n c l u d i n g , as a s appropriate: a p p r o p r i a t e : incorrect i n c o r r e c t or o r incomplete i n c o m p l e t e specification s p e c i f i c a t i o n of o f functionality; f u n c t i o n a l i t y ; software s o f t w a r e defects d e f e c t s in i n the t h e identified i d e n t i f i e d SOFTWARE S O F T W A R E ITEM I T E M functionality; f u n c t i o n a l i t y ; failure f a i l u r e or o r unexpected u n e x p e c t e d results r e s u l t s from f r o m SOUP; S O U P ; hardware h a r d w a r e failures f a i l u r e s or o r other o t h e r software s o f t w a r e defects d e f e c t s that t h a t could c o u l d result r e s u l t in i n unpredictable u n p r e d i c t a b l e software s o f t w a r e operation; o p e r a t i o n ; and a n d reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e misuse. m i s u s e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s B, B , C] C ] 7.1.3 7 . 1 . 3 EVALUATE E V A L U A T E published p u b l i s h e d SOUP S O U P ANOMALY A N O M A L Y lists l i s t s If I f failure f a i l u r e or o r unexpected u n e x p e c t e d results r e s u l t s from f r o m SOUP S O U P is i s a a potential p o t e n t i a l cause c a u s e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation, s i t u a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E as a s a a minimum m i n i m u m any a n y ANOMALY A N O M A L Y list l i s t published p u b l i s h e d by b y the t h e supplier s u p p l i e r of o f the t h e SOUP S O U P item i t e m relevant r e l e v a n t to t o the t h e VERSION V E R S I O N of o f the t h e SOUP S O U P item i t e m used u s e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E to t o determine d e t e r m i n e if i f any a n y of o f the t h e known k n o w n ANOMALIES A N O M A L I E S result r e s u l t in i n a a sequence s e q u e n c e of o f events e v e n t s that t h a t could c o u l d result r e s u l t in i n a a hazardous h a z a r d o u s situation. s i t u a t i o n . [Class [ C l a s s B, B , C] C ] 7.1.4 7 . 1 . 4 Document D o c u m e n t potential p o t e n t i a l causes c a u s e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E potential p o t e n t i a l causes c a u s e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation s i t u a t i o n (see ( s e e ISO I S O 14971). 1 4 9 7 1 ) . [Class [ C l a s s B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 7.1.5 7 . 1 . 5 Document D o c u m e n t sequences s e q u e n c e s of o f events e v e n t s – – 32 3 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E sequences s e q u e n c e s of o f events e v e n t s that t h a t could c o u l d result r e s u l t in i n a a hazardous h a z a r d o u s situation s i t u a t i o n that t h a t are a r e identified i d e n t i f i e d in i n 7.1.2. 7 . 1 . 2 . [Class [ C l a s s B, B , C] C ] 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.2.1 7 . 2 . 1 Define D e f i n e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s For F o r each e a c h potential p o t e n t i a l cause c a u s e of o f the t h e software s o f t w a r e item i t e m contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation s i t u a t i o n case c a s e documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E where w h e r e a a SOFTWARE S O F T W A R E ITEM I T E M could c o u l d contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l define d e f i n e and a n d document d o c u m e n t RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n accordance a c c o r d a n c e with w i t h ISO I S O 14971. 1 4 9 7 1 . [Class [ C l a s s B, B , C] C ] NOTE N O T E The T h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s can c a n be b e implemented i m p l e m e n t e d in i n hardware, h a r d w a r e , software, s o f t w a r e , the t h e working w o r k i n g environment e n v i r o n m e n t or o r user u s e r instruction. i n s t r u c t i o n . 7.2.2 7 . 2 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e If I f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s implemented i m p l e m e n t e d as a s part p a r t of o f the t h e functions f u n c t i o n s of o f a a SOFTWARE S O F T W A R E ITEM, I T E M , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : include i n c l u d e the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e in i n the t h e software s o f t w a r e requirements; r e q u i r e m e n t s ; assign a s s i g n a a software s o f t w a r e safety s a f e t y class c l a s s to t o the t h e to t o each e a c h SOFTWARE S O F T W A R E ITEM I T E M based b a s e d on o n the t h e possible p o s s i b l e effects e f f e c t s of o f the t h e HAZARD H A Z A R D that t h a t contributes c o n t r i b u t e s to t o the t h e implementation i m p l e m e n t a t i o n of o f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e a a software s o f t w a r e safety s a f e t y class c l a s s based b a s e d on o n the t h e RISK R I S K that t h a t the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s controlling c o n t r o l l i n g (see ( s e e 4.3 4 . 3 a)); a ) ) ; and a n d develop d e v e l o p the t h e SOFTWARE S O F T W A R E ITEM I T E M in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 5. 5 . [Class [ C l a s s B, B , C] C ] NOTE N O T E This T h i s requirement r e q u i r e m e n t provides p r o v i d e s additional a d d i t i o n a l detail d e t a i l for f o r RISK R I S K CONTROL C O N T R O L requirements r e q u i r e m e n t s of o f ISO I S O 14971 1 4 9 7 1 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.3.1 7 . 3 . 1 Verify V e r i f y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s The T h e implementation i m p l e m e n t a t i o n of o f each e a c h RISK R I S K CONTROL C O N T R O L measure m e a s u r e documented d o c u m e n t e d in i n 7.2 7 . 2 shall s h a l l be b e VERIFIED, V E R I F I E D , and a n d this t h i s VERIFICATION V E R I F I C A T I O N shall s h a l l be b e documented. d o c u m e n t e d . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l review r e v i e w the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e and a n d determine d e t e r m i n e if i f it i t could c o u l d result r e s u l t in i n a a new n e w HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . [Class [ C l a s s B, B , C] C ] 7.3.2 7 . 3 . 2 Document D o c u m e n t any a n y new n e w sequences s e q u e n c e s of o f events e v e n t s If I f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s implemented i m p l e m e n t e d as a s a a SOFTWARE S O F T W A R E ITEM I T E M , , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e to t o identify i d e n t i f y and a n d document d o c u m e n t in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E any a n y new n e w sequences s e q u e n c e s of o f events e v e n t s that t h a t could c o u l d result r e s u l t in i n a a hazardous h a z a r d o u s situation. s i t u a t i o n . [Class [ C l a s s B, B , C] C ] Not N o t used. u s e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 7.3.3 7 . 3 . 3 Document D o c u m e n t TRACEABILITY T R A C E A B I L I T Y The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t TRACEABILITY T R A C E A B I L I T Y of o f software s o f t w a r e HAZARDS H A Z A R D S as a s appropriate: a p p r o p r i a t e : from f r o m the t h e hazardous h a z a r d o u s situation s i t u a t i o n to t o the t h e SOFTWARE S O F T W A R E ITEM; I T E M ; from f r o m the t h e SOFTWARE S O F T W A R E ITEM I T E M to t o the t h e specific s p e c i f i c software s o f t w a r e cause; c a u s e ; from f r o m the t h e software s o f t w a r e cause c a u s e to t o the t h e RISK R I S K CONTROL C O N T R O L measure; m e a s u r e ; and a n d from f r o m the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e to t o the t h e VERIFICATION V E R I F I C A T I O N of o f the t h e RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e ISO I S O 14971 1 4 9 7 1 – – RISK R I S K MANAGEMENT M A N A G E M E N T report. r e p o r t . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 33 3 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s 7.4.1 7 . 4 . 1 Analyse A n a l y s e changes c h a n g e s to t o MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E with w i t h respect r e s p e c t to t o SAFETY S A F E T Y The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e changes c h a n g e s to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E (including ( i n c l u d i n g SOUP) S O U P ) to t o determine d e t e r m i n e whether: w h e t h e r : additional a d d i t i o n a l potential p o t e n t i a l causes c a u s e s are a r e introduced i n t r o d u c e d contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation; s i t u a t i o n ; and a n d additional a d d i t i o n a l software s o f t w a r e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s are a r e required. r e q u i r e d . [Class [ C l a s s A, A , B, B , C] C ] 7.4.2 7 . 4 . 2 Analyse A n a l y s e impact i m p a c t of o f software s o f t w a r e changes c h a n g e s on o n existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e changes c h a n g e s to t o the t h e software, s o f t w a r e , including i n c l u d i n g changes c h a n g e s to t o SOUP, S O U P , to t o determine d e t e r m i n e whether w h e t h e r the t h e software s o f t w a r e modification m o d i f i c a t i o n could c o u l d interfere i n t e r f e r e with w i t h existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . [Class [ C l a s s B, B , C] C ] 7.4.3 7 . 4 . 3 Perform P e r f o r m RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S based b a s e d on o n analyses a n a l y s e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m relevant r e l e v a n t RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n 7.1, 7 . 1 , 7.2 7 . 2 and a n d 7.3 7 . 3 based b a s e d on o n these t h e s e analyses. a n a l y s e s . [Class [ C l a s s B, B , C] C ] 8 8 * * Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S 8.1 8 . 1 * * Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 8.1.1 8 . 1 . 1 Establish E s t a b l i s h means m e a n s to t o identify i d e n t i f y CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a scheme s c h e m e for f o r the t h e unique u n i q u e identification i d e n t i f i c a t i o n of o f CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS V E R S I O N S to t o be b e controlled c o n t r o l l e d for f o r the t h e project p r o j e c t according a c c o r d i n g to t o the t h e development d e v e l o p m e n t and a n d configuration c o n f i g u r a t i o n planning p l a n n i n g specified s p e c i f i e d in i n 5.1. 5 . 1 . This T h i s scheme s c h e m e shall s h a l l include i n c l u d e other o t h e r SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S or o r entities e n t i t i e s such s u c h as a s SOUP S O U P and a n d documentation. d o c u m e n t a t i o n . [Class [ C l a s s A, A , B, B , C] C ] 8.1.2 8 . 1 . 2 Identify I d e n t i f y SOUP S O U P For F o r each e a c h SOUP S O U P CONFIGURATION C O N F I G U R A T I O N ITEM I T E M being b e i n g used, u s e d , including i n c l u d i n g standard s t a n d a r d libraries, l i b r a r i e s , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document: d o c u m e n t : the t h e title, t i t l e , the t h e MANUFACTURER, M A N U F A C T U R E R , and a n d the t h e unique u n i q u e SOUP S O U P designator d e s i g n a t o r of o f each e a c h SOUP S O U P CONFIGURATION C O N F I G U R A T I O N ITEM I T E M being b e i n g used. u s e d . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E The T h e unique u n i q u e SOUP S O U P designator d e s i g n a t o r could c o u l d be, b e , for f o r example, e x a m p l e , a a VERSION, V E R S I O N , a a release r e l e a s e date, d a t e , a a patch p a t c h number n u m b e r or o r an a n upgrade u p g r a d e designation. d e s i g n a t i o n . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 8.1.3 8 . 1 . 3 Identify I d e n t i f y SYSTEM S Y S T E M configuration c o n f i g u r a t i o n documentation d o c u m e n t a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e set s e t of o f CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS V E R S I O N S that t h a t comprise c o m p r i s e the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M configuration. c o n f i g u r a t i o n . [Class [ C l a s s A, A , B, B , C] C ] 8.2 8 . 2 * * Change C h a n g e control c o n t r o l 8.2.1 8 . 2 . 1 Approve A p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l change c h a n g e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S identified i d e n t i f i e d to t o be b e controlled c o n t r o l l e d according a c c o r d i n g to t o 8.1 8 . 1 only o n l y in i n response r e s p o n s e to t o an a n approved a p p r o v e d CHANGE C H A N G E REQUEST. R E Q U E S T . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 34 3 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E 1 1 The T h e decision d e c i s i o n to t o approve a p p r o v e a a CHANGE C H A N G E REQUEST R E Q U E S T can c a n be b e integral i n t e g r a l to t o the t h e change c h a n g e control c o n t r o l PROCESS P R O C E S S or o r part p a r t of o f another a n o t h e r PROCESS. P R O C E S S . This T h i s subclause s u b c l a u s e only o n l y requires r e q u i r e s that t h a t approval a p p r o v a l of o f a a change c h a n g e precede p r e c e d e its i t s implementation. i m p l e m e n t a t i o n . NOTE N O T E 2 2 Different D i f f e r e n t acceptance a c c e p t a n c e PROCESSES P R O C E S S E S can c a n be b e used u s e d for f o r CHANGE C H A N G E REQUESTS R E Q U E S T S at a t different d i f f e r e n t stages s t a g e s of o f the t h e life l i f e cycle, c y c l e , as a s stated s t a t e d in i n plans, p l a n s , see s e e 5.1.1 5 . 1 . 1 e) e ) d) d ) and a n d 6.1 6 . 1 e). e ) . 8.2.2 8 . 2 . 2 Implement I m p l e m e n t changes c h a n g e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l implement i m p l e m e n t the t h e change c h a n g e as a s specified s p e c i f i e d in i n the t h e CHANGE C H A N G E REQUEST. R E Q U E S T . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y and a n d perform p e r f o r m any a n y ACTIVITY A C T I V I T Y that t h a t needs n e e d s to t o be b e repeated r e p e a t e d as a s a a result r e s u l t of o f the t h e change, c h a n g e , including i n c l u d i n g changes c h a n g e s to t o the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S and a n d SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s subclause s u b c l a u s e states s t a t e s how h o w the t h e change c h a n g e should s h o u l d be b e implemented i m p l e m e n t e d to t o achieve a c h i e v e adequate a d e q u a t e change c h a n g e control. c o n t r o l . It I t does d o e s not n o t imply i m p l y that t h a t the t h e implementation i m p l e m e n t a t i o n is i s an a n integral i n t e g r a l part p a r t of o f the t h e change c h a n g e control c o n t r o l PROCESS. P R O C E S S . Implementation I m p l e m e n t a t i o n should s h o u l d use u s e planned p l a n n e d PROCESSES, P R O C E S S E S , see s e e 5.1.1 5 . 1 . 1 e) e ) and a n d 6.1 6 . 1 e). e ) . 8.2.3 8 . 2 . 3 Verify V e r i f y changes c h a n g e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y the t h e change, c h a n g e , including i n c l u d i n g repeating r e p e a t i n g any a n y VERIFICATION V E R I F I C A T I O N that t h a t has h a s been b e e n invalidated i n v a l i d a t e d by b y the t h e change c h a n g e and a n d taking t a k i n g into i n t o account a c c o u n t 5.7.3 5 . 7 . 3 and a n d 9.7. 9 . 7 . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s subclause s u b c l a u s e only o n l y requires r e q u i r e s that t h a t changes c h a n g e s be b e VERIFIED. V E R I F I E D . It I t does d o e s not n o t imply i m p l y that t h a t VERIFICATION V E R I F I C A T I O N is i s an a n integral i n t e g r a l part p a r t of o f the t h e change c h a n g e control c o n t r o l PROCESS. P R O C E S S . VERIFICATION V E R I F I C A T I O N should s h o u l d use u s e planned p l a n n e d PROCESSES, P R O C E S S E S , see s e e 5.1.1 5 . 1 . 1 e) e ) and a n d 6.1 6 . 1 e). e ) . 8.2.4 8 . 2 . 4 Provide P r o v i d e means m e a n s for f o r TRACEABILITY T R A C E A B I L I T Y of o f change c h a n g e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l create c r e a t e an a n audit a u d i t trail t r a i l whereby w h e r e b y each e a c h maintain m a i n t a i n records r e c o r d s of o f the t h e relationships r e l a t i o n s h i p s and a n d dependencies d e p e n d e n c i e s between: b e t w e e n : a) a ) CHANGE C H A N G E REQUEST; R E Q U E S T ; relevant r e l e v a n t PROBLEM P R O B L E M REPORT; R E P O R T ; and a n d approval a p p r o v a l of o f the t h e CHANGE C H A N G E REQUEST R E Q U E S T can c a n be b e traced. t r a c e d . [Class [ C l a s s A, A , B, B , C] C ] 8.3 8 . 3 * * Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l retain r e t a i n retrievable r e t r i e v a b l e records r e c o r d s of o f the t h e history h i s t o r y of o f controlled c o n t r o l l e d CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S including i n c l u d i n g SYSTEM S Y S T E M configuration. c o n f i g u r a t i o n . [Class [ C l a s s A, A , B, B , C] C ] 9 9 * * Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l prepare p r e p a r e a a PROBLEM P R O B L E M REPORT R E P O R T for f o r each e a c h problem p r o b l e m detected d e t e c t e d in i n a a the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T . . PROBLEM P R O B L E M REPORTS R E P O R T S shall s h a l l be b e classified c l a s s i f i e d as a s follows: f o l l o w s : include i n c l u d e a a statement s t a t e m e n t of o f criticality c r i t i c a l i t y (for ( f o r example, e x a m p l e , effect e f f e c t on o n performance, p e r f o r m a n c e , SAFETY, S A F E T Y , or o r SECURITY) S E C U R I T Y ) as a s well w e l l as a s other o t h e r information i n f o r m a t i o n that t h a t may m a y aid a i d in i n the t h e resolution r e s o l u t i o n of o f the t h e problem p r o b l e m (for ( f o r example, e x a m p l e , devices d e v i c e s affected, a f f e c t e d , supported s u p p o r t e d accessories a c c e s s o r i e s affected). a f f e c t e d ) . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . type; t y p e ; EXAMPLE E X A M P L E 1 1 corrective, c o r r e c t i v e , preventive, p r e v e n t i v e , or o r adaptive a d a p t i v e to t o new n e w environment e n v i r o n m e n t scope; s c o p e ; and a n d EXAMPLE E X A M P L E 2 2 size s i z e of o f change, c h a n g e , number n u m b e r of o f device d e v i c e models m o d e l s affected, a f f e c t e d , supported s u p p o r t e d accessories a c c e s s o r i e s affected, a f f e c t e d , resources r e s o u r c e s involved, i n v o l v e d , time t i m e to t o change c h a n g e criticality. c r i t i c a l i t y . EXAMPLE E X A M P L E 3 3 effect e f f e c t on o n performance, p e r f o r m a n c e , SAFETY, S A F E T Y , or o r SECURITY S E C U R I T Y [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Problems P r o b l e m s can c a n be b e discovered d i s c o v e r e d before b e f o r e or o r after a f t e r release, r e l e a s e , inside i n s i d e the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S organization o r g a n i z a t i o n or o r outside o u t s i d e it. i t . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 35 3 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem p r o b l e m The T h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : investigate i n v e s t i g a t e the t h e problem p r o b l e m and a n d if i f possible p o s s i b l e identify i d e n t i f y the t h e causes; c a u s e s ; EVALUATE E V A L U A T E the t h e problem’s p r o b l e m ’ s relevance r e l e v a n c e to t o SAFETY S A F E T Y using u s i n g the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S (Clause ( C l a u s e 7); 7 ) ; document d o c u m e n t the t h e outcome o u t c o m e of o f the t h e investigation i n v e s t i g a t i o n and a n d evaluation; e v a l u a t i o n ; and a n d create c r e a t e a a CHANGE C H A N G E REQUEST(S) R E Q U E S T ( S ) for f o r actions a c t i o n s needed n e e d e d to t o correct c o r r e c t the t h e problem, p r o b l e m , or o r document d o c u m e n t the t h e rationale r a t i o n a l e for f o r taking t a k i n g no n o action. a c t i o n . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E A A problem p r o b l e m does d o e s not n o t have h a v e to t o be b e corrected c o r r e c t e d for f o r the t h e MANUFACTURER M A N U F A C T U R E R to t o comply c o m p l y with w i t h the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS, P R O C E S S , provided p r o v i d e d that t h a t the t h e problem p r o b l e m is i s not n o t relevant r e l e v a n t to t o SAFETY. S A F E T Y . 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties p a r t i e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l advise a d v i s e relevant r e l e v a n t parties p a r t i e s of o f the t h e existence e x i s t e n c e of o f the t h e problem, p r o b l e m , as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Problems P r o b l e m s can c a n be b e discovered d i s c o v e r e d before b e f o r e or o r after a f t e r release, r e l e a s e , inside i n s i d e the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S organisation o r g a n i s a t i o n or o r outside o u t s i d e it. i t . The T h e MANUFACTURER M A N U F A C T U R E R determines d e t e r m i n e s the t h e relevant r e l e v a n t parties p a r t i e s depending d e p e n d i n g on o n the t h e situation. s i t u a t i o n . 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process p r o c e s s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l approve a p p r o v e and a n d implement i m p l e m e n t all a l l CHANGE C H A N G E REQUESTS, R E Q U E S T S , observing o b s e r v i n g the t h e requirements r e q u i r e m e n t s of o f the t h e change c h a n g e control c o n t r o l PROCESS P R O C E S S (see ( s e e 8.2). 8 . 2 ) . [Class [ C l a s s A, A , B, B , C] C ] 9.5 9 . 5 Maintain M a i n t a i n records r e c o r d s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l maintain m a i n t a i n records r e c o r d s of o f PROBLEM P R O B L E M REPORTS R E P O R T S and a n d their t h e i r resolution r e s o l u t i o n including i n c l u d i n g their t h e i r VERIFICATION. V E R I F I C A T I O N . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l update u p d a t e the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E as a s appropriate a p p r o p r i a t e (see ( s e e 7.4) 7 . 4 ) . . [Class [ C l a s s A, A , B, B , C] C ] 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends t r e n d s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m analysis a n a l y s i s to t o detect d e t e c t trends t r e n d s in i n PROBLEM P R O B L E M REPORTS. R E P O R T S . [Class [ C l a s s A, A , B, B , C] C ] 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y resolutions r e s o l u t i o n s to t o determine d e t e r m i n e whether: w h e t h e r : problem p r o b l e m has h a s been b e e n resolved r e s o l v e d and a n d the t h e PROBLEM P R O B L E M REPORT R E P O R T has h a s been b e e n closed; c l o s e d ; adverse a d v e r s e trends t r e n d s have h a v e been b e e n reversed; r e v e r s e d ; CHANGE C H A N G E REQUESTS R E Q U E S T S have h a v e been b e e n implemented i m p l e m e n t e d in i n the t h e appropriate a p p r o p r i a t e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S and a n d ACTIVITIES; A C T I V I T I E S ; and a n d additional a d d i t i o n a l problems p r o b l e m s have h a v e been b e e n introduced. i n t r o d u c e d . [Class [ C l a s s A, A , B, B , C] C ] 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents c o n t e n t s When W h e n testing, t e s t i n g , retesting r e t e s t i n g or o r REGRESSION R E G R E S S I O N TESTING T E S T I N G SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SYSTEMS S Y S T E M S following f o l l o w i n g a a change, c h a n g e , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e in i n the t h e test t e s t documentation: d o c u m e n t a t i o n : test t e s t results; r e s u l t s ; granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . b) b ) c) c ) d) d ) e) e ) f) f ) – – 36 3 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ANOMALIES A N O M A L I E S found; f o u n d ; the t h e VERSION V E R S I O N of o f software s o f t w a r e tested; t e s t e d ; relevant r e l e v a n t hardware h a r d w a r e and a n d software s o f t w a r e test t e s t configurations; c o n f i g u r a t i o n s ; relevant r e l e v a n t test t e s t tools; t o o l s ; date d a t e tested; t e s t e d ; and a n d identification i d e n t i f i c a t i o n of o f the t h e tester. t e s t e r . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 37 3 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x A A (informative) ( i n f o r m a t i v e ) Rationale R a t i o n a l e for f o r the t h e requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d Rationale R a t i o n a l e for f o r the t h e clauses c l a u s e s of o f this t h i s standard s t a n d a r d is i s provided p r o v i d e d in i n this t h i s annex. a n n e x . A.1 A . 1 Rationale R a t i o n a l e The T h e primary p r i m a r y requirement r e q u i r e m e n t of o f this t h i s standard s t a n d a r d is i s that t h a t a a set s e t of o f PROCESSES P R O C E S S E S be b e followed f o l l o w e d in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , and a n d that t h a t the t h e choice c h o i c e of o f PROCESSES P R O C E S S E S be b e appropriate a p p r o p r i a t e to t o the t h e RISKS R I S K S to t o the t h e patient p a t i e n t and a n d other o t h e r people. p e o p l e . This T h i s follows f o l l o w s from f r o m the t h e belief b e l i e f that t h a t testing t e s t i n g of o f software s o f t w a r e is i s not n o t sufficient s u f f i c i e n t to t o determine d e t e r m i n e that t h a t it i t is i s safe s a f e in i n operation. o p e r a t i o n . The T h e PROCESSES P R O C E S S E S required r e q u i r e d by b y this t h i s standard s t a n d a r d fall f a l l into i n t o two t w o categories: c a t e g o r i e s : – – PROCESSES P R O C E S S E S which w h i c h are a r e required r e q u i r e d to t o determine d e t e r m i n e the t h e RISKS R I S K S arising a r i s i n g from f r o m the t h e operation o p e r a t i o n of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M in i n the t h e software; s o f t w a r e ; – – PROCESSES P R O C E S S E S which w h i c h are a r e required r e q u i r e d to t o achieve a c h i e v e an a n appropriately a p p r o p r i a t e l y low l o w probability p r o b a b i l i t y of o f software s o f t w a r e failure f a i l u r e for f o r each e a c h SOFTWARE S O F T W A R E ITEM, I T E M , chosen c h o s e n on o n the t h e basis b a s i s of o f these t h e s e determined d e t e r m i n e d RISKS. R I S K S . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e first f i r s t category c a t e g o r y to t o be b e performed p e r f o r m e d for f o r all a l l MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d the t h e second s e c o n d category c a t e g o r y to t o be b e performed p e r f o r m e d for f o r selected s e l e c t e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A claim c l a i m of o f compliance c o m p l i a n c e with w i t h this t h i s standard s t a n d a r d should s h o u l d therefore t h e r e f o r e include i n c l u d e a a documented d o c u m e n t e d RISK R I S K ANALYSIS A N A L Y S I S that t h a t identifies i d e n t i f i e s foreseeable f o r e s e e a b l e sequences s e q u e n c e s of o f events e v e n t s that t h a t include i n c l u d e software s o f t w a r e and a n d that t h a t can c a n result r e s u l t in i n a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N (see ( s e e ISO I S O 14971). 1 4 9 7 1 ) . HAZARDS H A Z A R D S HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t can c a n be b e indirectly i n d i r e c t l y caused c a u s e d by b y software s o f t w a r e (for ( f o r example, e x a m p l e , by b y providing p r o v i d i n g misleading m i s l e a d i n g information i n f o r m a t i o n that t h a t could c o u l d cause c a u s e inappropriate i n a p p r o p r i a t e treatment t r e a t m e n t to t o be b e administered) a d m i n i s t e r e d ) should s h o u l d be b e included i n c l u d e d in i n this t h i s RISK R I S K ANALYSIS. A N A L Y S I S . All A l l ACTIVITIES A C T I V I T I E S that t h a t are a r e required r e q u i r e d as a s part p a r t of o f the t h e first f i r s t category c a t e g o r y of o f PROCESSES P R O C E S S E S are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t as a s "[Class " [ C l a s s A, A , B, B , C]", C ] " , indicating i n d i c a t i n g that t h a t they t h e y are a r e required r e q u i r e d irrespective i r r e s p e c t i v e of o f the t h e classification c l a s s i f i c a t i o n of o f the t h e software s o f t w a r e to t o which w h i c h they t h e y apply. a p p l y . ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d for f o r all a l l classes c l a s s e s A, A , B, B , and a n d C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s a a plan p l a n relevant r e l e v a n t to t o RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s an a n output o u t p u t that t h a t is i s an a n input i n p u t to t o RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y is i s a a part p a r t of o f RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y establishes e s t a b l i s h e s an a n administration a d m i n i s t r a t i o n system, s y s t e m , documentation d o c u m e n t a t i o n or o r record-keeping r e c o r d - k e e p i n g system s y s t e m that t h a t supports s u p p o r t s RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y normally n o r m a l l y takes t a k e s place p l a c e when w h e n the t h e classification c l a s s i f i c a t i o n of o f the t h e related r e l a t e d software s o f t w a r e is i s unknown; u n k n o w n ; – – the t h e ACTIVITY A C T I V I T Y can c a n cause c a u s e a a change c h a n g e that t h a t could c o u l d invalidate i n v a l i d a t e the t h e current c u r r e n t software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e associated a s s o c i a t e d software. s o f t w a r e . This T h i s includes i n c l u d e s the t h e discovery d i s c o v e r y and a n d analysis a n a l y s i s of o f safety s a f e t y related r e l a t e d problems p r o b l e m s after a f t e r release. r e l e a s e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Other O t h e r PROCESSES P R O C E S S E S are a r e required r e q u i r e d only o n l y for f o r SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S or o r SOFTWARE S O F T W A R E ITEMS I T E M S classified c l a s s i f i e d in i n software s o f t w a r e safety s a f e t y classes c l a s s e s B B or o r C. C . ACTIVITIES A C T I V I T I E S required r e q u i r e d as a s parts p a r t s of o f these t h e s e PROCESSES P R O C E S S E S are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t as a s "[Class " [ C l a s s B, B , C]", C ] " , or o r "[Class " [ C l a s s C]" C ] " indicating i n d i c a t i n g that t h a t they t h e y are a r e required r e q u i r e d selectively s e l e c t i v e l y depending d e p e n d i n g on o n the t h e classification c l a s s i f i c a t i o n of o f the t h e software s o f t w a r e to t o which w h i c h they t h e y apply. a p p l y . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 38 3 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d selectively s e l e c t i v e l y for f o r software s o f t w a r e in i n classes c l a s s e s B B and a n d C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y enhances e n h a n c e s the t h e reliability r e l i a b i l i t y of o f the t h e software s o f t w a r e by b y requiring r e q u i r i n g more m o r e detail d e t a i l or o r more m o r e rigor r i g o r in i n the t h e design, d e s i g n , testing t e s t i n g or o r other o t h e r VERIFICATION; V E R I F I C A T I O N ; – – the t h e ACTIVITY A C T I V I T Y is i s an a n administrative a d m i n i s t r a t i v e ACTIVITY A C T I V I T Y that t h a t supports s u p p o r t s another a n o t h e r ACTIVITY A C T I V I T Y required r e q u i r e d for f o r classes c l a s s e s B B or o r C; C ; – – the t h e ACTIVITY A C T I V I T Y supports s u p p o r t s the t h e correction c o r r e c t i o n of o f safety-related s a f e t y - r e l a t e d problems; p r o b l e m s ; – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s records r e c o r d s of o f design, d e s i g n , implementation, i m p l e m e n t a t i o n , VERIFICATION V E R I F I C A T I O N and a n d release r e l e a s e of o f safety- s a f e t y - related r e l a t e d software. s o f t w a r e . ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d selectively s e l e c t i v e l y for f o r software s o f t w a r e in i n class c l a s s C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y further f u r t h e r enhances e n h a n c e s the t h e reliability r e l i a b i l i t y of o f the t h e software s o f t w a r e by b y requiring r e q u i r i n g more m o r e detail, d e t a i l , or o r more m o r e rigour, r i g o u r , or o r attention a t t e n t i o n to t o specific s p e c i f i c issues i s s u e s in i n the t h e design, d e s i g n , testing t e s t i n g or o r other o t h e r VERIFICATION V E R I F I C A T I O N Note N o t e that t h a t all a l l PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n this t h i s standard s t a n d a r d are a r e considered c o n s i d e r e d valuable v a l u a b l e in i n assuring a s s u r i n g the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f high h i g h quality q u a l i t y software. s o f t w a r e . The T h e omission o m i s s i o n of o f many m a n y of o f these t h e s e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S as a s requirements r e q u i r e m e n t s for f o r software s o f t w a r e in i n class c l a s s A A that t h a t cannot c a n n o t by b y definition d e f i n i t i o n cause c a u s e a a HAZARD H A Z A R D should s h o u l d not n o t imply i m p l y that t h a t these t h e s e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S would w o u l d not n o t be b e of o f value v a l u e or o r are a r e not n o t recommended. r e c o m m e n d e d . Their T h e i r omission o m i s s i o n is i s intended i n t e n d e d to t o recognize r e c o g n i z e that t h a t software s o f t w a r e that t h a t cannot c a n n o t cause c a u s e a a HAZARD H A Z A R D can c a n be b e easily e a s i l y assured a s s u r e d of o f SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s primarily p r i m a r i l y through t h r o u g h overall o v e r a l l validation v a l i d a t i o n ACTIVITY A C T I V I T Y during d u r i n g the t h e design d e s i g n of o f a a MEDICAL M E D I C A L DEVICE D E V I C E (which ( w h i c h is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard) s t a n d a r d ) and a n d through t h r o u g h some s o m e simple s i m p l e software s o f t w a r e life l i f e cycle c y c l e controls. c o n t r o l s . A.2 A . 2 Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y class c l a s s Table T a b l e A.1 A . 1 summarizes s u m m a r i z e s which w h i c h software s o f t w a r e safety s a f e t y classes c l a s s e s are a r e assigned a s s i g n e d to t o each e a c h requirement. r e q u i r e m e n t . This T h i s table t a b l e is i s informative i n f o r m a t i v e and a n d only o n l y provided p r o v i d e d for f o r convenience. c o n v e n i e n c e . The T h e normative n o r m a t i v e section s e c t i o n identifies i d e n t i f i e s the t h e software s o f t w a r e safety s a f e t y classes c l a s s e s for f o r each e a c h requirement. r e q u i r e m e n t . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 39 3 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e A.1 A . 1 – – Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y software s o f t w a r e safety s a f e t y class c l a s s Clauses C l a u s e s and a n d subclauses s u b c l a u s e s Class C l a s s A A Class C l a s s B B Class C l a s s C C Clause C l a u s e 4 4 All A l l requirements r e q u i r e m e n t s X X X X X X 5.1 5 . 1 5.1.1, 5 . 1 . 1 , 5.1.2, 5 . 1 . 2 , 5.1.3, 5 . 1 . 3 , 5.1.6, 5 . 1 . 6 , 5.1.7, 5 . 1 . 7 , 5.1.8, 5 . 1 . 8 , 5.1.9 5 . 1 . 9 X X X X X X 5.1.5, 5 . 1 . 5 , 5.1.10, 5 . 1 . 1 0 , 5.1.11, 5 . 1 . 1 1 , 5.1.12 5 . 1 . 1 2 X X X X 5.1.4 5 . 1 . 4 X X 5.2 5 . 2 5.2.1, 5 . 2 . 1 , 5.2.2, 5 . 2 . 2 , 5.2.4, 5 . 2 . 4 , 5.2.5, 5 . 2 . 5 , 5.2.6 5 . 2 . 6 X X X X X X 5.2.3 5 . 2 . 3 X X X X 5.3 5 . 3 5.3.1, 5 . 3 . 1 , 5.3.2, 5 . 3 . 2 , 5.3.3, 5 . 3 . 3 , 5.3.4, 5 . 3 . 4 , 5.3.6 5 . 3 . 6 X X X X 5.3.5 5 . 3 . 5 X X 5.4 5 . 4 5.4.1 5 . 4 . 1 X X X X 5.4.2, 5 . 4 . 2 , 5.4.3, 5 . 4 . 3 , 5.4.4 5 . 4 . 4 X X 5.5 5 . 5 5.5.1 5 . 5 . 1 X X X X X X 5.5.2, 5 . 5 . 2 , 5.5.3, 5 . 5 . 3 , 5.5.5 5 . 5 . 5 X X X X 5.5.4 5 . 5 . 4 X X 5.6 5 . 6 All A l l requirements r e q u i r e m e n t s X X X X 5.7 5 . 7 All A l l requirements r e q u i r e m e n t s X X X X X X 5.8 5 . 8 5.8.1, 5 . 8 . 1 , 5.8.2, 5 . 8 . 2 , 5.8.4, 5 . 8 . 4 , 5.8.7, 5 . 8 . 7 , 5.8.8 5 . 8 . 8 X X X X X X 5.8.1, 5 . 8 . 1 , 5.8.2, 5 . 8 . 2 , 5.8.3, 5 . 8 . 3 , 5.8.5, 5 . 8 . 5 , 5.8.6, 5 . 8 . 6 , 5.8.7, 5 . 8 . 7 , 5.8.8 5 . 8 . 8 X X X X 6.1 6 . 1 6.1 6 . 1 X X X X X X 6.2 6 . 2 6.2.1, 6 . 2 . 1 , 6.2.2, 6 . 2 . 2 , 6.2.4, 6 . 2 . 4 , 6.2.5 6 . 2 . 5 X X X X X X 6.2.3 6 . 2 . 3 X X X X 6.3 6 . 3 All A l l requirements r e q u i r e m e n t s X X X X X X Clause C l a u s e 6 6 All A l l requirements r e q u i r e m e n t s X X X X X X 7.1 7 . 1 All A l l requirements r e q u i r e m e n t s X X X X 7.2 7 . 2 All A l l requirements r e q u i r e m e n t s X X X X 7.3 7 . 3 All A l l requirements r e q u i r e m e n t s X X X X 7.4 7 . 4 7.4.1 7 . 4 . 1 X X X X X X 7.4.2, 7 . 4 . 2 , 7.4.3 7 . 4 . 3 X X X X Clause C l a u s e 8 8 All A l l requirements r e q u i r e m e n t s X X X X X X Clause C l a u s e 9 9 All A l l requirements r e q u i r e m e n t s X X X X X X Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 40 4 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x B B (informative) ( i n f o r m a t i v e ) Guidance G u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard s t a n d a r d B.1 B . 1 Scope S c o p e B.1.1 B . 1 . 1 Purpose P u r p o s e The T h e purpose p u r p o s e of o f this t h i s standard s t a n d a r d is i s to t o provide p r o v i d e a a development d e v e l o p m e n t PROCESS P R O C E S S that t h a t will w i l l consistently c o n s i s t e n t l y produce p r o d u c e high h i g h quality, q u a l i t y , safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . To T o accomplish a c c o m p l i s h this, t h i s , the t h e standard s t a n d a r d identifies i d e n t i f i e s the t h e minimum m i n i m u m ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S that t h a t need n e e d to t o be b e accomplished a c c o m p l i s h e d to t o provide p r o v i d e confidence c o n f i d e n c e that t h a t the t h e software s o f t w a r e has h a s been b e e n developed d e v e l o p e d in i n a a manner m a n n e r that t h a t is i s likely l i k e l y to t o produce p r o d u c e highly h i g h l y reliable r e l i a b l e and a n d safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S . . This T h i s annex a n n e x provides p r o v i d e s guidance g u i d a n c e for f o r the t h e application a p p l i c a t i o n of o f the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . It I t does d o e s not n o t add a d d to, t o , or o r otherwise o t h e r w i s e change, c h a n g e , the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . This T h i s annex a n n e x can c a n be b e used u s e d to t o better b e t t e r understand u n d e r s t a n d the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . Note N o t e that t h a t in i n this t h i s standard, s t a n d a r d , ACTIVITIES A C T I V I T I E S are a r e subclauses s u b c l a u s e s called c a l l e d out o u t within w i t h i n the t h e PROCESSES P R O C E S S E S and a n d TASKS T A S K S are a r e defined d e f i n e d within w i t h i n the t h e ACTIVITIES. A C T I V I T I E S . For F o r example, e x a m p l e , the t h e ACTIVITIES A C T I V I T I E S defined d e f i n e d for f o r the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S are a r e software s o f t w a r e development d e v e l o p m e n t planning, p l a n n i n g , software s o f t w a r e requirements r e q u i r e m e n t s analysis, a n a l y s i s , software s o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design, d e s i g n , software s o f t w a r e detailed d e t a i l e d design, d e s i g n , SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d VERIFICATION, V E R I F I C A T I O N , software s o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing, t e s t i n g , SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , and a n d software s o f t w a r e release. r e l e a s e . The T h e TASKS T A S K S within w i t h i n these t h e s e ACTIVITIES A C T I V I T I E S are a r e the t h e individual i n d i v i d u a l requirements. r e q u i r e m e n t s . This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e a a particular p a r t i c u l a r SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL. M O D E L . However, H o w e v e r , compliance c o m p l i a n c e with w i t h this t h i s standard s t a n d a r d does d o e s imply i m p l y dependencies d e p e n d e n c i e s between b e t w e e n PROCESSES, P R O C E S S E S , because b e c a u s e inputs i n p u t s of o f a a PROCESS P R O C E S S are a r e generated g e n e r a t e d by b y another a n o t h e r PROCESS. P R O C E S S . For F o r example, e x a m p l e , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M should s h o u l d be b e completed c o m p l e t e d after a f t e r the t h e RISK R I S K ANALYSIS A N A L Y S I S PROCESS P R O C E S S has h a s established e s t a b l i s h e d what w h a t HARM H A R M could c o u l d arise a r i s e from f r o m failure f a i l u r e of o f the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . Because B e c a u s e of o f such s u c h logical l o g i c a l dependencies d e p e n d e n c i e s between b e t w e e n processes, p r o c e s s e s , it i t is i s easiest e a s i e s t to t o describe d e s c r i b e the t h e processes p r o c e s s e s in i n this t h i s standard s t a n d a r d in i n a a sequence, s e q u e n c e , implying i m p l y i n g a a “waterfall” “ w a t e r f a l l ” or o r “once-through” “ o n c e - t h r o u g h ” life l i f e cycle c y c l e model. m o d e l . However, H o w e v e r , other o t h e r life l i f e cycles c y c l e s can c a n also a l s o be b e used. u s e d . Some S o m e development d e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d at a t ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] include i n c l u d e (see ( s e e also a l s o Table T a b l e B.1): B . 1 ) : – – Waterfall. W a t e r f a l l . The T h e “once-through" “ o n c e - t h r o u g h " strategy, s t r a t e g y , also a l s o called c a l l e d “waterfall”, “ w a t e r f a l l ” , consists c o n s i s t s of o f performing p e r f o r m i n g the t h e development d e v e l o p m e n t PROCESS P R O C E S S a a single s i n g l e time. t i m e . Simplistically: S i m p l i s t i c a l l y : determine d e t e r m i n e customer c u s t o m e r needs, n e e d s , define d e f i n e requirements, r e q u i r e m e n t s , design d e s i g n the t h e SYSTEM, S Y S T E M , implement i m p l e m e n t the t h e system, s y s t e m , test, t e s t , fix f i x and a n d deliver. d e l i v e r . – – Incremental: I n c r e m e n t a l : The T h e “incremental” “ i n c r e m e n t a l ” strategy s t r a t e g y determines d e t e r m i n e s customer c u s t o m e r needs n e e d s and a n d defines d e f i n e s the t h e SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , then t h e n performs p e r f o r m s the t h e rest r e s t of o f the t h e development d e v e l o p m e n t in i n a a sequence s e q u e n c e of o f builds. b u i l d s . The T h e first f i r s t build b u i l d incorporates i n c o r p o r a t e s part p a r t of o f the t h e planned p l a n n e d capabilities, c a p a b i l i t i e s , the t h e next n e x t build b u i l d adds a d d s more m o r e capabilities, c a p a b i l i t i e s , and a n d so s o on, o n , until u n t i l the t h e SYSTEM S Y S T E M is i s complete. c o m p l e t e . – – Evolutionary: E v o l u t i o n a r y : The T h e “evolutionary” “ e v o l u t i o n a r y ” strategy s t r a t e g y also a l s o develops d e v e l o p s a a SYSTEM S Y S T E M in i n builds b u i l d s but b u t differs d i f f e r s from f r o m the t h e incremental i n c r e m e n t a l strategy s t r a t e g y in i n acknowledging a c k n o w l e d g i n g that t h a t the t h e user u s e r need n e e d is i s not n o t fully f u l l y understood u n d e r s t o o d and a n d all a l l requirements r e q u i r e m e n t s cannot c a n n o t be b e defined d e f i n e d up u p front. f r o n t . In I n this t h i s strategy, s t r a t e g y , customer c u s t o m e r needs n e e d s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s are a r e partially p a r t i a l l y defined d e f i n e d up u p front, f r o n t , then t h e n are a r e refined r e f i n e d in i n each e a c h succeeding s u c c e e d i n g build. b u i l d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 41 4 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e B.1 B . 1 – – Development D e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 Development D e v e l o p m e n t Strategy S t r a t e g y Define D e f i n e all a l l requirements r e q u i r e m e n t s first? f i r s t ? Waterfall W a t e r f a l l (Once-through) ( O n c e - t h r o u g h ) Incremental I n c r e m e n t a l (Preplanned ( P r e p l a n n e d product p r o d u c t improvement) i m p r o v e m e n t ) Multiple M u l t i p l e development d e v e l o p m e n t cycles? c y c l e s ? Distribute D i s t r i b u t e interim i n t e r i m software? s o f t w a r e ? yes y e s no n o no n o yes y e s yes y e s maybe m a y b e Evolutionary E v o l u t i o n a r y no n o yes y e s yes y e s Whichever W h i c h e v e r life l i f e cycle c y c l e is i s chosen c h o s e n it i t is i s necessary n e c e s s a r y to t o maintain m a i n t a i n the t h e logical l o g i c a l dependencies d e p e n d e n c i e s between b e t w e e n PROCESS P R O C E S S outputs o u t p u t s such s u c h as a s specifications, s p e c i f i c a t i o n s , design d e s i g n documents d o c u m e n t s and a n d software. s o f t w a r e . The T h e waterfall w a t e r f a l l life l i f e cycle c y c l e model m o d e l achieves a c h i e v e s this t h i s by b y delaying d e l a y i n g the t h e start s t a r t of o f a a PROCESS P R O C E S S until u n t i l the t h e inputs i n p u t s for f o r that t h a t PROCESS P R O C E S S are a r e complete c o m p l e t e and a n d approved. a p p r o v e d . Other O t h e r life l i f e cycles, c y c l e s , particularly p a r t i c u l a r l y evolutionary e v o l u t i o n a r y life l i f e cycles, c y c l e s , permit p e r m i t PROCESS P R O C E S S outputs o u t p u t s to t o be b e produced p r o d u c e d before b e f o r e all a l l the t h e inputs i n p u t s for f o r that t h a t PROCESS P R O C E S S are a r e available. a v a i l a b l e . For F o r example, e x a m p l e , a a new n e w SOFTWARE S O F T W A R E ITEM I T E M can c a n be b e specified, s p e c i f i e d , classified, c l a s s i f i e d , implemented i m p l e m e n t e d and a n d VERIFIED V E R I F I E D before b e f o r e the t h e whole w h o l e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E has h a s been b e e n finalised. f i n a l i s e d . Such S u c h life l i f e cycles c y c l e s carry c a r r y the t h e RISK R I S K that t h a t a a change c h a n g e or o r development d e v e l o p m e n t in i n one o n e PROCESS P R O C E S S output o u t p u t will w i l l invalidate i n v a l i d a t e another a n o t h e r PROCESS P R O C E S S output. o u t p u t . All A l l life l i f e cycles c y c l e s therefore t h e r e f o r e use u s e a a comprehensive c o m p r e h e n s i v e configuration c o n f i g u r a t i o n management m a n a g e m e n t system s y s t e m to t o ensure e n s u r e that t h a t all a l l PROCESS P R O C E S S outputs o u t p u t s are a r e brought b r o u g h t to t o a a consistent c o n s i s t e n t state s t a t e and a n d the t h e dependencies d e p e n d e n c i e s maintained. m a i n t a i n e d . The T h e following f o l l o w i n g principles p r i n c i p l e s are a r e important i m p o r t a n t regardless r e g a r d l e s s of o f the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle c y c l e used: u s e d : – – All A l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e maintained m a i n t a i n e d in i n a a consistent c o n s i s t e n t state; s t a t e ; whenever w h e n e v e r any a n y PROCESS P R O C E S S output o u t p u t is i s created c r e a t e d or o r changed, c h a n g e d , all a l l related r e l a t e d PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e updated u p d a t e d promptly p r o m p t l y to t o maintain m a i n t a i n their t h e i r consistency c o n s i s t e n c y with w i t h each e a c h other o t h e r and a n d to t o maintain m a i n t a i n all a l l dependencies d e p e n d e n c i e s explicitly e x p l i c i t l y or o r implicitly i m p l i c i t l y required r e q u i r e d by b y this t h i s standard; s t a n d a r d ; – – all a l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e available a v a i l a b l e when w h e n needed n e e d e d as a s input i n p u t to t o further f u r t h e r work w o r k on o n the t h e software. s o f t w a r e . – – before b e f o r e any a n y MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s released, r e l e a s e d , all a l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e consistent c o n s i s t e n t with w i t h each e a c h other o t h e r and a n d all a l l dependencies d e p e n d e n c i e s between b e t w e e n PROCESS P R O C E S S outputs o u t p u t s explicitly e x p l i c i t l y or o r implicitly i m p l i c i t l y required r e q u i r e d by b y this t h i s standard s t a n d a r d should s h o u l d be b e observed. o b s e r v e d . B.1.2 B . 1 . 2 Field F i e l d of o f application a p p l i c a t i o n This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E as a s well w e l l as a s the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f a a MEDICAL M E D I C A L DEVICE D E V I C E that t h a t includes i n c l u d e s SOUP. S O U P . The T h e use u s e of o f this t h i s standard s t a n d a r d requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o perform p e r f o r m MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971. 1 4 9 7 1 . Therefore, T h e r e f o r e , when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E includes i n c l u d e s an a n acquired a c q u i r e d component c o m p o n e n t (this ( t h i s could c o u l d be b e a a purchased p u r c h a s e d component c o m p o n e n t or o r a a component c o m p o n e n t of o f unknown u n k n o w n provenance), p r o v e n a n c e ) , such s u c h as a s a a printer/plotter p r i n t e r / p l o t t e r that t h a t includes i n c l u d e s SOUP, S O U P , the t h e acquired a c q u i r e d component c o m p o n e n t becomes b e c o m e s the t h e responsibility r e s p o n s i b i l i t y of o f the t h e MANUFACTURER M A N U F A C T U R E R and a n d must m u s t be b e included i n c l u d e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T of o f the t h e MEDICAL M E D I C A L DEVICE. D E V I C E . It I t is i s assumed a s s u m e d that t h a t through t h r o u g h proper p r o p e r performance p e r f o r m a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT, M A N A G E M E N T , the t h e MANUFACTURER M A N U F A C T U R E R would w o u l d understand u n d e r s t a n d the t h e component c o m p o n e n t and a n d recognize r e c o g n i z e that t h a t it i t includes i n c l u d e s SOUP. S O U P . The T h e MANUFACTURER M A N U F A C T U R E R using u s i n g this t h i s standard s t a n d a r d would w o u l d invoke i n v o k e the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S as a s part p a r t of o f the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e maintenance m a i n t e n a n c e of o f released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E applies a p p l i e s to t o the t h e post-production p o s t - p r o d u c t i o n experience e x p e r i e n c e with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Software S o f t w a r e maintenance m a i n t e n a n c e includes i n c l u d e s the t h e combination c o m b i n a t i o n of o f all a l l technical t e c h n i c a l and a n d administrative a d m i n i s t r a t i v e means, m e a n s , including i n c l u d i n g supervision s u p e r v i s i o n actions, a c t i o n s , to t o act a c t on o n problem p r o b l e m reports r e p o r t s to t o retain r e t a i n an a n item i t e m in, i n , or o r restore r e s t o r e it i t to, t o , a a state s t a t e in i n which w h i c h it i t can c a n perform p e r f o r m a a required r e q u i r e d function f u n c t i o n as a s well w e l l as a s modification m o d i f i c a t i o n requests r e q u e s t s related r e l a t e d to t o released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 42 4 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 SOFTWARE S O F T W A R E PRODUCT(S). P R O D U C T ( S ) . For F o r example, e x a m p l e , this t h i s includes i n c l u d e s problem p r o b l e m rectification, r e c t i f i c a t i o n , regulatory r e g u l a t o r y reporting, r e p o r t i n g , re- r e - validation v a l i d a t i o n and a n d preventive p r e v e n t i v e action. a c t i o n . See S e e ISO/IEC I S O / I E C 14764 1 4 7 6 4 [10]. [ 1 0 ] . B.2 B . 2 Normative N o r m a t i v e references r e f e r e n c e s ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15] [ 1 5 ] provides p r o v i d e s guidance g u i d a n c e for f o r applying a p p l y i n g a a quality q u a l i t y management m a n a g e m e n t system s y s t e m to t o software s o f t w a r e development. d e v e l o p m e n t . This T h i s guidance g u i d a n c e is i s not n o t required r e q u i r e d by b y this t h i s standard s t a n d a r d but b u t is i s highly h i g h l y recommended. r e c o m m e n d e d . B.3 B . 3 Terms T e r m s and a n d definitions d e f i n i t i o n s Where W h e r e possible, p o s s i b l e , terms t e r m s have h a v e been b e e n defined d e f i n e d using u s i n g definitions d e f i n i t i o n s from f r o m international i n t e r n a t i o n a l standards. s t a n d a r d s . This T h i s standard s t a n d a r d chose c h o s e to t o use u s e three t h r e e terms t e r m s to t o describe d e s c r i b e the t h e decomposition d e c o m p o s i t i o n of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (top ( t o p level). l e v e l ) . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n be b e a a subsystem s u b s y s t e m of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E (see ( s e e IEC I E C 60601- 6 0 6 0 1 - 1- 1 - 4 4 [2]) [ 2 ] ) or o r a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right, r i g h t , which w h i c h then t h e n becomes b e c o m e s a a software s o f t w a r e MEDICAL M E D I C A L DEVICE. D E V I C E . The T h e lowest l o w e s t level l e v e l that t h a t is i s not n o t further f u r t h e r decomposed d e c o m p o s e d for f o r the t h e purposes p u r p o s e s of o f testing t e s t i n g or o r software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t is i s the t h e SOFTWARE S O F T W A R E UNIT. U N I T . All A l l levels l e v e l s of o f composition, c o m p o s i t i o n , including i n c l u d i n g the t h e top t o p and a n d bottom b o t t o m levels, l e v e l s , can c a n be b e called c a l l e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , then, t h e n , is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d each e a c h SOFTWARE S O F T W A R E ITEM I T E M is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E UNITS U N I T S or o r decomposable d e c o m p o s a b l e SOFTWARE S O F T W A R E ITEMS. I T E M S . The T h e responsibility r e s p o n s i b i l i t y is i s left l e f t to t o the t h e MANUFACTURER M A N U F A C T U R E R to t o provide p r o v i d e the t h e definition d e f i n i t i o n and a n d granularity g r a n u l a r i t y of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SOFTWARE S O F T W A R E UNITS. U N I T S . Leaving L e a v i n g these t h e s e terms t e r m s vague v a g u e allows a l l o w s one o n e to t o apply a p p l y them t h e m to t o the t h e many m a n y different d i f f e r e n t development d e v e l o p m e n t methods m e t h o d s and a n d types t y p e s of o f software s o f t w a r e used u s e d in i n MEDICAL M E D I C A L DEVICES. D E V I C E S . B.4 B . 4 General G e n e r a l requirements r e q u i r e m e n t s There T h e r e is i s no n o known k n o w n method m e t h o d to t o guarantee g u a r a n t e e 100 1 0 0 % % SAFETY S A F E T Y for f o r any a n y kind k i n d of o f software. s o f t w a r e . There T h e r e are a r e three t h r e e major m a j o r principles p r i n c i p l e s which w h i c h promote p r o m o t e SAFETY S A F E T Y for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE: S O F T W A R E : – – RISK R I S K MANAGEMENT; M A N A G E M E N T ; – – quality q u a l i t y management; m a n a g e m e n t ; – – software s o f t w a r e engineering. e n g i n e e r i n g . For F o r the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E it i t is i s necessary n e c e s s a r y to t o establish e s t a b l i s h RISK R I S K MANAGEMENT M A N A G E M E N T as a s an a n integral i n t e g r a l part p a r t of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m as a s an a n overall o v e r a l l framework f r a m e w o r k for f o r the t h e application a p p l i c a t i o n of o f appropriate a p p r o p r i a t e software s o f t w a r e engineering e n g i n e e r i n g methods m e t h o d s and a n d techniques. t e c h n i q u e s . The T h e combination c o m b i n a t i o n of o f these t h e s e three t h r e e concepts c o n c e p t s allows a l l o w s a a MEDICAL M E D I C A L DEVICE D E V I C E MANUFACTURER M A N U F A C T U R E R to t o follow f o l l o w a a clearly c l e a r l y structured s t r u c t u r e d and a n d consistently c o n s i s t e n t l y repeatable r e p e a t a b l e decision-making d e c i s i o n - m a k i n g PROCESS P R O C E S S to t o promote p r o m o t e SAFETY S A F E T Y for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . B.4.1 B . 4 . 1 Quality Q u a l i t y management m a n a g e m e n t system s y s t e m Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . A A disciplined d i s c i p l i n e d and a n d effective e f f e c t i v e set s e t of o f software s o f t w a r e PROCESSES P R O C E S S E S includes i n c l u d e s organizational o r g a n i z a t i o n a l PROCESSES P R O C E S S E S such s u c h as a s management, m a n a g e m e n t , infrastructure, i n f r a s t r u c t u r e , improvement, i m p r o v e m e n t , and a n d training. t r a i n i n g . To T o avoid a v o i d duplication d u p l i c a t i o n and a n d to t o focus f o c u s this t h i s standard s t a n d a r d on o n software s o f t w a r e engineering, e n g i n e e r i n g , these t h e s e PROCESSES P R O C E S S E S have h a v e been b e e n omitted o m i t t e d from f r o m this t h i s standard. s t a n d a r d . These T h e s e PROCESSES P R O C E S S E S are a r e covered c o v e r e d by b y a a quality q u a l i t y management m a n a g e m e n t system. s y s t e m . ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] is i s an a n International I n t e r n a t i o n a l Standard S t a n d a r d that t h a t is i s specifically s p e c i f i c a l l y intended i n t e n d e d for f o r applying a p p l y i n g the t h e concepts c o n c e p t s of o f quality q u a l i t y management m a n a g e m e n t to t o MEDICAL M E D I C A L DEVICES. D E V I C E S . Conformance C o n f o r m a n c e to t o ISO I S O 13485 1 3 4 8 5 quality q u a l i t y management m a n a g e m e n t system s y s t e m requirements r e q u i r e m e n t s does d o e s not n o t automatically a u t o m a t i c a l l y constitute c o n s t i t u t e conformity c o n f o r m i t y with w i t h national n a t i o n a l or o r regional r e g i o n a l regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . It I t is i s the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S responsibility r e s p o n s i b i l i t y to t o identify i d e n t i f y and a n d establish e s t a b l i s h compliance c o m p l i a n c e with w i t h relevant r e l e v a n t regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 43 4 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 B.4.2 B . 4 . 2 RISK R I S K MANAGEMENT M A N A G E M E N T Software S o f t w a r e development d e v e l o p m e n t participates p a r t i c i p a t e s in i n RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S sufficiently s u f f i c i e n t l y to t o ensure e n s u r e that t h a t all a l l reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E are a r e considered. c o n s i d e r e d . Rather R a t h e r than t h a n trying t r y i n g to t o define d e f i n e an a n appropriate a p p r o p r i a t e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s software s o f t w a r e engineering e n g i n e e r i n g standard, s t a n d a r d , it i t is i s required r e q u i r e d that t h a t the t h e MANUFACTURER M A N U F A C T U R E R apply a p p l y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971, 1 4 9 7 1 , which w h i c h deals d e a l s explicitly e x p l i c i t l y with w i t h RISK R I S K MANAGEMENT M A N A G E M E N T for f o r MEDICAL M E D I C A L DEVICES. D E V I C E S . Specific S p e c i f i c software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S resulting r e s u l t i n g from f r o m HAZARDS H A Z A R D S HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t have h a v e software s o f t w a r e as a s a a contributing c o n t r i b u t i n g cause c a u s e are a r e identified i d e n t i f i e d in i n a a supporting s u p p o r t i n g PROCESS P R O C E S S described d e s c r i b e d in i n Clause C l a u s e 7. 7 . B.4.3 B . 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e RISK R I S K associated a s s o c i a t e d with w i t h software s o f t w a r e as a s a a part p a r t of o f a a MEDICAL M E D I C A L DEVICE, D E V I C E , as a s an a n accessory a c c e s s o r y to t o a a MEDICAL M E D I C A L DEVICE, D E V I C E , or o r as a s a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right, r i g h t , is i s used u s e d as a s the t h e input i n p u t to t o a a software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme, s c h e m e , which w h i c h then t h e n determines d e t e r m i n e s the t h e PROCESSES P R O C E S S E S to t o be b e used u s e d during d u r i n g the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f software. s o f t w a r e . RISK R I S K is i s considered c o n s i d e r e d to t o be b e a a combination c o m b i n a t i o n of o f the t h e severity s e v e r i t y of o f injury i n j u r y HARM H A R M and a n d the t h e probability p r o b a b i l i t y of o f its i t s occurrence. o c c u r r e n c e . However, H o w e v e r , there t h e r e is i s no n o consensus c o n s e n s u s on o n how h o w to t o determine d e t e r m i n e the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f software s o f t w a r e failures f a i l u r e s using u s i n g traditional t r a d i t i o n a l statistical s t a t i s t i c a l methods. m e t h o d s . In I n this t h i s standard, s t a n d a r d , therefore, t h e r e f o r e , SOFTWARE S O F T W A R E SYSTEM S Y S T E M classification c l a s s i f i c a t i o n is i s based b a s e d on o n the t h e severity s e v e r i t y of o f the t h e HAZARD H A Z A R D resulting r e s u l t i n g from f r o m failure f a i l u r e of o f the t h e software, s o f t w a r e , assuming a s s u m i n g that t h a t the t h e failure f a i l u r e will w i l l occur. o c c u r . S S OFTWARE O F T W A R E SYSTEMS S Y S T E M S that t h a t contribute c o n t r i b u t e to t o the t h e implementation i m p l e m e n t a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s are a r e classified c l a s s i f i e d based b a s e d on o n the t h e severity s e v e r i t y of o f the t h e HAZARD H A Z A R D they t h e y are a r e controlling. c o n t r o l l i n g . However, H o w e v e r , no n o consensus c o n s e n s u s exists e x i s t s for f o r a a method m e t h o d of o f quantitatively q u a n t i t a t i v e l y estimating e s t i m a t i n g the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f a a software s o f t w a r e failure. f a i l u r e . When W h e n software s o f t w a r e is i s present p r e s e n t in i n a a sequence s e q u e n c e or o r combination c o m b i n a t i o n of o f events e v e n t s leading l e a d i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , the t h e probability p r o b a b i l i t y of o f the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g cannot c a n n o t be b e considered c o n s i d e r e d in i n estimating e s t i m a t i n g the t h e RISK R I S K for f o r the t h e HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . In I n such s u c h cases, c a s e s , considering c o n s i d e r i n g a a worst w o r s t case c a s e probability p r o b a b i l i t y is i s appropriate, a p p r o p r i a t e , and a n d the t h e probability p r o b a b i l i t y for f o r the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g should s h o u l d be b e set s e t to t o 1. 1 . When W h e n it i t is i s possible p o s s i b l e to t o estimate e s t i m a t e the t h e probability p r o b a b i l i t y for f o r the t h e remaining r e m a i n i n g events e v e n t s in i n the t h e sequence s e q u e n c e (as ( a s it i t may m a y be b e if i f they t h e y are a r e not n o t software) s o f t w a r e ) that t h a t probability p r o b a b i l i t y can c a n be b e used u s e d for f o r the t h e probability p r o b a b i l i t y of o f the t h e HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N occurring o c c u r r i n g (P ( P 1 1 in i n Figure F i g u r e B.2). B . 2 ) . In I n many m a n y cases c a s e s however, h o w e v e r , it i t might m i g h t not n o t be b e possible p o s s i b l e to t o estimate e s t i m a t e the t h e probability p r o b a b i l i t y for f o r the t h e remaining r e m a i n i n g events e v e n t s in i n the t h e sequence, s e q u e n c e , and a n d the t h e RISK R I S K should s h o u l d be b e EVALUATED E V A L U A T E D on o n the t h e basis b a s i s of o f the t h e nature n a t u r e of o f the t h e HARM H A R M alone a l o n e (the ( t h e probability p r o b a b i l i t y of o f the t h e HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N occurring o c c u r r i n g should s h o u l d be b e set s e t to t o 1). 1 ) . RISK R I S K ESTIMATION E S T I M A T I O N in i n these t h e s e cases c a s e s should s h o u l d be b e focused f o c u s e d on o n the t h e SEVERITY S E V E R I T Y of o f the t h e HARM H A R M resulting r e s u l t i n g from f r o m the t h e HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . Subjective S u b j e c t i v e rankings r a n k i n g s of o f probability p r o b a b i l i t y can c a n also a l s o be b e assigned a s s i g n e d based b a s e d on o n clinical c l i n i c a l knowledge k n o w l e d g e to t o distinguish d i s t i n g u i s h failures f a i l u r e s that t h a t a a clinician c l i n i c i a n would w o u l d be b e likely l i k e l y to t o detect d e t e c t from f r o m those t h o s e that t h a t would w o u l d not n o t be b e detected d e t e c t e d and a n d would w o u l d be b e more m o r e likely l i k e l y to t o cause c a u s e HARM. H A R M . Estimates E s t i m a t e s of o f probability p r o b a b i l i t y of o f a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N leading l e a d i n g to t o HARM H A R M (P ( P 2 2 in i n Figure F i g u r e B.2) B . 2 ) generally g e n e r a l l y require r e q u i r e clinical c l i n i c a l knowledge k n o w l e d g e to t o distinguish d i s t i n g u i s h between b e t w e e n HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S where w h e r e clinical c l i n i c a l practice p r a c t i c e would w o u l d be b e likely l i k e l y to t o prevent p r e v e n t HARM, H A R M , and a n d HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t would w o u l d be b e more m o r e likely l i k e l y to t o cause c a u s e HARM. H A R M . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 44 4 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Sequence S e q u e n c e of o f events e v e n t s Hazard H a z a r d Hazardous H a z a r d o u s situation s i t u a t i o n Exposure E x p o s u r e (P1) ( P 1 ) P2 P 2 Harm H a r m Severity S e v e r i t y of o f the t h e harm h a r m Probability P r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f harm h a r m Risk R i s k P1 P 1 × × P2 P 2 NOTE N O T E P P 1 1 is i s the t h e probability p r o b a b i l i t y of o f a a hazardous h a z a r d o u s situation s i t u a t i o n occurring o c c u r r i n g IEC I E C P P 2 2 is i s the t h e probability p r o b a b i l i t y of o f a a hazardous h a z a r d o u s situation s i t u a t i o n leading l e a d i n g to t o harm h a r m Figure F i g u r e B.2 B . 2 – – Pictorial P i c t o r i a l representation r e p r e s e n t a t i o n of o f the t h e relationship r e l a t i o n s h i p of o f HAZARD, H A Z A R D , sequence s e q u e n c e of o f events, e v e n t s , HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , and a n d HARM H A R M – – from f r o m ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 Annex A n n e x E E If I f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s decomposed d e c o m p o s e d into i n t o SOFTWARE S O F T W A R E ITEMS, I T E M S , then t h e n each e a c h SOFTWARE S O F T W A R E ITEM I T E M can c a n have h a v e its i t s own o w n software s o f t w a r e safety s a f e t y classification. c l a s s i f i c a t i o n . It I t is i s only o n l y possible p o s s i b l e to t o determine d e t e r m i n e the t h e RISK R I S K associated a s s o c i a t e d with w i t h failure f a i l u r e of o f a a SOFTWARE S O F T W A R E ITEM: I T E M : – – if i f a a SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d a a software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E define d e f i n e the t h e role r o l e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M in i n terms t e r m s of o f its i t s purpose p u r p o s e and a n d its i t s interfaces i n t e r f a c e s with w i t h other o t h e r software s o f t w a r e and a n d hardware h a r d w a r e items; i t e m s ; – – if i f changes c h a n g e s to t o the t h e SYSTEM S Y S T E M are a r e controlled; c o n t r o l l e d ; – – after a f t e r RISK R I S K ANALYSIS A N A L Y S I S has h a s been b e e n done d o n e on o n the t h e ARCHITECTURE A R C H I T E C T U R E and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s specified. s p e c i f i e d . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e minimum m i n i m u m number n u m b e r of o f ACTIVITIES A C T I V I T I E S that t h a t will w i l l achieve a c h i e v e the t h e above a b o v e conditions c o n d i t i o n s for f o r all a l l classes c l a s s e s of o f software. s o f t w a r e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e end e n d of o f the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E ACTIVITY A C T I V I T Y is i s the t h e earliest e a r l i e s t point p o i n t in i n the t h e development d e v e l o p m e n t when w h e n the t h e full f u l l set s e t of o f SOFTWARE S O F T W A R E ITEMS I T E M S is i s defined d e f i n e d and a n d the t h e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITY A C T I V I T Y has h a s identified i d e n t i f i e d how h o w the t h e SOFTWARE S O F T W A R E ITEMS I T E M S relate r e l a t e to t o SAFETY. S A F E T Y . This T h i s is i s therefore t h e r e f o r e the t h e earliest e a r l i e s t point p o i n t at a t which w h i c h SOFTWARE S O F T W A R E ITEMS I T E M S can c a n be b e classified c l a s s i f i e d definitively d e f i n i t i v e l y according a c c o r d i n g to t o their t h e i r SAFETY S A F E T Y role. r o l e . This T h i s point p o i n t corresponds c o r r e s p o n d s to t o the t h e point p o i n t where w h e r e RISK R I S K CONTROL C O N T R O L is i s begun b e g u n in i n ISO I S O 14971. 1 4 9 7 1 . Before B e f o r e this t h i s point, p o i n t , the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S identifies i d e n t i f i e s ARCHITECTURAL A R C H I T E C T U R A L RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , for f o r example e x a m p l e adding a d d i n g protective p r o t e c t i v e subsystems, s u b s y s t e m s , or o r reducing r e d u c i n g the t h e opportunities o p p o r t u n i t i e s for f o r software s o f t w a r e failures f a i l u r e s to t o cause c a u s e HARM. H A R M . After A f t e r this t h i s point, p o i n t , the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S uses u s e s PROCESSES P R O C E S S E S aimed a i m e d at a t reducing r e d u c i n g the t h e probability p r o b a b i l i t y of o f failure f a i l u r e of o f SOFTWARE S O F T W A R E ITEMS. I T E M S . In I n other o t h e r words, w o r d s , the t h e classification c l a s s i f i c a t i o n of o f a a SOFTWARE S O F T W A R E ITEM I T E M specifies s p e c i f i e s PROCESS-based P R O C E S S - b a s e d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o be b e applied a p p l i e d to t o that t h a t item. i t e m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 45 4 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 It I t is i s expected e x p e c t e d that t h a t MANUFACTURERS M A N U F A C T U R E R S will w i l l find f i n d it i t useful u s e f u l to t o classify c l a s s i f y software s o f t w a r e before b e f o r e this t h i s point, p o i n t , for f o r example e x a m p l e to t o focus f o c u s attention a t t e n t i o n on o n areas a r e a s to t o be b e investigated, i n v e s t i g a t e d , but b u t such s u c h classification c l a s s i f i c a t i o n should s h o u l d be b e regarded r e g a r d e d as a s preliminary p r e l i m i n a r y and a n d should s h o u l d not n o t be b e used u s e d to t o justify j u s t i f y the t h e omission o m i s s i o n of o f PROCESSES. P R O C E S S E S . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme s c h e m e is i s not n o t intended i n t e n d e d to t o align a l i g n with w i t h the t h e RISK R I S K classifications c l a s s i f i c a t i o n s of o f ISO I S O 14971. 1 4 9 7 1 . Whereas W h e r e a s the t h e ISO I S O 14971 1 4 9 7 1 scheme s c h e m e classifies c l a s s i f i e s RISK R I S K according a c c o r d i n g to t o their t h e i r severity s e v e r i t y and a n d likelihood, l i k e l i h o o d , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme s c h e m e classifies c l a s s i f i e s SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S and a n d SOFTWARE S O F T W A R E ITEMS I T E M S according a c c o r d i n g to t o the t h e PROCESSES P R O C E S S E S to t o be b e applied a p p l i e d in i n their t h e i r development d e v e l o p m e n t and a n d maintenance. m a i n t e n a n c e . As A s the t h e design d e s i g n evolves, e v o l v e s , new n e w RISKS R I S K S might m i g h t become b e c o m e evident. e v i d e n t . Therefore, T h e r e f o r e , RISK R I S K MANAGEMENT M A N A G E M E N T should s h o u l d be b e applied a p p l i e d as a s an a n integral i n t e g r a l part p a r t of o f the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . This T h i s permits p e r m i t s the t h e development d e v e l o p m e n t of o f an a n ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n that t h a t identifies i d e n t i f i e s a a complete c o m p l e t e set s e t of o f SOFTWARE S O F T W A R E ITEMS, I T E M S , including i n c l u d i n g those t h o s e that t h a t are a r e required r e q u i r e d to t o function f u n c t i o n correctly c o r r e c t l y to t o assure a s s u r e safe s a f e operation o p e r a t i o n and a n d those t h o s e that t h a t prevent p r e v e n t faults f a u l t s from f r o m causing c a u s i n g HARM. H A R M . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E should s h o u l d promote p r o m o t e segregation s e g r e g a t i o n of o f software s o f t w a r e items i t e m s that t h a t are a r e required r e q u i r e d for f o r safe s a f e operation o p e r a t i o n and a n d should s h o u l d describe d e s c r i b e the t h e methods m e t h o d s used u s e d to t o ensure e n s u r e effective e f f e c t i v e segregation s e g r e g a t i o n of o f those t h o s e SOFTWARE S O F T W A R E ITEMS. I T E M S . Segregation S e g r e g a t i o n is i s not n o t restricted r e s t r i c t e d to t o physical p h y s i c a l (processor ( p r o c e s s o r or o r memory m e m o r y partition) p a r t i t i o n ) separation s e p a r a t i o n but b u t includes i n c l u d e s any a n y mechanism m e c h a n i s m that t h a t prevents p r e v e n t s one o n e SOFTWARE S O F T W A R E ITEM I T E M from f r o m negatively n e g a t i v e l y affecting a f f e c t i n g another. a n o t h e r . The T h e adequacy a d e q u a c y of o f a a segregation s e g r e g a t i o n is i s determined d e t e r m i n e d based b a s e d on o n the t h e RISKS R I S K S involved i n v o l v e d and a n d the t h e rationale r a t i o n a l e which w h i c h is i s required r e q u i r e d to t o be b e documented. d o c u m e n t e d . As A s stated s t a t e d in i n B.3, B . 3 , this t h i s standard s t a n d a r d chooses c h o o s e s to t o use u s e three t h r e e terms t e r m s to t o describe d e s c r i b e the t h e decomposition d e c o m p o s i t i o n of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (top ( t o p level). l e v e l ) . Figure F i g u r e B.1 B . 1 illustrates i l l u s t r a t e s the t h e possible p o s s i b l e partitioning p a r t i t i o n i n g for f o r SOFTWARE S O F T W A R E ITEMS I T E M S within w i t h i n a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d how h o w the t h e software s o f t w a r e safety s a f e t y classes c l a s s e s would w o u l d be b e applied a p p l i e d to t o the t h e group g r o u p of o f SOFTWARE S O F T W A R E ITEMS I T E M S in i n the t h e decomposition. d e c o m p o s i t i o n . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 46 4 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M / / SOFTWARE S O F T W A R E ITEM I T E M (CLASS ( C L A S S C) C ) SOFTWARE S O F T W A R E ITEM I T E M X X (Class ( C l a s s A) A ) SOFTWARE S O F T W A R E ITEM I T E M Y Y (Class ( C l a s s C) C ) SOFTWARE S O F T W A R E ITEM I T E M W W (Class ( C l a s s B) B ) SOFTWARE S O F T W A R E ITEM I T E M Z Z (Class ( C l a s s C) C ) IEC I E C 724/06 7 2 4 / 0 6 Figure F i g u r e B.1 B . 1 – – Example E x a m p l e of o f partitioning p a r t i t i o n i n g of o f SOFTWARE S O F T W A R E ITEMS I T E M S For F o r this t h i s example, e x a m p l e , the t h e MANUFACTURER M A N U F A C T U R E R knows, k n o w s , due d u e to t o the t h e type t y p e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E being b e i n g developed, d e v e l o p e d , that t h a t the t h e preliminary p r e l i m i n a r y software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n for f o r the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s C. C . During D u r i n g software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E design d e s i g n the t h e MANUFACTURER M A N U F A C T U R E R has h a s decided d e c i d e d to t o partition p a r t i t i o n the t h e SYSTEM, S Y S T E M , as a s shown, s h o w n , with w i t h 3 3 SOFTWARE S O F T W A R E ITEMS I T E M S – – X, X , W W and a n d Z. Z . The T h e MANUFACTURER M A N U F A C T U R E R is i s able a b l e to t o segregate s e g r e g a t e all a l l SOFTWARE S O F T W A R E SYSTEM S Y S T E M contributions c o n t r i b u t i o n s to t o HAZARDS H A Z A R D S HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h could c o u l d result r e s u l t in i n death d e a t h or o r SERIOUS S E R I O U S INJURY I N J U R Y to t o SOFTWARE S O F T W A R E ITEM I T E M Z Z and a n d all a l l remaining r e m a i n i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M contributions c o n t r i b u t i o n s to t o HAZARDS H A Z A R D S HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h could c o u l d result r e s u l t in i n a a non-SERIOUS n o n - S E R I O U S INJURY I N J U R Y to t o SOFTWARE S O F T W A R E ITEM I T E M W. W . SOFTWARE S O F T W A R E ITEm I T E m W W is i s classified c l a s s i f i e d as a s software s o f t w a r e safety s a f e t y class c l a s s B B and a n d SOFTWARE S O F T W A R E ITEM I T E M Z Z is i s at a t software s o f t w a r e safety s a f e t y class c l a s s C. C . SOFTWARE S O F T W A R E ITEM I T E M Y Y therefore t h e r e f o r e must m u s t be b e classified c l a s s i f i e d as a s Class C l a s s C, C , per p e r 4.3 4 . 3 d). d ) . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s also a l s o at a t a a software s o f t w a r e safety s a f e t y class c l a s s C C per p e r this t h i s requirement. r e q u i r e m e n t . SOFTWARE S O F T W A R E ITEM I T E M X X has h a s been b e e n classified c l a s s i f i e d at a t a a software s o f t w a r e safety s a f e t y class c l a s s of o f A. A . The T h e MANUFACTURER M A N U F A C T U R E R is i s able a b l e to t o document d o c u m e n t a a rationale r a t i o n a l e for f o r the t h e segregation s e g r e g a t i o n between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S X X and a n d Y, Y , as a s well w e l l as a s SOFTWARE S O F T W A R E ITEMS I T E M S W W and a n d Z, Z , to t o assure a s s u r e the t h e integrity i n t e g r i t y of o f the t h e segregation. s e g r e g a t i o n . If I f partitioning p a r t i t i o n i n g segregation s e g r e g a t i o n is i s not n o t possible p o s s i b l e between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S X X and a n d Y, Y , then t h e n SOFTWARE S O F T W A R E ITEM I T E M X X must m u s t be b e classified c l a s s i f i e d in i n software s o f t w a r e safety s a f e t y class c l a s s C. C . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.4.4 B . 4 . 4 LEGACY L E G A C Y SOFTWARE S O F T W A R E Subclause S u b c l a u s e 4.4 4 . 4 establishes e s t a b l i s h e s a a process p r o c e s s for f o r application a p p l i c a t i o n of o f this t h i s standard s t a n d a r d to t o LEGACY L E G A C Y SOFTWARE. S O F T W A R E . Some S o m e geographies g e o g r a p h i e s may m a y require r e q u i r e the t h e MANUFACTURER M A N U F A C T U R E R to t o show s h o w conformity c o n f o r m i t y to t o the t h e standard s t a n d a r d to t o obtain o b t a i n regulatory r e g u l a t o r y approval a p p r o v a l of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , even e v e n if i f that t h a t software s o f t w a r e was w a s designed d e s i g n e d prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version v e r s i o n of o f the t h e standard s t a n d a r d (LEGACY ( L E G A C Y SOFTWARE). S O F T W A R E ) . In I n this t h i s case, c a s e , the t h e requirements r e q u i r e m e n t s in i n 4.4 4 . 4 provide p r o v i d e a a method m e t h o d for f o r the t h e the t h e MANUFACTURER M A N U F A C T U R E R to t o demonstrate d e m o n s t r a t e compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E to t o the t h e standard. s t a n d a r d . A A MANUFACTURER M A N U F A C T U R E R may m a y determine d e t e r m i n e that t h a t retrospective r e t r o s p e c t i v e documentation d o c u m e n t a t i o n of o f an a n already a l r e a d y finished f i n i s h e d development-lifecycle d e v e l o p m e n t - l i f e c y c l e performed p e r f o r m e d as a s an a n isolated i s o l a t e d activity a c t i v i t y does d o e s not n o t result r e s u l t in i n the t h e reduction r e d u c t i o n of o f RISK R I S K associated a s s o c i a t e d with w i t h the t h e use u s e of o f the t h e product. p r o d u c t . The T h e process p r o c e s s results r e s u l t s in i n the t h e identification i d e n t i f i c a t i o n of o f a a subset s u b s e t of o f granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 47 4 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n this t h i s standard s t a n d a r d which w h i c h does d o e s result r e s u l t in i n reduction r e d u c t i o n of o f RISK. R I S K . Some S o m e additional a d d i t i o n a l goals g o a l s implicit i m p l i c i t in i n the t h e process p r o c e s s are: a r e : – – required r e q u i r e d ACTIVITIES A C T I V I T I E S and a n d resulting r e s u l t i n g documentation d o c u m e n t a t i o n should s h o u l d rely r e l y on o n and a n d make m a k e use u s e of, o f , wherever w h e r e v e r possible, p o s s i b l e , existing e x i s t i n g documentation, d o c u m e n t a t i o n , and a n d – – a a MANUFACTURER M A N U F A C T U R E R should s h o u l d utilize u t i l i z e resources r e s o u r c e s as a s effectively e f f e c t i v e l y as a s possible p o s s i b l e to t o effect e f f e c t a a reduction r e d u c t i o n of o f RISK. R I S K . In I n addition a d d i t i o n to t o a a plan p l a n identifying i d e n t i f y i n g the t h e subset s u b s e t of o f ACTIVITIES A C T I V I T I E S to t o execute, e x e c u t e , the t h e process p r o c e s s also a l s o results r e s u l t s in i n objective o b j e c t i v e evidence e v i d e n c e supporting s u p p o r t i n g safe s a f e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d a a summary s u m m a r y rationale r a t i o n a l e for f o r this t h i s conclusion. c o n c l u s i o n . The T h e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e planned p l a n n e d continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E depend d e p e n d on o n the t h e context c o n t e x t in i n which w h i c h the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e used u s e d to t o create c r e a t e a a SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e MANUFACTURER M A N U F A C T U R E R will w i l l document d o c u m e n t all a l l identified i d e n t i f i e d MEDICAL M E D I C A L DEVICE D E V I C E HAZARDS H A Z A R D S associated a s s o c i a t e d with w i t h the t h e LEGACY L E G A C Y SOFTWARE. S O F T W A R E . Subclause S u b c l a u s e 4.4 4 . 4 requires r e q u i r e s a a comprehensive c o m p r e h e n s i v e assessment a s s e s s m e n t of o f available a v a i l a b l e post-production p o s t - p r o d u c t i o n field f i e l d data d a t a obtained o b t a i n e d for f o r the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E during d u r i n g the t h e time t i m e it i t has h a s been b e e n in i n production p r o d u c t i o n and a n d use. u s e . Typical T y p i c a l sources s o u r c e s of o f post- p o s t - production p r o d u c t i o n data d a t a include: i n c l u d e : – – adverse a d v e r s e events e v e n t s attributable a t t r i b u t a b l e to t o the t h e device, d e v i c e , – – feedback f e e d b a c k received r e c e i v e d from f r o m users u s e r s of o f the t h e device, d e v i c e , and a n d – – ANOMALIES A N O M A L I E S discovered d i s c o v e r e d by b y the t h e MANUFACTURER. M A N U F A C T U R E R . Though T h o u g h no n o consensus c o n s e n s u s exists e x i s t s for f o r a a method m e t h o d of o f prospectively p r o s p e c t i v e l y estimating e s t i m a t i n g quantitatively q u a n t i t a t i v e l y the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f a a software s o f t w a r e failure, f a i l u r e , such s u c h information i n f o r m a t i o n may m a y be b e available a v a i l a b l e for f o r LEGACY L E G A C Y SOFTWARE, S O F T W A R E , based b a s e d on o n the t h e usage u s a g e of o f such s u c h software s o f t w a r e and a n d EVALUATION E V A L U A T I O N of o f post-production p o s t - p r o d u c t i o n data. d a t a . If I f it i t is i s possible p o s s i b l e in i n such s u c h cases c a s e s to t o quantitatively q u a n t i t a t i v e l y estimate e s t i m a t e the t h e probability p r o b a b i l i t y of o f events e v e n t s in i n the t h e sequence, s e q u e n c e , a a quantitative q u a n t i t a t i v e value v a l u e may m a y be b e used u s e d for f o r expressing e x p r e s s i n g the t h e probability p r o b a b i l i t y of o f the t h e entire e n t i r e sequence s e q u e n c e of o f events e v e n t s occurring. o c c u r r i n g . If I f such s u c h quantitative q u a n t i t a t i v e estimation e s t i m a t i o n is i s not n o t possible, p o s s i b l e , considering c o n s i d e r i n g a a worst w o r s t case c a s e probability p r o b a b i l i t y is i s appropriate, a p p r o p r i a t e , and a n d the t h e probability p r o b a b i l i t y for f o r the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g should s h o u l d be b e assumed a s s u m e d to t o be b e 1. 1 . The T h e MANUFACTURER M A N U F A C T U R E R determination d e t e r m i n a t i o n of o f how h o w the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e used u s e d in i n the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E is i s input i n p u t to t o the t h e assessment a s s e s s m e n t of o f RISK. R I S K . The T h e RISKS R I S K S to t o be b e considered c o n s i d e r e d vary v a r y accordingly. a c c o r d i n g l y . – – When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E has h a s been b e e n safely s a f e l y and a n d reliably r e l i a b l y used u s e d and a n d the t h e MANUFACTURER M A N U F A C T U R E R wishes w i s h e s to t o continue c o n t i n u e use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e rationale r a t i o n a l e for f o r continued c o n t i n u e d use u s e rests r e s t s primarily p r i m a r i l y on o n the t h e assessment a s s e s s m e n t of o f RISK R I S K based b a s e d on o n post-production p o s t - p r o d u c t i o n records. r e c o r d s . – – When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E is i s reused r e u s e d to t o create c r e a t e a a new n e w SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , the t h e intended i n t e n d e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E might m i g h t be b e different d i f f e r e n t from f r o m its i t s original o r i g i n a l intended i n t e n d e d use. u s e . In I n this t h i s case c a s e the t h e RISK R I S K assessment a s s e s s m e n t must m u s t take t a k e into i n t o account a c c o u n t the t h e modified m o d i f i e d set s e t of o f HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h can c a n arise a r i s e due d u e to t o failures f a i l u r e s of o f the t h e LEGACY L E G A C Y SOFTWARE. S O F T W A R E . – – A A reused r e u s e d LEGACY L E G A C Y SOFTWARE S O F T W A R E may m a y be b e used u s e d for f o r similar s i m i l a r intended i n t e n d e d use u s e but b u t integrated i n t e g r a t e d into i n t o a a new n e w SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . In I n this t h i s case c a s e the t h e RISK R I S K assessment a s s e s s m e n t should s h o u l d take t a k e into i n t o account a c c o u n t modification m o d i f i c a t i o n of o f architectural a r c h i t e c t u r a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s according a c c o r d i n g to t o 5.3. 5 . 3 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e changed c h a n g e d and a n d used u s e d within w i t h i n a a new n e w SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d consider c o n s i d e r how h o w the t h e existing e x i s t i n g records r e c o r d s of o f safe s a f e and a n d reliable r e l i a b l e operation o p e r a t i o n may m a y be b e invalidated i n v a l i d a t e d by b y the t h e changes. c h a n g e s . Changes C h a n g e s to t o the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E should s h o u l d be b e performed p e r f o r m e d according a c c o r d i n g to t o Clauses C l a u s e s 4 4 to t o 9 9 of o f this t h i s standard, s t a n d a r d , including i n c l u d i n g assessment a s s e s s m e n t of o f impact i m p a c t to t o RISK R I S K CONTROL C O N T R O L measures m e a s u r e s according a c c o r d i n g to t o 7.4. 7 . 4 . In I n the t h e case c a s e of o f LEGACY L E G A C Y SOFTWARE, S O F T W A R E , existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s may m a y not n o t be b e fully f u l l y documented d o c u m e n t e d and a n d special s p e c i a l care c a r e should s h o u l d be b e taken t a k e n to t o EVALUATE E V A L U A T E the t h e potential p o t e n t i a l impact i m p a c t of o f changes, c h a n g e s , utilizing u t i l i z i n g available a v a i l a b l e documented d o c u m e n t e d design d e s i g n records r e c o r d s as a s well w e l l as a s expertise e x p e r t i s e of o f individuals i n d i v i d u a l s having h a v i n g knowledge k n o w l e d g e of o f the t h e system. s y s t e m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 48 4 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 According A c c o r d i n g to t o 4.4, 4 . 4 , the t h e MANUFACTURER M A N U F A C T U R E R performs p e r f o r m s a a gap g a p analysis a n a l y s i s in i n order o r d e r to t o determine d e t e r m i n e the t h e available a v a i l a b l e documentation d o c u m e n t a t i o n including i n c l u d i n g objective o b j e c t i v e evidence e v i d e n c e of o f performed p e r f o r m e d TASKS T A S K S done d o n e during d u r i n g development d e v e l o p m e n t of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d compared c o m p a r e d to t o 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7. 7 . Typical T y p i c a l steps s t e p s to t o accomplish a c c o m p l i s h this t h i s gap g a p analysis a n a l y s i s include i n c l u d e identification i d e n t i f i c a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , including i n c l u d i n g VERSION, V E R S I O N , revision r e v i s i o n and a n d any a n y other o t h e r means, m e a n s , required r e q u i r e d for f o r clear c l e a r identification; i d e n t i f i c a t i o n ; EVALUATION E V A L U A T I O N of o f existing e x i s t i n g DELIVERABLES D E L I V E R A B L E S corresponding c o r r e s p o n d i n g to t o the t h e deliverables d e l i v e r a b l e s required r e q u i r e d by b y 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7; 7 ; EVALUATION E V A L U A T I O N of o f available a v a i l a b l e objective o b j e c t i v e evidence, e v i d e n c e , documenting d o c u m e n t i n g the t h e previously p r e v i o u s l y applied a p p l i e d software s o f t w a r e development d e v e l o p m e n t lifecycle l i f e c y c l e model m o d e l (as ( a s appropriate); a p p r o p r i a t e ) ; EVALUATION E V A L U A T I O N of o f the t h e adequacy a d e q u a c y of o f existing e x i s t i n g RISK R I S K MANAGEMENT M A N A G E M E N T documentation, d o c u m e n t a t i o n , taking t a k i n g ISO I S O 14971 1 4 9 7 1 into i n t o account. a c c o u n t . Taking T a k i n g the t h e performed p e r f o r m e d gap g a p analysis a n a l y s i s into i n t o account, a c c o u n t , the t h e MANUFACTURER M A N U F A C T U R E R will w i l l EVALUATE E V A L U A T E the t h e potential p o t e n t i a l reduction r e d u c t i o n in i n RISK R I S K resulting r e s u l t i n g from f r o m the t h e generation g e n e r a t i o n of o f the t h e missing m i s s i n g DELIVERABLES D E L I V E R A B L E S and a n d associated a s s o c i a t e d ACTIVITIES, A C T I V I T I E S , and a n d create c r e a t e a a plan p l a n to t o perform p e r f o r m ACTIVITIES A C T I V I T I E S and a n d generate g e n e r a t e DELIVERABLES D E L I V E R A B L E S to t o close c l o s e these t h e s e gaps. g a p s . Reduction R e d u c t i o n of o f RISK R I S K should s h o u l d balance b a l a n c e the t h e benefit b e n e f i t of o f applying a p p l y i n g the t h e software s o f t w a r e development d e v e l o p m e n t process p r o c e s s according a c c o r d i n g to t o Clause C l a u s e 5 5 against a g a i n s t the t h e possibility p o s s i b i l i t y that t h a t modification m o d i f i c a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E without w i t h o u t full f u l l knowledge k n o w l e d g e of o f its i t s development d e v e l o p m e n t history h i s t o r y could c o u l d introduce i n t r o d u c e new n e w defects d e f e c t s that t h a t increase i n c r e a s e the t h e risk. r i s k . Some S o m e of o f the t h e elements e l e m e n t s of o f Clause C l a u s e 5 5 may m a y be b e assessed a s s e s s e d to t o have h a v e little l i t t l e to t o no n o reduction r e d u c t i o n of o f RISK R I S K when w h e n done d o n e after a f t e r the t h e fact. f a c t . For F o r example, e x a m p l e , detailed d e t a i l e d design d e s i g n and a n d unit u n i t verification v e r i f i c a t i o n reduce r e d u c e RISK R I S K primarily p r i m a r i l y during d u r i n g the t h e process p r o c e s s of o f developing d e v e l o p i n g new n e w software s o f t w a r e or o r refactoring r e f a c t o r i n g existing e x i s t i n g software. s o f t w a r e . If I f these t h e s e objectives o b j e c t i v e s are a r e not n o t planned, p l a n n e d , performing p e r f o r m i n g the t h e ACTIVITIES A C T I V I T I E S in i n isolation i s o l a t i o n may m a y create c r e a t e documentation d o c u m e n t a t i o n but b u t lead l e a d to t o no n o reduction r e d u c t i o n in i n RISK. R I S K . At A t a a minimum, m i n i m u m , the t h e gap g a p closure c l o s u r e plan p l a n addresses a d d r e s s e s missing m i s s i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t records. r e c o r d s . If I f these t h e s e do d o not n o t exist e x i s t or o r are a r e not n o t suitable s u i t a b l e to t o support s u p p o r t a a rationale r a t i o n a l e to t o continue c o n t i n u e use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e gap g a p closure c l o s u r e plan p l a n should s h o u l d include i n c l u d e creation c r e a t i o n of o f SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s at a t a a functional f u n c t i o n a l level l e v e l according a c c o r d i n g to t o 5.2 5 . 2 and a n d tests t e s t s according a c c o r d i n g to t o 5.7. 5 . 7 . The T h e documented d o c u m e n t e d rationale r a t i o n a l e for f o r continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E builds b u i l d s on o n the t h e available a v a i l a b l e objective o b j e c t i v e evidence e v i d e n c e and a n d analysis a n a l y s i s obtained o b t a i n e d in i n the t h e course c o u r s e of o f assessing a s s e s s i n g the t h e RISK R I S K and a n d creating c r e a t i n g a a gap g a p closure c l o s u r e plan p l a n appropriate a p p r o p r i a t e for f o r the t h e context c o n t e x t of o f LEGACY L E G A C Y SOFTARE S O F T A R E reuse. r e u s e . The T h e rationale r a t i o n a l e makes m a k e s a a positive p o s i t i v e case c a s e for f o r the t h e safe s a f e and a n d reliable r e l i a b l e performace p e r f o r m a c e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n the t h e planned p l a n n e d reuse r e u s e context, c o n t e x t , taking t a k i n g into i n t o account a c c o u n t both b o t h the t h e post-production p o s t - p r o d u c t i o n records r e c o r d s available a v a i l a b l e for f o r the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d the t h e RISK R I S K CONTROL C O N T R O L MEASURES M E A S U R E S affected a f f e c t e d by b y filling f i l l i n g process p r o c e s s gaps. g a p s . After A f t e r LEGACY L E G A C Y SOFTWARE S O F T W A R E has h a s been b e e n re-used r e - u s e d according a c c o r d i n g to t o 4.4, 4 . 4 , those t h o s e parts p a r t s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E for f o r which w h i c h gaps g a p s in i n DELIVERABLES D E L I V E R A B L E S remain, r e m a i n , continue c o n t i n u e to t o be b e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d may m a y be b e considered c o n s i d e r e d for f o r further f u r t h e r re-use r e - u s e again a g a i n according a c c o r d i n g to t o 4.4. 4 . 4 . When W h e n gaps g a p s in i n deliverables d e l i v e r a b l e s are a r e closed c l o s e d by b y changing c h a n g i n g the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e changes c h a n g e s should s h o u l d be b e performed p e r f o r m e d according a c c o r d i n g to t o Clauses C l a u s e s 4 4 to t o 9 9 of o f this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5 B . 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S B.5.1 B . 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g The T h e objective o b j e c t i v e of o f this t h i s ACTIVITY A C T I V I T Y is i s to t o plan p l a n the t h e software s o f t w a r e development d e v e l o p m e n t TASKS T A S K S to t o reduce r e d u c e RISKS R I S K S caused c a u s e d by b y software, s o f t w a r e , communicate c o m m u n i c a t e procedures p r o c e d u r e s and a n d goals g o a l s to t o members m e m b e r s of o f the t h e development d e v e l o p m e n t team, t e a m , and a n d ensure e n s u r e that t h a t SYSTEM S Y S T E M quality q u a l i t y requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E are a r e met. m e t . The T h e software s o f t w a r e development d e v e l o p m e n t planning p l a n n i n g ACTIVITY A C T I V I T Y can c a n document d o c u m e n t TASKS T A S K S in i n a a single s i n g l e plan p l a n or o r in i n multiple m u l t i p l e plans. p l a n s . Some S o m e MANUFACTURERS M A N U F A C T U R E R S might m i g h t have h a v e established e s t a b l i s h e d policies p o l i c i e s and a n d procedures p r o c e d u r e s that t h a t apply a p p l y to t o the t h e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 49 4 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 development d e v e l o p m e n t of o f all a l l their t h e i r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . In I n this t h i s case c a s e the t h e plan p l a n can c a n simply s i m p l y reference r e f e r e n c e the t h e existing e x i s t i n g policies p o l i c i e s and a n d procedures. p r o c e d u r e s . Some S o m e MANUFACTURERS M A N U F A C T U R E R S might m i g h t prepare p r e p a r e a a plan p l a n or o r set s e t of o f plans p l a n s specific s p e c i f i c to t o the t h e development d e v e l o p m e n t of o f each e a c h MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T that t h a t spell s p e l l out o u t in i n detail d e t a i l specific s p e c i f i c ACTIVITIES A C T I V I T I E S and a n d reference r e f e r e n c e general g e n e r a l procedures. p r o c e d u r e s . Another A n o t h e r possibility p o s s i b i l i t y is i s that t h a t a a plan p l a n or o r set s e t of o f plans p l a n s is i s tailored t a i l o r e d for f o r the t h e development d e v e l o p m e n t of o f each e a c h MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T . . The T h e planning p l a n n i n g should s h o u l d be b e specified s p e c i f i e d at a t the t h e level l e v e l of o f detail d e t a i l necessary n e c e s s a r y to t o carry c a r r y out o u t the t h e development d e v e l o p m e n t PROCESS P R O C E S S and a n d should s h o u l d be b e proportional p r o p o r t i o n a l to t o the t h e RISK. R I S K . For F o r example, e x a m p l e , SYSTEMS S Y S T E M S or o r items i t e m s with w i t h higher h i g h e r RISK R I S K would w o u l d be b e subject s u b j e c t to t o a a development d e v e l o p m e n t PROCESS P R O C E S S with w i t h more m o r e rigor r i g o r and a n d TASKS T A S K S should s h o u l d be b e spelled s p e l l e d out o u t in i n greater g r e a t e r detail. d e t a i l . Planning P l a n n i n g is i s an a n iterative i t e r a t i v e ACTIVITY A C T I V I T Y that t h a t should s h o u l d be b e re-examined r e - e x a m i n e d and a n d updated u p d a t e d as a s development d e v e l o p m e n t progresses. p r o g r e s s e s . The T h e plan p l a n can c a n evolve e v o l v e to t o incorporate i n c o r p o r a t e more m o r e and a n d better b e t t e r information i n f o r m a t i o n as a s more m o r e is i s understood u n d e r s t o o d about a b o u t the t h e SYSTEM S Y S T E M and a n d the t h e level l e v e l of o f effort e f f o r t needed n e e d e d to t o develop d e v e l o p the t h e SYSTEM. S Y S T E M . For F o r example, e x a m p l e , a a SYSTEM’s S Y S T E M ’ s initial i n i t i a l software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n can c a n change c h a n g e as a s a a result r e s u l t of o f exercising e x e r c i s i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S and a n d development d e v e l o p m e n t of o f the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . Or O r it i t might m i g h t be b e decided d e c i d e d that t h a t a a SOUP S O U P be b e incorporated i n c o r p o r a t e d into i n t o the t h e SYSTEM. S Y S T E M . It I t is i s important i m p o r t a n t that t h a t the t h e plan(s) p l a n ( s ) be b e updated u p d a t e d to t o reflect r e f l e c t current c u r r e n t knowledge k n o w l e d g e of o f the t h e SYSTEM S Y S T E M and a n d the t h e level l e v e l of o f rigor r i g o r needed n e e d e d for f o r the t h e SYSTEM S Y S T E M or o r items i t e m s in i n the t h e SYSTEM S Y S T E M to t o enable e n a b l e proper p r o p e r control c o n t r o l over o v e r the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . B.5.2 B . 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o establish e s t a b l i s h and a n d verify v e r i f y the t h e software s o f t w a r e requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Establishing E s t a b l i s h i n g verifiable v e r i f i a b l e requirements r e q u i r e m e n t s is i s essential e s s e n t i a l for f o r determining d e t e r m i n i n g what w h a t is i s to t o be b e built, b u i l t , for f o r determining d e t e r m i n i n g that t h a t the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E exhibits e x h i b i t s acceptable a c c e p t a b l e behaviour, b e h a v i o u r , and a n d for f o r demonstrating d e m o n s t r a t i n g that t h a t the t h e completed c o m p l e t e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s ready r e a d y for f o r use. u s e . To T o demonstrate d e m o n s t r a t e that t h a t the t h e requirements r e q u i r e m e n t s have h a v e been b e e n implemented i m p l e m e n t e d as a s desired, d e s i r e d , each e a c h requirement r e q u i r e m e n t should s h o u l d be b e stated s t a t e d in i n such s u c h a a way w a y that t h a t objective o b j e c t i v e criteria c r i t e r i a can c a n be b e established e s t a b l i s h e d to t o determine d e t e r m i n e whether w h e t h e r it i t has h a s been b e e n implemented i m p l e m e n t e d correctly. c o r r e c t l y . If I f the t h e device d e v i c e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S imposes i m p o s e s requirements r e q u i r e m e n t s on o n the t h e software s o f t w a r e to t o control c o n t r o l identified i d e n t i f i e d RISKS, R I S K S , these t h e s e requirements r e q u i r e m e n t s are a r e to t o be b e identified i d e n t i f i e d in i n the t h e software s o f t w a r e requirements r e q u i r e m e n t s in i n such s u c h a a way w a y as a s to t o make m a k e it i t possible p o s s i b l e to t o trace t r a c e the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . All A l l software s o f t w a r e requirements r e q u i r e m e n t s should s h o u l d be b e identified i d e n t i f i e d in i n such s u c h a a way w a y as a s to t o make m a k e it i t possible p o s s i b l e to t o demonstrate d e m o n s t r a t e TRACEABILITY T R A C E A B I L I T Y between b e t w e e n the t h e requirement r e q u i r e m e n t and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing. t e s t i n g . If I f regulatory r e g u l a t o r y approval a p p r o v a l in i n some s o m e countries c o u n t r i e s requires r e q u i r e s conformance c o n f o r m a n c e to t o specific s p e c i f i c regulations r e g u l a t i o n s or o r international i n t e r n a t i o n a l standards, s t a n d a r d s , this t h i s conformance c o n f o r m a n c e requirement r e q u i r e m e n t should s h o u l d be b e documented d o c u m e n t e d in i n the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . Because B e c a u s e the t h e software s o f t w a r e requirements r e q u i r e m e n t s establish e s t a b l i s h what w h a t is i s to t o be b e implemented i m p l e m e n t e d in i n the t h e software, s o f t w a r e , an a n evaluation e v a l u a t i o n of o f the t h e requirements r e q u i r e m e n t s is i s required r e q u i r e d before b e f o r e the t h e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY A C T I V I T Y is i s complete. c o m p l e t e . An A n area a r e a of o f frequent f r e q u e n t confusion c o n f u s i o n is i s the t h e distinction d i s t i n c t i o n between b e t w e e n customer c u s t o m e r needs, n e e d s , design d e s i g n inputs, i n p u t s , software s o f t w a r e requirements, r e q u i r e m e n t s , software s o f t w a r e functional f u n c t i o n a l specifications, s p e c i f i c a t i o n s , and a n d software s o f t w a r e design d e s i g n specifications. s p e c i f i c a t i o n s . Design D e s i g n inputs i n p u t s are a r e the t h e interpretation i n t e r p r e t a t i o n of o f customer c u s t o m e r needs n e e d s into i n t o formally f o r m a l l y documented d o c u m e n t e d MEDICAL M E D I C A L DEVICE D E V I C E requirements. r e q u i r e m e n t s . Software S o f t w a r e requirements r e q u i r e m e n t s are a r e the t h e formally f o r m a l l y documented d o c u m e n t e d specifications s p e c i f i c a t i o n s of o f what w h a t the t h e software s o f t w a r e does d o e s to t o meet m e e t the t h e customer c u s t o m e r needs n e e d s and a n d the t h e design d e s i g n inputs. i n p u t s . Software S o f t w a r e functional f u n c t i o n a l specifications s p e c i f i c a t i o n s are a r e often o f t e n included i n c l u d e d with w i t h the t h e software s o f t w a r e requirements r e q u i r e m e n t s and a n d define d e f i n e in i n detail d e t a i l what w h a t the t h e software s o f t w a r e does d o e s to t o meet m e e t its i t s requirements r e q u i r e m e n t s even e v e n though t h o u g h many m a n y different d i f f e r e n t alternatives a l t e r n a t i v e s might m i g h t also a l s o meet m e e t the t h e requirements. r e q u i r e m e n t s . Software S o f t w a r e design d e s i g n specifications s p e c i f i c a t i o n s define d e f i n e how h o w the t h e software s o f t w a r e will w i l l be b e designed d e s i g n e d and a n d decomposed d e c o m p o s e d to t o implement i m p l e m e n t its i t s requirements r e q u i r e m e n t s and a n d functional f u n c t i o n a l specifications. s p e c i f i c a t i o n s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Traditionally, T r a d i t i o n a l l y , software s o f t w a r e requirements, r e q u i r e m e n t s , functional f u n c t i o n a l specifications, s p e c i f i c a t i o n s , and a n d design d e s i g n specifications s p e c i f i c a t i o n s have h a v e been b e e n written w r i t t e n as a s a a set s e t of o f one o n e or o r more m o r e documents. d o c u m e n t s . It I t is i s now n o w feasible f e a s i b l e to t o consider c o n s i d e r this t h i s information i n f o r m a t i o n as a s data d a t a items i t e m s within w i t h i n a a common c o m m o n database. d a t a b a s e . Each E a c h item i t e m would w o u l d have h a v e one o n e or o r more m o r e attributes a t t r i b u t e s that t h a t would w o u l d define d e f i n e its i t s purpose p u r p o s e and a n d linkage l i n k a g e to t o other o t h e r items i t e m s in i n the t h e database. d a t a b a s e . This T h i s approach a p p r o a c h allows a l l o w s presentation p r e s e n t a t i o n and a n d printing p r i n t i n g of o f different d i f f e r e n t views v i e w s of o f the t h e information i n f o r m a t i o n best b e s t suited s u i t e d for f o r each e a c h set s e t of o f intended i n t e n d e d users u s e r s (e.g., ( e . g . , marketing, m a r k e t i n g , MANUFACTURERS, M A N U F A C T U R E R S , testers, t e s t e r s , auditors) a u d i t o r s ) and a n d supports s u p p o r t s TRACEABILITY T R A C E A B I L I T Y to t o demonstrate d e m o n s t r a t e adequate a d e q u a t e implementation i m p l e m e n t a t i o n and a n d the t h e extent e x t e n t to t o which w h i c h test t e s t cases c a s e s test t e s t the t h e requirements. r e q u i r e m e n t s . Tools T o o l s to t o support s u p p o r t this t h i s approach a p p r o a c h can c a n be b e as a s simple s i m p l e as a s a a hypertext h y p e r t e x t document d o c u m e n t using u s i n g HTML H T M L hyperlinks h y p e r l i n k s or o r as a s complex c o m p l e x and a n d capable c a p a b l e as a s computer c o m p u t e r aided a i d e d software s o f t w a r e engineering e n g i n e e r i n g (CASE) ( C A S E ) tools t o o l s and a n d requirements r e q u i r e m e n t s analysis a n a l y s i s tools. t o o l s . The T h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s PROCESS P R O C E S S is i s out o u t of o f scope s c o p e of o f this t h i s standard. s t a n d a r d . However, H o w e v e r , the t h e decision d e c i s i o n to t o implement i m p l e m e n t MEDICAL M E D I C A L DEVICE D E V I C E functionality f u n c t i o n a l i t y with w i t h software s o f t w a r e is i s normally n o r m a l l y made m a d e during d u r i n g SYSTEM S Y S T E M design. d e s i g n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 50 5 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Some S o m e or o r all a l l of o f the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s are a r e allocated a l l o c a t e d to t o be b e implemented i m p l e m e n t e d in i n software. s o f t w a r e . The T h e software s o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY A C T I V I T Y consists c o n s i s t s of o f analyzing a n a l y z i n g the t h e requirements r e q u i r e m e n t s allocated a l l o c a t e d to t o software s o f t w a r e by b y the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s PROCESS P R O C E S S and a n d deriving d e r i v i n g a a comprehensive c o m p r e h e n s i v e set s e t of o f software s o f t w a r e requirements r e q u i r e m e n t s that t h a t reflect r e f l e c t the t h e allocated a l l o c a t e d requirements. r e q u i r e m e n t s . To T o ensure e n s u r e the t h e integrity i n t e g r i t y of o f the t h e SYSTEM, S Y S T E M , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d provide p r o v i d e a a mechanism m e c h a n i s m for f o r negotiating n e g o t i a t i n g changes c h a n g e s and a n d clarifications c l a r i f i c a t i o n s to t o the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s to t o correct c o r r e c t impracticalities, i m p r a c t i c a l i t i e s , inconsistencies i n c o n s i s t e n c i e s or o r ambiguities a m b i g u i t i e s in i n either e i t h e r the t h e parent p a r e n t SYSTEM S Y S T E M requirements r e q u i r e m e n t s or o r the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . The T h e PROCESS P R O C E S S of o f capture c a p t u r e and a n d analysis a n a l y s i s of o f SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e iterative. i t e r a t i v e . This T h i s standard s t a n d a r d does d o e s not n o t intend i n t e n d to t o require r e q u i r e the t h e PROCESSES P R O C E S S E S to t o be b e rigidly r i g i d l y segregated s e g r e g a t e d into i n t o two t w o layers. l a y e r s . In I n practice, p r a c t i c e , SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E are a r e often o f t e n outlined o u t l i n e d simultaneously s i m u l t a n e o u s l y and a n d the t h e SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s are a r e subsequently s u b s e q u e n t l y documented d o c u m e n t e d in i n a a layered l a y e r e d form. f o r m . B.5.3 B . 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o define d e f i n e the t h e major m a j o r structural s t r u c t u r a l components c o m p o n e n t s of o f the t h e software s o f t w a r e and a n d identify i d e n t i f y their t h e i r key k e y responsibilities, r e s p o n s i b i l i t i e s , their t h e i r externally e x t e r n a l l y visible v i s i b l e properties, p r o p e r t i e s , and a n d the t h e relationship r e l a t i o n s h i p among a m o n g them. t h e m . If I f the t h e behaviour b e h a v i o u r of o f a a component c o m p o n e n t can c a n affect a f f e c t other o t h e r components, c o m p o n e n t s , that t h a t behavior b e h a v i o r should s h o u l d be b e described d e s c r i b e d in i n the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . This T h i s description d e s c r i p t i o n is i s especially e s p e c i a l l y important i m p o r t a n t for f o r behaviour b e h a v i o u r that t h a t can c a n affect a f f e c t components c o m p o n e n t s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E that t h a t are a r e outside o u t s i d e the t h e software s o f t w a r e (see ( s e e 5.3.5 5 . 3 . 5 and a n d B.4.3). B . 4 . 3 ) . ARCHITECTURAL A R C H I T E C T U R A L decisions d e c i s i o n s are a r e extremely e x t r e m e l y important i m p o r t a n t for f o r implementing i m p l e m e n t i n g RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . Without W i t h o u t understanding u n d e r s t a n d i n g (and ( a n d documenting) d o c u m e n t i n g ) the t h e behaviour b e h a v i o u r of o f a a component c o m p o n e n t that t h a t can c a n affect a f f e c t other o t h e r components, c o m p o n e n t s , it i t will w i l l be b e nearly n e a r l y impossible i m p o s s i b l e to t o show s h o w that t h a t the t h e SYSTEM S Y S T E M is i s safe. s a f e . A A software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s necessary n e c e s s a r y to t o ensure e n s u r e the t h e correct c o r r e c t implementation i m p l e m e n t a t i o n of o f the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s not n o t complete c o m p l e t e unless u n l e s s all a l l software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e implemented i m p l e m e n t e d by b y the t h e identified i d e n t i f i e d SOFTWARE S O F T W A R E ITEMS. I T E M S . Because B e c a u s e the t h e design d e s i g n and a n d implementation i m p l e m e n t a t i o n of o f the t h e software s o f t w a r e is i s dependent d e p e n d e n t on o n the t h e ARCHITECTURE, A R C H I T E C T U R E , the t h e ARCHITECTURE A R C H I T E C T U R E is i s VERIFIED V E R I F I E D to t o complete c o m p l e t e this t h i s ACTIVITY. A C T I V I T Y . VERIFICATION V E R I F I C A T I O N of o f the t h e ARCHITECTURE A R C H I T E C T U R E is i s generally g e n e r a l l y done d o n e by b y technical t e c h n i c a l EVALUATION. E V A L U A T I O N . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S during d u r i n g the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E ACTIVITY A C T I V I T Y creates c r e a t e s a a basis b a s i s for f o r the t h e subsequent s u b s e q u e n t choice c h o i c e of o f software s o f t w a r e PROCESSES. P R O C E S S E S . The T h e records r e c o r d s of o f classification c l a s s i f i c a t i o n are a r e placed p l a c e d under u n d e r change c h a n g e control c o n t r o l as a s part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . Many M a n y subsequent s u b s e q u e n t events e v e n t s might m i g h t invalidate i n v a l i d a t e the t h e classification. c l a s s i f i c a t i o n . These T h e s e include, i n c l u d e , for f o r example: e x a m p l e : – – changes c h a n g e s of o f SYSTEM S Y S T E M specification, s p e c i f i c a t i o n , software s o f t w a r e specification s p e c i f i c a t i o n or o r ARCHITECTURE; A R C H I T E C T U R E ; – – discovery d i s c o v e r y of o f errors e r r o r s in i n the t h e RISK R I S K ANALYSIS, A N A L Y S I S , especially e s p e c i a l l y unforeseen u n f o r e s e e n HAZARDS; H A Z A R D S ; and a n d – – discovery d i s c o v e r y of o f the t h e infeasibility i n f e a s i b i l i t y of o f a a requirement, r e q u i r e m e n t , especially e s p e c i a l l y a a RISK R I S K CONTROL C O N T R O L measure; m e a s u r e ; Therefore, T h e r e f o r e , during d u r i n g all a l l ACTIVITIES A C T I V I T I E S following f o l l o w i n g the t h e design d e s i g n of o f the t h e software s o f t w a r e ARCHITECTURE, A R C H I T E C T U R E , the t h e classification c l a s s i f i c a t i o n of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e re-EVALUATED r e - E V A L U A T E D and a n d might m i g h t need n e e d to t o be b e revised. r e v i s e d . This T h i s would w o u l d trigger t r i g g e r rework r e w o r k to t o apply a p p l y additional a d d i t i o n a l PROCESSES P R O C E S S E S to t o a a SOFTWARE S O F T W A R E ITEM I T E M as a s a a result r e s u l t of o f its i t s upgrading u p g r a d i n g to t o a a higher h i g h e r class. c l a s s . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) is i s used u s e d to t o ensure e n s u r e that t h a t all a l l necessary n e c e s s a r y rework r e w o r k is i s identified i d e n t i f i e d and a n d completed. c o m p l e t e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5.4 B . 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o refine r e f i n e the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d interfaces i n t e r f a c e s defined d e f i n e d in i n the t h e ARCHITECTURE A R C H I T E C T U R E to t o create c r e a t e SOFTWARE S O F T W A R E UNITS U N I T S and a n d their t h e i r interfaces. i n t e r f a c e s . Although A l t h o u g h SOFTWARE S O F T W A R E UNITS U N I T S are a r e often o f t e n thought t h o u g h t of o f as a s being b e i n g a a single s i n g l e function f u n c t i o n or o r module, m o d u l e , this t h i s view v i e w is i s not n o t always a l w a y s appropriate. a p p r o p r i a t e . We W e have h a v e This T h i s standard s t a n d a r d has h a s defined d e f i n e d SOFTWARE S O F T W A R E UNIT U N I T to t o be b e a a SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s not n o t subdivided s u b d i v i d e d into i n t o smaller s m a l l e r items. i t e m s . SOFTWARE S O F T W A R E UNITS U N I T S can c a n be b e tested t e s t e d separately. s e p a r a t e l y . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d define d e f i n e the t h e level l e v e l of o f detail d e t a i l of o f the t h e SOFTWARE S O F T W A R E UNIT. U N I T . Detailed D e t a i l e d design d e s i g n specifies s p e c i f i e s algorithms, a l g o r i t h m s , data d a t a representations, r e p r e s e n t a t i o n s , interfaces i n t e r f a c e s among a m o n g different d i f f e r e n t SOFTWARE S O F T W A R E UNITS, U N I T S , and a n d interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E UNITS U N I T S and a n d data d a t a structures. s t r u c t u r e s . Detailed D e t a i l e d design d e s i g n must m u s t also a l s o be b e concerned c o n c e r n e d with w i t h the t h e packaging p a c k a g i n g of o f the t h e SOFTWARE S O F T W A R E PRODUCT. P R O D U C T . It I t is i s necessary n e c e s s a r y to t o document d o c u m e n t the t h e design d e s i g n of o f each e a c h SOFTWARE S O F T W A R E UNIT U N I T and a n d its i t s interface i n t e r f a c e so s o that t h a t the t h e SOFTWARE S O F T W A R E UNIT U N I T can c a n be b e implemented i m p l e m e n t e d correctly. c o r r e c t l y . The T h e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 51 5 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 detailed d e t a i l e d design d e s i g n fills f i l l s in i n the t h e details d e t a i l s necessary n e c e s s a r y to t o construct c o n s t r u c t the t h e software. s o f t w a r e . It I t is i s necessary n e c e s s a r y to t o define d e f i n e the t h e design d e s i g n of o f the t h e SOFTWARE S O F T W A R E UNITS U N I T S and a n d the t h e interfaces i n t e r f a c e s in i n sufficient s u f f i c i e n t detail d e t a i l to t o permit p e r m i t its i t s SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s to t o be b e objectively o b j e c t i v e l y VERIFIED V E R I F I E D where w h e r e this t h i s can c a n be b e ensured e n s u r e d using u s i n g other o t h e r requirements r e q u i r e m e n t s or o r design d e s i g n documentation. d o c u m e n t a t i o n . It I t should s h o u l d be b e complete c o m p l e t e enough e n o u g h that t h a t the t h e programmer p r o g r a m m e r is i s not n o t required r e q u i r e d to t o make m a k e ad a d hoc h o c design d e s i g n decisions. d e c i s i o n s . Detailed D e t a i l e d design d e s i g n must m u s t also a l s o be b e concerned c o n c e r n e d with w i t h the t h e architecture a r c h i t e c t u r e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . A A SOFTWARE S O F T W A R E ITEM I T E M can c a n be b e decomposed d e c o m p o s e d so s o that t h a t only o n l y a a few f e w of o f the t h e new n e w SOFTWARE S O F T W A R E ITEMS I T E M S implement i m p l e m e n t the t h e SAFETY-related S A F E T Y - r e l a t e d requirement r e q u i r e m e n t of o f the t h e original o r i g i n a l SOFTWARE S O F T W A R E ITEM. I T E M . The T h e remaining r e m a i n i n g SOFTWARE S O F T W A R E ITEMS I T E M S do d o not n o t implement i m p l e m e n t SAFETY-related S A F E T Y - r e l a t e d functions f u n c t i o n s and a n d can c a n be b e reclassified r e c l a s s i f i e d into i n t o a a lower l o w e r software s o f t w a r e safety s a f e t y class. c l a s s . However, H o w e v e r , the t h e decision d e c i s i o n to t o do d o this t h i s is i s in i n itself i t s e l f part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS, P R O C E S S , and a n d is i s documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . Because B e c a u s e implementation i m p l e m e n t a t i o n depends d e p e n d s on o n detailed d e t a i l e d design, d e s i g n , it i t is i s necessary n e c e s s a r y to t o verify v e r i f y the t h e detailed d e t a i l e d design d e s i g n before b e f o r e the t h e ACTIVITY A C T I V I T Y is i s complete. c o m p l e t e . VERIFICATION V E R I F I C A T I O N of o f detailed d e t a i l e d design d e s i g n is i s generally g e n e r a l l y done d o n e by b y a a technical t e c h n i c a l EVALUATION. E V A L U A T I O N . Subclause S u b c l a u s e 5.4.4 5 . 4 . 4 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e outputs o u t p u t s of o f the t h e detailed d e t a i l e d design d e s i g n ACTIVITIES. A C T I V I T I E S . The T h e design d e s i g n specifies s p e c i f i e s how h o w the t h e requirements r e q u i r e m e n t s are a r e to t o be b e implemented. i m p l e m e n t e d . VERIFICATION V E R I F I C A T I O N of o f the t h e design d e s i g n provides p r o v i d e s assurance a s s u r a n c e that t h a t it i t implements i m p l e m e n t s the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E and a n d is i s free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . If I f the t h e design d e s i g n contains c o n t a i n s defects, d e f e c t s , the t h e code c o d e will w i l l not n o t implement i m p l e m e n t the t h e requirements r e q u i r e m e n t s correctly. c o r r e c t l y . When W h e n present p r e s e n t in i n the t h e design, d e s i g n , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d verify v e r i f y design d e s i g n characteristics c h a r a c t e r i s t i c s which w h i c h the t h e MANUFACTURER M A N U F A C T U R E R believes b e l i e v e s are a r e important i m p o r t a n t for f o r SAFETY. S A F E T Y . Examples E x a m p l e s of o f these t h e s e characteristics c h a r a c t e r i s t i c s include: i n c l u d e : – – implementation i m p l e m e n t a t i o n of o f the t h e intended i n t e n d e d events, e v e n t s , inputs, i n p u t s , outputs, o u t p u t s , interfaces, i n t e r f a c e s , logic l o g i c flow, f l o w , allocation a l l o c a t i o n of o f CPU, C P U , allocation a l l o c a t i o n of o f memory m e m o r y resources, r e s o u r c e s , error e r r o r and a n d exception e x c e p t i o n definition, d e f i n i t i o n , error e r r o r and a n d exception e x c e p t i o n isolation, i s o l a t i o n , and a n d error e r r o r recovery; r e c o v e r y ; – – definition d e f i n i t i o n of o f the t h e default d e f a u l t state, s t a t e , in i n which w h i c h all a l l faults f a u l t s that t h a t can c a n result r e s u l t in i n a a hazardous h a z a r d o u s situation s i t u a t i o n are a r e addressed, a d d r e s s e d , with w i t h events e v e n t s and a n d transitions; t r a n s i t i o n s ; – – initialization i n i t i a l i z a t i o n of o f variables, v a r i a b l e s , memory m e m o r y management; m a n a g e m e n t ; and a n d – – cold c o l d and a n d warm w a r m resets, r e s e t s , standby, s t a n d b y , and a n d other o t h e r state s t a t e changes c h a n g e s that t h a t can c a n affect a f f e c t the t h e RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . B.5.5 B . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o write w r i t e and a n d verify v e r i f y the t h e code c o d e for f o r the t h e SOFTWARE S O F T W A R E UNITS. U N I T S . The T h e detailed d e t a i l e d design d e s i g n is i s to t o be b e translated t r a n s l a t e d into i n t o source s o u r c e code. c o d e . Coding C o d i n g represents r e p r e s e n t s the t h e point p o i n t where w h e r e decomposition d e c o m p o s i t i o n of o f the t h e specifications s p e c i f i c a t i o n s ends e n d s and a n d composition c o m p o s i t i o n of o f the t h e executable e x e c u t a b l e software s o f t w a r e begins. b e g i n s . To T o consistently c o n s i s t e n t l y achieve a c h i e v e the t h e desirable d e s i r a b l e code c o d e characteristics, c h a r a c t e r i s t i c s , coding c o d i n g standards s t a n d a r d s should s h o u l d be b e used u s e d to t o specify s p e c i f y a a preferred p r e f e r r e d coding c o d i n g style. s t y l e . Examples E x a m p l e s of o f coding c o d i n g standards s t a n d a r d s include i n c l u d e requirements r e q u i r e m e n t s for f o r understandability, u n d e r s t a n d a b i l i t y , language l a n g u a g e usage u s a g e rules r u l e s or o r restrictions, r e s t r i c t i o n s , and a n d complexity c o m p l e x i t y management. m a n a g e m e n t . The T h e code c o d e for f o r each e a c h unit u n i t is i s VERIFIED V E R I F I E D to t o ensure e n s u r e that t h a t it i t functions f u n c t i o n s as a s specified s p e c i f i e d by b y the t h e detailed d e t a i l e d design d e s i g n and a n d that t h a t it i t complies c o m p l i e s with w i t h the t h e specified s p e c i f i e d coding c o d i n g standards. s t a n d a r d s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Subclause S u b c l a u s e 5.5.5 5 . 5 . 5 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e code. c o d e . If I f the t h e code c o d e does d o e s not n o t implement i m p l e m e n t the t h e design d e s i g n correctly, c o r r e c t l y , the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E will w i l l not n o t perform p e r f o r m as a s intended. i n t e n d e d . B.5.6 B . 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o plan p l a n and a n d execute e x e c u t e integration i n t e g r a t i o n of o f SOFTWARE S O F T W A R E UNITS U N I T S into i n t o aggregate a g g r e g a t e SOFTWARE S O F T W A R E ITEMS I T E M S as a s well w e l l as a s integration i n t e g r a t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S into i n t o higher h i g h e r aggregated a g g r e g a t e d SOFTWARE S O F T W A R E ITEMS I T E M S and a n d to t o verify v e r i f y that t h a t the t h e resulting r e s u l t i n g SOFTWARE S O F T W A R E ITEMS I T E M S behave b e h a v e as a s intended. i n t e n d e d . The T h e approach a p p r o a c h to t o integration i n t e g r a t i o n can c a n range r a n g e from f r o m non-incremental n o n - i n c r e m e n t a l integration i n t e g r a t i o n to t o any a n y form f o r m of o f incremental i n c r e m e n t a l integration. i n t e g r a t i o n . The T h e properties p r o p e r t i e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M being b e i n g assembled a s s e m b l e d dictate d i c t a t e the t h e chosen c h o s e n method m e t h o d of o f integration. i n t e g r a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 52 5 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g focuses f o c u s e s on o n the t h e transfer t r a n s f e r of o f data d a t a and a n d control c o n t r o l across a c r o s s a a SOFTWARE S O F T W A R E ITEM’s I T E M ’ s internal i n t e r n a l and a n d external e x t e r n a l interfaces. i n t e r f a c e s . External E x t e r n a l interfaces i n t e r f a c e s are a r e those t h o s e with w i t h other o t h e r software, s o f t w a r e , including i n c l u d i n g operating o p e r a t i n g system s y s t e m software, s o f t w a r e , and a n d MEDICAL M E D I C A L DEVICE D E V I C E hardware. h a r d w a r e . The T h e rigor r i g o r of o f integration i n t e g r a t i o n testing t e s t i n g and a n d the t h e level l e v e l of o f detail d e t a i l of o f the t h e documentation d o c u m e n t a t i o n associated a s s o c i a t e d with w i t h integration i n t e g r a t i o n testing t e s t i n g should s h o u l d be b e commensurate c o m m e n s u r a t e with w i t h the t h e RISK R I S K associated a s s o c i a t e d with w i t h the t h e device, d e v i c e , the t h e device’s d e v i c e ’ s dependence d e p e n d e n c e on o n software s o f t w a r e for f o r potentially p o t e n t i a l l y hazardous h a z a r d o u s functions, f u n c t i o n s , and a n d the t h e role r o l e of o f specific s p e c i f i c SOFTWARE S O F T W A R E ITEMS I T E M S in i n higher h i g h e r RISK R I S K device d e v i c e functions. f u n c t i o n s . For F o r example, e x a m p l e , although a l t h o u g h all a l l SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e tested, t e s t e d , items i t e m s that t h a t have h a v e an a n effect e f f e c t on o n SAFETY S A F E T Y should s h o u l d be b e subject s u b j e c t to t o more m o r e direct, d i r e c t , thorough, t h o r o u g h , and a n d detailed d e t a i l e d tests. t e s t s . As A s applicable, a p p l i c a b l e , integration i n t e g r a t i o n testing t e s t i n g demonstrates d e m o n s t r a t e s program p r o g r a m behaviour b e h a v i o u r at a t the t h e boundaries b o u n d a r i e s of o f its i t s input i n p u t and a n d output o u t p u t domains d o m a i n s and a n d confirms c o n f i r m s program p r o g r a m responses r e s p o n s e s to t o invalid, i n v a l i d , unexpected, u n e x p e c t e d , and a n d special s p e c i a l inputs. i n p u t s . The T h e program’s p r o g r a m ’ s actions a c t i o n s are a r e revealed r e v e a l e d when w h e n given g i v e n combinations c o m b i n a t i o n s of o f inputs i n p u t s or o r unexpected u n e x p e c t e d sequences s e q u e n c e s of o f inputs, i n p u t s , or o r when w h e n defined d e f i n e d timing t i m i n g requirements r e q u i r e m e n t s are a r e violated. v i o l a t e d . The T h e test t e s t requirements r e q u i r e m e n t s in i n the t h e plan p l a n should s h o u l d include, i n c l u d e , as a s appropriate, a p p r o p r i a t e , the t h e types t y p e s of o f white w h i t e box b o x testing t e s t i n g to t o be b e performed p e r f o r m e d as a s part p a r t of o f integration i n t e g r a t i o n testing. t e s t i n g . White W h i t e box b o x testing, t e s t i n g , also a l s o known k n o w n as a s glass g l a s s box, b o x , structural, s t r u c t u r a l , clear c l e a r box b o x and a n d open o p e n box b o x testing, t e s t i n g , is i s a a testing t e s t i n g technique t e c h n i q u e where w h e r e explicit e x p l i c i t knowledge k n o w l e d g e of o f the t h e internal i n t e r n a l workings w o r k i n g s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M being b e i n g tested t e s t e d are a r e used u s e d to t o select s e l e c t the t h e test t e s t data. d a t a . White W h i t e box b o x testing t e s t i n g uses u s e s specific s p e c i f i c knowledge k n o w l e d g e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M to t o examine e x a m i n e outputs. o u t p u t s . The T h e test t e s t is i s accurate a c c u r a t e only o n l y if i f the t h e tester t e s t e r knows k n o w s what w h a t the t h e SOFTWARE S O F T W A R E ITEM I T E M is i s supposed s u p p o s e d to t o do. d o . The T h e tester t e s t e r can c a n then t h e n see s e e if i f the t h e SOFTWARE S O F T W A R E ITEM I T E M diverges d i v e r g e s from f r o m its i t s intended i n t e n d e d goal. g o a l . White W h i t e box b o x testing t e s t i n g cannot c a n n o t guarantee g u a r a n t e e that t h a t the t h e complete c o m p l e t e specification s p e c i f i c a t i o n has h a s been b e e n implemented i m p l e m e n t e d since s i n c e it i t is i s focused f o c u s e d on o n testing t e s t i n g the t h e implementation i m p l e m e n t a t i o n of o f the t h e SOFTWARE S O F T W A R E ITEM. I T E M . Black B l a c k box b o x testing, t e s t i n g , also a l s o known k n o w n as a s behavioural, b e h a v i o u r a l , functional, f u n c t i o n a l , opaque-box, o p a q u e - b o x , and a n d closed-box c l o s e d - b o x testing, t e s t i n g , is i s focused f o c u s e d on o n testing t e s t i n g the t h e functional f u n c t i o n a l specification s p e c i f i c a t i o n and a n d it i t cannot c a n n o t guarantee g u a r a n t e e that t h a t all a l l parts p a r t s of o f the t h e implementation i m p l e m e n t a t i o n have h a v e been b e e n tested. t e s t e d . Thus T h u s black b l a c k box b o x testing t e s t i n g is i s testing t e s t i n g against a g a i n s t the t h e specification s p e c i f i c a t i o n and a n d will w i l l discover d i s c o v e r faults f a u l t s of o f omission, o m i s s i o n , indicating i n d i c a t i n g that t h a t part p a r t of o f the t h e specification s p e c i f i c a t i o n has h a s not n o t been b e e n fulfilled. f u l f i l l e d . White W h i t e box b o x testing t e s t i n g is i s testing t e s t i n g against a g a i n s t the t h e implementation i m p l e m e n t a t i o n and a n d will w i l l discover d i s c o v e r faults f a u l t s of o f commission, c o m m i s s i o n , indicating i n d i c a t i n g that t h a t part p a r t of o f the t h e implementation i m p l e m e n t a t i o n is i s faulty. f a u l t y . In I n order o r d e r to t o fully f u l l y test t e s t a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT P R O D U C T both b o t h black b l a c k and a n d white w h i t e box b o x testing t e s t i n g might m i g h t be b e required. r e q u i r e d . The T h e plans p l a n s and a n d test t e s t documentation d o c u m e n t a t i o n identified i d e n t i f i e d in i n 5.6 5 . 6 and a n d 5.7 5 . 7 can c a n be b e individual i n d i v i d u a l documents d o c u m e n t s tied t i e d to t o specific s p e c i f i c phases p h a s e s of o f development d e v e l o p m e n t or o r evolutionary e v o l u t i o n a r y prototypes. p r o t o t y p e s . They T h e y also a l s o might m i g h t be b e combined c o m b i n e d so s o a a single s i n g l e document d o c u m e n t or o r set s e t of o f documents d o c u m e n t s covers c o v e r s the t h e requirements r e q u i r e m e n t s of o f multiple m u l t i p l e subsections. s u b s e c t i o n s . All A l l or o r portions p o r t i o n s of o f the t h e documents d o c u m e n t s could c o u l d be b e incorporated i n c o r p o r a t e d into i n t o higher h i g h e r level l e v e l project p r o j e c t documents d o c u m e n t s such s u c h as a s a a software s o f t w a r e or o r project p r o j e c t quality q u a l i t y assurance a s s u r a n c e plan p l a n or o r a a comprehensive c o m p r e h e n s i v e test t e s t plan p l a n that t h a t addresses a d d r e s s e s all a l l aspects a s p e c t s of o f testing t e s t i n g for f o r hardware h a r d w a r e and a n d software. s o f t w a r e . In I n these t h e s e cases, c a s e s , a a cross c r o s s reference r e f e r e n c e should s h o u l d be b e created c r e a t e d that t h a t identifies i d e n t i f i e s how h o w the t h e various v a r i o u s project p r o j e c t documents d o c u m e n t s relate r e l a t e to t o each e a c h of o f the t h e software s o f t w a r e integration i n t e g r a t i o n TASKS. T A S K S . Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g can c a n be b e performed p e r f o r m e d in i n a a simulated s i m u l a t e d environment, e n v i r o n m e n t , on o n actual a c t u a l target t a r g e t hardware, h a r d w a r e , or o r on o n the t h e full f u l l MEDICAL M E D I C A L DEVICE. D E V I C E . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Subclause S u b c l a u s e 5.6.2 5 . 6 . 2 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e output o u t p u t of o f the t h e software s o f t w a r e integration i n t e g r a t i o n ACTIVITY. A C T I V I T Y . The T h e output o u t p u t of o f the t h e software s o f t w a r e integration i n t e g r a t i o n ACTIVITY A C T I V I T Y is i s the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS. I T E M S . These T h e s e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS I T E M S must m u s t function f u n c t i o n properly p r o p e r l y for f o r the t h e entire e n t i r e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E to t o function f u n c t i o n correctly c o r r e c t l y and a n d safely. s a f e l y . B.5.7 B . 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e software’s s o f t w a r e ’ s functionality f u n c t i o n a l i t y by b y verifying v e r i f y i n g that t h a t the t h e requirements r e q u i r e m e n t s for f o r the t h e software s o f t w a r e have h a v e been b e e n successfully s u c c e s s f u l l y implemented. i m p l e m e n t e d . SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g demonstrates d e m o n s t r a t e s that t h a t the t h e specified s p e c i f i e d functionality f u n c t i o n a l i t y exists. e x i s t s . This T h i s testing t e s t i n g VERIFIES V E R I F I E S the t h e functionality f u n c t i o n a l i t y and a n d performance p e r f o r m a n c e of o f the t h e program p r o g r a m as a s built b u i l t with w i t h respect r e s p e c t to t o the t h e requirements r e q u i r e m e n t s for f o r the t h e software. s o f t w a r e . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 53 5 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g focuses f o c u s e s on o n functional f u n c t i o n a l (black ( b l a c k box) b o x ) testing, t e s t i n g , although a l t h o u g h it i t might m i g h t be b e desirable d e s i r a b l e to t o use u s e white w h i t e box b o x (see ( s e e previous p r e v i o u s section) s e c t i o n ) methods m e t h o d s to t o more m o r e efficiently e f f i c i e n t l y accomplish a c c o m p l i s h certain c e r t a i n tests, t e s t s , initiate i n i t i a t e stress s t r e s s conditions c o n d i t i o n s or o r faults, f a u l t s , or o r increase i n c r e a s e code c o d e coverage c o v e r a g e of o f the t h e qualification q u a l i f i c a t i o n tests. t e s t s . The T h e organization o r g a n i z a t i o n of o f testing t e s t i n g by b y types t y p e s and a n d test t e s t stage s t a g e is i s flexible, f l e x i b l e , but b u t coverage c o v e r a g e of o f requirements, r e q u i r e m e n t s , RISK R I S K CONTROL, C O N T R O L , usability, u s a b i l i t y , and a n d test t e s t types t y p e s (e.g., ( e . g . , fault, f a u l t , installation, i n s t a l l a t i o n , stress) s t r e s s ) should s h o u l d be b e demonstrated d e m o n s t r a t e d and a n d documented. d o c u m e n t e d . SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g tests t e s t s the t h e integrated i n t e g r a t e d software s o f t w a r e and a n d can c a n be b e performed p e r f o r m e d in i n a a simulated s i m u l a t e d environment, e n v i r o n m e n t , on o n actual a c t u a l target t a r g e t hardware, h a r d w a r e , or o r on o n the t h e full f u l l MEDICAL M E D I C A L DEVICE. D E V I C E . When W h e n a a change c h a n g e is i s made m a d e to t o a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (even ( e v e n a a small s m a l l change), c h a n g e ) , the t h e degree d e g r e e of o f REGRESSION R E G R E S S I O N TESTING T E S T I N G (not ( n o t just j u s t the t h e testing t e s t i n g of o f the t h e individual i n d i v i d u a l change) c h a n g e ) should s h o u l d be b e determined d e t e r m i n e d to t o ensure e n s u r e that t h a t no n o unintended u n i n t e n d e d side s i d e effects e f f e c t s have h a v e been b e e n introduced. i n t r o d u c e d . This T h i s REGRESSION R E G R E S S I O N TESTING T E S T I N G (and ( a n d the t h e rationale r a t i o n a l e for f o r not n o t fully f u l l y repeating r e p e a t i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing) t e s t i n g ) should s h o u l d be b e planned p l a n n e d and a n d documented. d o c u m e n t e d . (See ( S e e B.6.3). B . 6 . 3 ) . SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t responsibilities r e s p o n s i b i l i t i e s can c a n be b e dispersed, d i s p e r s e d , occurring o c c u r r i n g at a t different d i f f e r e n t locations l o c a t i o n s and a n d being b e i n g conducted c o n d u c t e d by b y different d i f f e r e n t organizations. o r g a n i z a t i o n s . However, H o w e v e r , regardless r e g a r d l e s s of o f the t h e distribution d i s t r i b u t i o n of o f TASKS, T A S K S , contractual c o n t r a c t u a l relations, r e l a t i o n s , source s o u r c e of o f components, c o m p o n e n t s , or o r development d e v e l o p m e n t environment, e n v i r o n m e n t , the t h e device d e v i c e MANUFACTURER M A N U F A C T U R E R retains r e t a i n s ultimate u l t i m a t e responsibility r e s p o n s i b i l i t y for f o r ensuring e n s u r i n g that t h a t the t h e software s o f t w a r e functions f u n c t i o n s properly p r o p e r l y for f o r its i t s intended i n t e n d e d use. u s e . If I f ANOMALIES A N O M A L I E S uncovered u n c o v e r e d during d u r i n g testing t e s t i n g can c a n be b e repeated, r e p e a t e d , but b u t a a decision d e c i s i o n has h a s been b e e n made m a d e not n o t to t o fix f i x them, t h e m , then t h e n these t h e s e ANOMALIES A N O M A L I E S need n e e d to t o be b e EVALUATED E V A L U A T E D in i n relation r e l a t i o n to t o the t h e HAZARD H A Z A R D RISK R I S K analysis a n a l y s i s to t o verify v e r i f y that t h a t they t h e y do d o not n o t affect a f f e c t the t h e SAFETY S A F E T Y of o f the t h e device. d e v i c e . The T h e root r o o t cause c a u s e and a n d symptoms s y m p t o m s of o f the t h e ANOMALIES A N O M A L I E S should s h o u l d be b e understood, u n d e r s t o o d , and a n d the t h e rationale r a t i o n a l e for f o r not n o t fixing f i x i n g them t h e m should s h o u l d be b e documented. d o c u m e n t e d . Subclause S u b c l a u s e 5.7.4 5 . 7 . 4 requires r e q u i r e s the t h e results r e s u l t s of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g be b e EVALUATED E V A L U A T E D to t o ensure e n s u r e that t h a t the t h e expected e x p e c t e d results r e s u l t s were w e r e obtained. o b t a i n e d . B.5.8 B . 5 . 8 Software S o f t w a r e release r e l e a s e This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E being b e i n g released, r e l e a s e d , specify s p e c i f y how h o w it i t was w a s created, c r e a t e d , and a n d follow f o l l o w appropriate a p p r o p r i a t e procedures p r o c e d u r e s for f o r release r e l e a s e of o f the t h e software. s o f t w a r e . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d be b e able a b l e to t o show s h o w that t h a t the t h e software s o f t w a r e that t h a t was w a s developed d e v e l o p e d using u s i n g the t h e development d e v e l o p m e n t PROCESS P R O C E S S is i s the t h e software s o f t w a r e that t h a t is i s being b e i n g released. r e l e a s e d . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d also a l s o be b e able a b l e to t o retrieve r e t r i e v e the t h e software s o f t w a r e and a n d the t h e tools t o o l s used u s e d for f o r its i t s generation g e n e r a t i o n in i n case c a s e it i t is i s needed n e e d e d in i n the t h e future f u t u r e and a n d should s h o u l d store, s t o r e , package, p a c k a g e , and a n d deliver d e l i v e r the t h e software s o f t w a r e in i n a a manner m a n n e r that t h a t minimizes m i n i m i z e s the t h e software s o f t w a r e from f r o m being b e i n g damaged d a m a g e d or o r misused. m i s u s e d . Defined D e f i n e d procedures p r o c e d u r e s should s h o u l d be b e established e s t a b l i s h e d to t o ensure e n s u r e that t h a t these t h e s e TASKS T A S K S are a r e performed p e r f o r m e d appropriately a p p r o p r i a t e l y and a n d with w i t h consistent c o n s i s t e n t results. r e s u l t s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.6 B . 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S B.6.1 B . 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S differs d i f f e r s from f r o m the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S in i n two t w o ways: w a y s : – – The T h e MANUFACTURER M A N U F A C T U R E R is i s permitted p e r m i t t e d to t o use u s e a a smaller s m a l l e r PROCESS P R O C E S S than t h a n the t h e full f u l l software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S to t o implement i m p l e m e n t rapid r a p i d changes c h a n g e s in i n response r e s p o n s e to t o urgent u r g e n t problems. p r o b l e m s . – – In I n responding r e s p o n d i n g to t o software s o f t w a r e PROBLEMS P R O B L E M S REPORTS R E P O R T S relating r e l a t i n g to t o released r e l e a s e d product, p r o d u c t , the t h e MANUFACTURER M A N U F A C T U R E R not n o t only o n l y addresses a d d r e s s e s the t h e problem p r o b l e m but b u t also a l s o satisfies s a t i s f i e s local l o c a l regulations r e g u l a t i o n s (typically ( t y p i c a l l y by b y running r u n n i n g a a pro-active p r o - a c t i v e surveillance s u r v e i l l a n c e scheme s c h e m e for f o r collecting c o l l e c t i n g problem p r o b l e m data d a t a from f r o m the t h e field f i e l d and a n d communicating c o m m u n i c a t i n g with w i t h users u s e r s and a n d regulators r e g u l a t o r s about a b o u t the t h e problem). p r o b l e m ) . Subclause S u b c l a u s e 6.1 6 . 1 requires r e q u i r e s these t h e s e PROCESSES P R O C E S S E S to t o be b e established e s t a b l i s h e d in i n a a maintenance m a i n t e n a n c e plan. p l a n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 54 5 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o create c r e a t e or o r identify i d e n t i f y procedures p r o c e d u r e s for f o r implementing i m p l e m e n t i n g maintenance m a i n t e n a n c e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . To T o implement i m p l e m e n t corrective c o r r e c t i v e actions, a c t i o n s , control c o n t r o l changes c h a n g e s during d u r i n g maintenance, m a i n t e n a n c e , and a n d manage m a n a g e release r e l e a s e of o f revised r e v i s e d software, s o f t w a r e , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d document d o c u m e n t and a n d resolve r e s o l v e reported r e p o r t e d problems p r o b l e m s and a n d requests r e q u e s t s from f r o m users, u s e r s , as a s well w e l l as a s manage m a n a g e modifications m o d i f i c a t i o n s to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s PROCESS P R O C E S S is i s activated a c t i v a t e d when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E undergoes u n d e r g o e s modifications m o d i f i c a t i o n s to t o code c o d e and a n d associated a s s o c i a t e d documentation d o c u m e n t a t i o n because b e c a u s e of o f either e i t h e r a a problem p r o b l e m or o r the t h e need n e e d for f o r improvement i m p r o v e m e n t or o r adaptation. a d a p t a t i o n . The T h e objective o b j e c t i v e is i s to t o modify m o d i f y released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E while w h i l e preserving p r e s e r v i n g its i t s integrity. i n t e g r i t y . This T h i s PROCESS P R O C E S S includes i n c l u d e s migration m i g r a t i o n of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E to t o environments e n v i r o n m e n t s or o r platforms p l a t f o r m s for f o r which w h i c h it i t was w a s not n o t originally o r i g i n a l l y released. r e l e a s e d . The T h e ACTIVITIES A C T I V I T I E S provided p r o v i d e d in i n this t h i s clause c l a u s e are a r e specific s p e c i f i c to t o the t h e maintenance m a i n t e n a n c e PROCESS; P R O C E S S ; however, h o w e v e r , the t h e maintenance m a i n t e n a n c e PROCESS P R O C E S S might m i g h t use u s e other o t h e r PROCESSES P R O C E S S E S in i n this t h i s standard. s t a n d a r d . The T h e MANUFACTURER M A N U F A C T U R E R needs n e e d s to t o plan p l a n how h o w the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e maintenance m a i n t e n a n c e PROCESS P R O C E S S will w i l l be b e performed. p e r f o r m e d . B.6.2 B . 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o analyze a n a l y z e feedback f e e d b a c k for f o r its i t s effect; e f f e c t ; verify v e r i f y reported r e p o r t e d problems; p r o b l e m s ; and a n d consider, c o n s i d e r , select, s e l e c t , and a n d obtain o b t a i n approval a p p r o v a l for f o r implementing i m p l e m e n t i n g a a modification m o d i f i c a t i o n option. o p t i o n . Problems P r o b l e m s and a n d other o t h e r requests r e q u e s t s for f o r changes c h a n g e s can c a n affect a f f e c t the t h e performance, p e r f o r m a n c e , SAFETY, S A F E T Y , or o r regulatory r e g u l a t o r y clearance c l e a r a n c e of o f a a MEDICAL M E D I C A L DEVICE. D E V I C E . An A n analysis a n a l y s i s is i s necessary n e c e s s a r y to t o determine d e t e r m i n e whether w h e t h e r any a n y effects e f f e c t s exist e x i s t because b e c a u s e of o f a a PROBLEM P R O B L E M REPORT R E P O R T or o r whether w h e t h e r any a n y effects e f f e c t s will w i l l result r e s u l t from f r o m a a modification m o d i f i c a t i o n to t o correct c o r r e c t a a problem p r o b l e m or o r implement i m p l e m e n t a a request. r e q u e s t . It I t is i s especially e s p e c i a l l y important i m p o r t a n t to t o verify v e r i f y through t h r o u g h trace t r a c e or o r regression r e g r e s s i o n analysis a n a l y s i s that t h a t the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s built b u i l t into i n t o the t h e device d e v i c e are a r e not n o t adversely a d v e r s e l y changed c h a n g e d or o r modified m o d i f i e d by b y the t h e software s o f t w a r e change c h a n g e that t h a t is i s being b e i n g implemented i m p l e m e n t e d as a s part p a r t of o f the t h e software s o f t w a r e maintenance m a i n t e n a n c e ACTIVITY. A C T I V I T Y . It I t is i s also a l s o important i m p o r t a n t to t o verify v e r i f y that t h a t the t h e modified m o d i f i e d software s o f t w a r e does d o e s not n o t cause c a u s e a a HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N or o r mitigate m i t i g a t e a a RISK R I S K in i n software s o f t w a r e that t h a t previously p r e v i o u s l y did d i d not n o t cause c a u s e a a HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N or o r mitigate m i t i g a t e RISKS. R I S K S . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f a a SOFTWARE S O F T W A R E ITEM I T E M might m i g h t have h a v e changed c h a n g e d if i f the t h e software s o f t w a r e modification m o d i f i c a t i o n now n o w can c a n cause c a u s e a a HAZARD H A Z A R D or o r mitigate m i t i g a t e a a RISK. R I S K . It I t is i s important i m p o r t a n t to t o distinguish d i s t i n g u i s h between b e t w e e n software s o f t w a r e maintenance m a i n t e n a n c e (Clause ( C l a u s e 6) 6 ) and a n d software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n (Clause ( C l a u s e 9). 9 ) . The T h e focus f o c u s of o f the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s an a n adequate a d e q u a t e response r e s p o n s e to t o feedback f e e d b a c k arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCT. P R O D U C T . As A s part p a r t of o f a a MEDICAL M E D I C A L DEVICE, D E V I C E , the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S needs n e e d s to t o ensure e n s u r e that: t h a t : – – SAFETY-related S A F E T Y - r e l a t e d PROBLEM P R O B L E M REPORTS R E P O R T S are a r e addressed a d d r e s s e d and a n d reported r e p o r t e d to t o appropriate a p p r o p r i a t e regulatory r e g u l a t o r y authorities a u t h o r i t i e s and a n d affected a f f e c t e d users; u s e r s ; – – MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S are a r e is i s re-validated r e - v a l i d a t e d and a n d re-released r e - r e l e a s e d after a f t e r modification m o d i f i c a t i o n with w i t h formal f o r m a l controls c o n t r o l s that t h a t ensure e n s u r e the t h e rectification r e c t i f i c a t i o n of o f the t h e problem p r o b l e m and a n d the t h e avoidance a v o i d a n c e of o f further f u r t h e r problems; p r o b l e m s ; – – the t h e MANUFACTURER M A N U F A C T U R E R considers c o n s i d e r s what w h a t other o t h e r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E PRODUCTS P R O D U C T S might m i g h t be b e affected a f f e c t e d and a n d takes t a k e s appropriate a p p r o p r i a t e action. a c t i o n . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e focus f o c u s of o f software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n is i s the t h e operation o p e r a t i o n of o f a a comprehensive c o m p r e h e n s i v e control c o n t r o l system s y s t e m that: t h a t : � analyses a n a l y s e s PROBLEM P R O B L E M REPORTS R E P O R T S and a n d identifies i d e n t i f i e s all a l l the t h e implications i m p l i c a t i o n s of o f the t h e problem; p r o b l e m ; decides d e c i d e s on o n a a number n u m b e r of o f changes c h a n g e s and a n d identifies i d e n t i f i e s all a l l their t h e i r side-effects; s i d e - e f f e c t s ; � implements i m p l e m e n t s the t h e changes c h a n g e s while w h i l e maintaining m a i n t a i n i n g the t h e consistency c o n s i s t e n c y of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S including i n c l u d i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE; F I L E ; � VERIFIES V E R I F I E S the t h e implementation i m p l e m e n t a t i o n of o f the t h e changes. c h a n g e s . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S uses u s e s the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S handles h a n d l e s the t h e high-level h i g h - l e v e l decisions d e c i s i o n s about a b o u t the t h e PROBLEM P R O B L E M REPORT R E P O R T (whether ( w h e t h e r a a problem p r o b l e m exists, e x i s t s , whether w h e t h e r it i t has h a s a a significant s i g n i f i c a n t effect e f f e c t on o n SAFETY, S A F E T Y , what w h a t changes c h a n g e s are a r e needed n e e d e d and a n d when w h e n to t o implement i m p l e m e n t them), t h e m ) , and a n d uses u s e s the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S to t o analyse a n a l y s e the t h e PROBLEM P R O B L E M REPORT R E P O R T to t o discover d i s c o v e r all a l l the t h e implications i m p l i c a t i o n s and a n d to t o generate g e n e r a t e possible p o s s i b l e CHANGE C H A N G E granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 55 5 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 REQUESTS R E Q U E S T S which w h i c h identify i d e n t i f y all a l l the t h e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S that t h a t need n e e d to t o be b e changed c h a n g e d and a n d all a l l the t h e VERIFICATION V E R I F I C A T I O N steps s t e p s that t h a t are a r e necessary. n e c e s s a r y . B.6.3 B . 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R use u s e an a n established e s t a b l i s h e d PROCESS P R O C E S S to t o make m a k e the t h e modification. m o d i f i c a t i o n . If I f a a maintenance m a i n t e n a n c e PROCESS P R O C E S S has h a s not n o t been b e e n defined, d e f i n e d , the t h e appropriate a p p r o p r i a t e development d e v e l o p m e n t PROCESS P R O C E S S TASKS T A S K S can c a n be b e used u s e d to t o make m a k e the t h e modification. m o d i f i c a t i o n . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d also a l s o ensure e n s u r e that t h a t the t h e modification m o d i f i c a t i o n does d o e s not n o t cause c a u s e a a negative n e g a t i v e effect e f f e c t on o n other o t h e r parts p a r t s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Unless U n l e s s the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s treated t r e a t e d as a s a a new n e w development, d e v e l o p m e n t , analysis a n a l y s i s of o f the t h e effect e f f e c t of o f a a modification m o d i f i c a t i o n on o n the t h e entire e n t i r e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s necessary. n e c e s s a r y . Regression R e g r e s s i o n analysis a n a l y s i s and a n d testing t e s t i n g are a r e employed e m p l o y e d to t o provide p r o v i d e assurance a s s u r a n c e that t h a t a a change c h a n g e has h a s not n o t created c r e a t e d problems p r o b l e m s elsewhere e l s e w h e r e in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Regression R e g r e s s i o n analysis a n a l y s i s is i s the t h e determination d e t e r m i n a t i o n of o f the t h e impact i m p a c t of o f a a change c h a n g e based b a s e d on o n review r e v i e w of o f the t h e relevant r e l e v a n t documentation d o c u m e n t a t i o n (e.g., ( e . g . , software s o f t w a r e requirements r e q u i r e m e n t s specification, s p e c i f i c a t i o n , software s o f t w a r e design d e s i g n specification, s p e c i f i c a t i o n , source s o u r c e code, c o d e , test t e s t plans, p l a n s , test t e s t cases, c a s e s , test t e s t scripts, s c r i p t s , etc.) e t c . ) in i n order o r d e r to t o identify i d e n t i f y the t h e necessary n e c e s s a r y regression r e g r e s s i o n tests t e s t s to t o be b e run. r u n . Regression R e g r e s s i o n testing t e s t i n g is i s the t h e rerunning r e r u n n i n g of o f test t e s t cases c a s e s that t h a t a a program p r o g r a m has h a s previously p r e v i o u s l y executed e x e c u t e d correctly c o r r e c t l y and a n d comparing c o m p a r i n g the t h e current c u r r e n t result r e s u l t to t o the t h e previous p r e v i o u s result r e s u l t in i n order o r d e r to t o detect d e t e c t unintended u n i n t e n d e d effects e f f e c t s of o f a a software s o f t w a r e change. c h a n g e . A A rationale r a t i o n a l e must m u s t be b e made m a d e that t h a t justifies j u s t i f i e s the t h e amount a m o u n t of o f REGRESSION R E G R E S S I O N TESTING T E S T I N G that t h a t will w i l l be b e performed p e r f o r m e d to t o ensure e n s u r e that t h a t the t h e portions p o r t i o n s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E not n o t being b e i n g modified m o d i f i e d still s t i l l perform p e r f o r m as a s they t h e y did d i d before b e f o r e the t h e modification m o d i f i c a t i o n was w a s made. m a d e . B.7 B . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T is i s a a part p a r t of o f overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T and a n d cannot c a n n o t be b e adequately a d e q u a t e l y addressed a d d r e s s e d in i n isolation. i s o l a t i o n . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e use u s e of o f a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971. 1 4 9 7 1 . RISK R I S K MANAGEMENT M A N A G E M E N T as a s defined d e f i n e d in i n ISO I S O 14971 1 4 9 7 1 deals d e a l s specifically s p e c i f i c a l l y with w i t h a a framework f r a m e w o r k for f o r effective e f f e c t i v e management m a n a g e m e n t of o f the t h e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e use u s e of o f MEDICAL M E D I C A L DEVICES. D E V I C E S . One O n e portion p o r t i o n of o f ISO I S O 14971 1 4 9 7 1 pertains p e r t a i n s to t o control c o n t r o l of o f identified i d e n t i f i e d RISKS R I S K S associated a s s o c i a t e d with w i t h each e a c h HAZARD H A Z A R D identified i d e n t i f i e d during d u r i n g the t h e RISK R I S K ANALYSIS. A N A L Y S I S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d is i s intended i n t e n d e d to t o provide p r o v i d e additional a d d i t i o n a l requirements r e q u i r e m e n t s for f o r RISK R I S K CONTROL C O N T R O L for f o r software, s o f t w a r e , including i n c l u d i n g software s o f t w a r e that t h a t has h a s been b e e n identified i d e n t i f i e d during d u r i n g the t h e RISK R I S K ANALYSIS A N A L Y S I S as a s potentially p o t e n t i a l l y contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation, s i t u a t i o n , or o r software s o f t w a r e that t h a t is i s used u s e d to t o control c o n t r o l MEDICAL M E D I C A L DEVICE D E V I C E RISKS. R I S K S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S is i s included i n c l u d e d in i n this t h i s standard s t a n d a r d for f o r two t w o reasons. r e a s o n s . the t h e intended i n t e n d e d audience a u d i e n c e of o f this t h i s standard s t a n d a r d needs n e e d s to t o understand u n d e r s t a n d minimum m i n i m u m requirements r e q u i r e m e n t s for f o r RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n their t h e i r area a r e a of o f responsibility—software; r e s p o n s i b i l i t y — s o f t w a r e ; the t h e general g e n e r a l RISK R I S K MANAGEMENT M A N A G E M E N T standard, s t a n d a r d , ISO I S O 14971, 1 4 9 7 1 , provided p r o v i d e d as a s a a normative n o r m a t i v e reference r e f e r e n c e in i n this t h i s standard, s t a n d a r d , does d o e s not n o t specifically s p e c i f i c a l l y address a d d r e s s the t h e RISK R I S K CONTROL C O N T R O L of o f software s o f t w a r e and a n d the t h e placement p l a c e m e n t of o f RISK R I S K CONTROL C O N T R O L in i n the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle. c y c l e . Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T is i s a a part p a r t of o f overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT. M A N A G E M E N T . Plans, P l a n s , procedures, p r o c e d u r e s , and a n d documentation d o c u m e n t a t i o n required r e q u i r e d for f o r the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S can c a n be b e a a series s e r i e s of o f separate s e p a r a t e documents d o c u m e n t s or o r a a single s i n g l e document, d o c u m e n t , or o r they t h e y can c a n be b e integrated i n t e g r a t e d with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S and a n d documentation d o c u m e n t a t i o n as a s long l o n g as a s all a l l requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d are a r e met. m e t . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.7.1 B . 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s It I t is i s expected e x p e c t e d that t h a t the t h e device d e v i c e HAZARD H A Z A R D analysis a n a l y s i s will w i l l identify i d e n t i f y hazardous h a z a r d o u s situations s i t u a t i o n s and a n d corresponding c o r r e s p o n d i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o reduce r e d u c e the t h e probability p r o b a b i l i t y and/or a n d / o r severity s e v e r i t y of o f those t h o s e hazardous h a z a r d o u s situations s i t u a t i o n s to t o an a n acceptable a c c e p t a b l e level. l e v e l . It I t is i s also a l s o expected e x p e c t e d that t h a t the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s will w i l l be b e assigned a s s i g n e d to t o software s o f t w a r e functions f u n c t i o n s that t h a t are a r e expected e x p e c t e d to t o implement i m p l e m e n t those t h o s e RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 56 5 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 However, H o w e v e r , it i t is i s not n o t expected e x p e c t e d that t h a t all a l l device d e v i c e hazardous h a z a r d o u s situations s i t u a t i o n s can c a n be b e identified i d e n t i f i e d until u n t i l the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E has h a s been b e e n produced. p r o d u c e d . At A t that t h a t time t i m e it i t is i s known k n o w n how h o w software s o f t w a r e functions f u n c t i o n s will w i l l be b e implemented i m p l e m e n t e d in i n software s o f t w a r e components, c o m p o n e n t s , and a n d the t h e practicality p r a c t i c a l i t y of o f the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s assigned a s s i g n e d to t o software s o f t w a r e functions f u n c t i o n s can c a n be b e EVALUATED. E V A L U A T E D . At A t that t h a t time t i m e the t h e device d e v i c e HAZARD H A Z A R D analysis a n a l y s i s should s h o u l d be b e revised r e v i s e d to t o include: i n c l u d e : revised r e v i s e d hazardous h a z a r d o u s situations; s i t u a t i o n s ; � revised r e v i s e d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s and a n d software s o f t w a r e requirements; r e q u i r e m e n t s ; new n e w hazardous h a z a r d o u s situations s i t u a t i o n s arising a r i s i n g from f r o m software, s o f t w a r e , for f o r example e x a m p l e hazardous h a z a r d o u s situations s i t u a t i o n s related r e l a t e d to t o human h u m a n factors. f a c t o r s . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E should s h o u l d include i n c l u d e credible c r e d i b l e strategies s t r a t e g i e s for f o r segregating s e g r e g a t i n g software s o f t w a r e components c o m p o n e n t s so s o that t h a t they t h e y do d o not n o t interact i n t e r a c t in i n unsafe u n s a f e ways. w a y s . B.8 B . 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S is i s a a PROCESS P R O C E S S of o f applying a p p l y i n g administrative a d m i n i s t r a t i v e and a n d technical t e c h n i c a l procedures p r o c e d u r e s throughout t h r o u g h o u t the t h e software s o f t w a r e life l i f e cycle c y c l e to t o identify i d e n t i f y and a n d define d e f i n e SOFTWARE S O F T W A R E ITEMS, I T E M S , including i n c l u d i n g documentation, d o c u m e n t a t i o n , in i n a a SYSTEM; S Y S T E M ; control c o n t r o l modifications m o d i f i c a t i o n s and a n d releases r e l e a s e s of o f the t h e items; i t e m s ; and a n d document d o c u m e n t and a n d report r e p o r t the t h e status s t a t u s of o f the t h e items i t e m s and a n d CHANGE C H A N G E REQUESTS. R E Q U E S T S . Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t is i s necessary n e c e s s a r y to t o recreate r e c r e a t e a a SOFTWARE S O F T W A R E ITEM, I T E M , to t o identify i d e n t i f y its i t s constituent c o n s t i t u e n t parts, p a r t s , and a n d to t o provide p r o v i d e a a history h i s t o r y of o f the t h e changes c h a n g e s that t h a t have h a v e been b e e n made m a d e to t o it. i t . B.8.1 B . 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o uniquely u n i q u e l y identify i d e n t i f y software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS. V E R S I O N S . This T h i s identification i d e n t i f i c a t i o n is i s necessary n e c e s s a r y to t o identify i d e n t i f y the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d the t h e VERSIONS V E R S I O N S that t h a t are a r e included i n c l u d e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . B.8.2 B . 8 . 2 Change C h a n g e control c o n t r o l This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o control c o n t r o l changes c h a n g e s of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d to t o document d o c u m e n t information i n f o r m a t i o n identifying i d e n t i f y i n g CHANGE C H A N G E REQUESTS R E Q U E S T S and a n d providing p r o v i d i n g documentation d o c u m e n t a t i o n about a b o u t their t h e i r disposition. d i s p o s i t i o n . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t unauthorized u n a u t h o r i z e d or o r unintended u n i n t e n d e d changes c h a n g e s are a r e not n o t made m a d e to t o the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d to t o ensure e n s u r e that t h a t approved a p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S are a r e implemented i m p l e m e n t e d fully f u l l y and a n d verified. v e r i f i e d . CHANGE C H A N G E REQUESTS R E Q U E S T S can c a n be b e approved a p p r o v e d by b y a a change c h a n g e control c o n t r o l board b o a r d or o r by b y a a manager m a n a g e r or o r technical t e c h n i c a l lead l e a d according a c c o r d i n g to t o the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t plan. p l a n . Approved A p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S are a r e made m a d e traceable t r a c e a b l e to t o the t h e actual a c t u a l modification m o d i f i c a t i o n and a n d VERIFICATION V E R I F I C A T I O N of o f the t h e software. s o f t w a r e . The T h e requirement r e q u i r e m e n t is i s that t h a t each e a c h actual a c t u a l change c h a n g e be b e linked l i n k e d to t o a a CHANGE C H A N G E REQUEST R E Q U E S T and a n d that t h a t documentation d o c u m e n t a t i o n exists e x i s t s to t o show s h o w that t h a t the t h e CHANGE C H A N G E REQUEST R E Q U E S T was w a s approved. a p p r o v e d . The T h e documentation d o c u m e n t a t i o n might m i g h t be b e change c h a n g e control c o n t r o l board b o a r d minutes, m i n u t e s , an a n approval a p p r o v a l signature, s i g n a t u r e , or o r a a record r e c o r d in i n a a database. d a t a b a s e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.8.3 B . 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o maintain m a i n t a i n records r e c o r d s of o f the t h e history h i s t o r y of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS. I T E M S . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o determine d e t e r m i n e when w h e n and a n d why w h y changes c h a n g e s were w e r e made. m a d e . Access A c c e s s to t o this t h i s information i n f o r m a t i o n is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S contain c o n t a i n only o n l y authorized a u t h o r i z e d modifications. m o d i f i c a t i o n s . B.9 B . 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S is i s a a PROCESS P R O C E S S for f o r analyzing a n a l y z i n g and a n d resolving r e s o l v i n g the t h e problems p r o b l e m s (including ( i n c l u d i n g non-conformances), n o n - c o n f o r m a n c e s ) , whatever w h a t e v e r their t h e i r nature n a t u r e or o r source, s o u r c e , including i n c l u d i n g those t h o s e discovered d i s c o v e r e d during d u r i n g the t h e execution e x e c u t i o n of o f development, d e v e l o p m e n t , maintenance, m a i n t e n a n c e , or o r other o t h e r PROCESSES. P R O C E S S E S . The T h e objective o b j e c t i v e is i s to t o provide p r o v i d e a a timely, t i m e l y , responsible, r e s p o n s i b l e , and a n d documented d o c u m e n t e d means m e a n s to t o ensure e n s u r e that t h a t discovered d i s c o v e r e d problems p r o b l e m s are a r e analyzed a n a l y z e d and a n d resolved r e s o l v e d and a n d that t h a t trends t r e n d s are a r e recognized. r e c o g n i z e d . This T h i s PROCESS P R O C E S S is i s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 57 5 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 sometimes s o m e t i m e s called c a l l e d “defect “ d e f e c t tracking” t r a c k i n g ” in i n software s o f t w a r e engineering e n g i n e e r i n g literature. l i t e r a t u r e . It I t is i s called c a l l e d “problem “ p r o b l e m resolution” r e s o l u t i o n ” in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] and a n d IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 [2], [ 2 ] , Amendment A m e n d m e n t 1. 1 . We W e have h a v e chosen c h o s e n to t o call c a l l it i t “software “ s o f t w a r e problem p r o b l e m resolution” r e s o l u t i o n ” in i n this t h i s standard. s t a n d a r d . This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R use u s e the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S when w h e n a a problem p r o b l e m or o r non-conformance n o n - c o n f o r m a n c e is i s identified. i d e n t i f i e d . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t discovered d i s c o v e r e d problems p r o b l e m s are a r e analyzed a n a l y z e d and a n d EVALUATED E V A L U A T E D for f o r possible p o s s i b l e relevance r e l e v a n c e to t o SAFETY S A F E T Y (as ( a s specified s p e c i f i e d in i n ISO I S O 14971). 1 4 9 7 1 ) . Software S o f t w a r e development d e v e l o p m e n t plan(s) p l a n ( s ) or o r procedures, p r o c e d u r e s , as a s required r e q u i r e d in i n 5.1, 5 . 1 , are a r e to t o address a d d r e s s how h o w problems p r o b l e m s or o r non-conformances n o n - c o n f o r m a n c e s will w i l l be b e handled. h a n d l e d . This T h i s includes i n c l u d e s specifying s p e c i f y i n g at a t each e a c h stage s t a g e of o f the t h e life l i f e cycle c y c l e the t h e aspects a s p e c t s of o f the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S that t h a t will w i l l be b e formal f o r m a l and a n d documented d o c u m e n t e d as a s well w e l l as a s when w h e n problems p r o b l e m s and a n d nonconformities n o n c o n f o r m i t i e s are a r e to t o be b e entered e n t e r e d into i n t o the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 58 5 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x C C (informative) ( i n f o r m a t i v e ) Relationship R e l a t i o n s h i p to t o other o t h e r standards s t a n d a r d s C.1 C . 1 General G e n e r a l This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . The T h e software s o f t w a r e is i s considered c o n s i d e r e d a a subsystem s u b s y s t e m of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E or o r is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE. D E V I C E . This T h i s standard s t a n d a r d is i s to t o be b e used u s e d together t o g e t h e r with w i t h other o t h e r appropriate a p p r o p r i a t e standards s t a n d a r d s when w h e n developing d e v e l o p i n g a a MEDICAL M E D I C A L DEVICE. D E V I C E . MEDICAL M E D I C A L DEVICE D E V I C E management m a n a g e m e n t standards s t a n d a r d s such s u c h as a s ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] (see ( s e e C.2 C . 2 and a n d Annex A n n e x D) D ) and a n d ISO I S O 14971 1 4 9 7 1 (see ( s e e Annex A n n e x C.3) C . 3 ) provide p r o v i d e a a management m a n a g e m e n t environment e n v i r o n m e n t that t h a t lays l a y s a a foundation f o u n d a t i o n for f o r an a n organization o r g a n i z a t i o n to t o develop d e v e l o p products. p r o d u c t s . Safety S a f e t y standards s t a n d a r d s such s u c h as a s IEC I E C 60601-1 6 0 6 0 1 - 1 [1] [ 1 ] (see ( s e e Annex A n n e x C.4) C . 4 ) and a n d IEC I E C 61010-1 6 1 0 1 0 - 1 [5] [ 5 ] (see ( s e e Annex A n n e x C.5) C . 5 ) give g i v e specific s p e c i f i c direction d i r e c t i o n for f o r creating c r e a t i n g safe s a f e MEDICAL M E D I C A L DEVICES. D E V I C E S . When W h e n software s o f t w a r e is i s a a part p a r t of o f these t h e s e MEDICAL M E D I C A L DEVICES, D E V I C E S , IEC I E C 62304 6 2 3 0 4 provides p r o v i d e s more m o r e detailed d e t a i l e d direction d i r e c t i o n on o n what w h a t is i s required r e q u i r e d to t o develop d e v e l o p and a n d maintain m a i n t a i n safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Many M a n y other o t h e r standards s t a n d a r d s such s u c h as a s ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] (see ( s e e Annex A n n e x C.6), C . 6 ) , IEC I E C 61508-3 6 1 5 0 8 - 3 [4] [ 4 ] (see ( s e e Annex A n n e x C.7) C . 7 ) and a n d ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15] [ 1 5 ] can c a n be b e looked l o o k e d to t o as a s a a source s o u r c e of o f methods, m e t h o d s , tools t o o l s and a n d techniques t e c h n i q u e s that t h a t can c a n be b e used u s e d to t o implement i m p l e m e n t the t h e requirements r e q u i r e m e n t s in i n IEC I E C 62304. 6 2 3 0 4 . Figure F i g u r e C.1 C . 1 shows s h o w s the t h e relationship r e l a t i o n s h i p of o f these t h e s e standards. s t a n d a r d s . Where W h e r e clauses c l a u s e s or o r requirements r e q u i r e m e n t s from f r o m other o t h e r standards s t a n d a r d s are a r e quoted, q u o t e d , defined d e f i n e d terms t e r m s in i n the t h e quoted q u o t e d items i t e m s are a r e terms t e r m s that t h a t are a r e defined d e f i n e d in i n the t h e other o t h e r standard, s t a n d a r d , not n o t defined d e f i n e d terms t e r m s in i n this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 59 5 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Medical M e d i c a l device d e v i c e management m a n a g e m e n t Lays L a y s standards s t a n d a r d s out o u t a a foundation f o u n d a t i o n ISO I S O 14971 1 4 9 7 1 to t o develop d e v e l o p a a medical m e d i c a l device d e v i c e ISO I S O 13485 1 3 4 8 5 Medical M e d i c a l device d e v i c e product p r o d u c t standards s t a n d a r d s IEC I E C 60601-1, 6 0 6 0 1 - 1 , affects a f f e c t s affects a f f e c t s IEC I E C 61010-1 6 1 0 1 0 - 1 requires r e q u i r e s Medical M e d i c a l device d e v i c e process p r o c e s s standard s t a n d a r d IEC I E C Implementation I m p l e m e n t a t i o n 62304 6 2 3 0 4 of o f medical m e d i c a l device d e v i c e software s o f t w a r e affects a f f e c t s Gives G i v e s detailed d e t a i l e d direction d i r e c t i o n how h o w to t o develop d e v e l o p and a n d maintain m a i n t a i n safe s a f e software s o f t w a r e system s y s t e m Other O t h e r sources s o u r c e s of o f information i n f o r m a t i o n IEC/ISO I E C / I S O 12207, 1 2 2 0 7 , IEC I E C 61508-3, 6 1 5 0 8 - 3 , IEC/ISO I E C / I S O 90003, 9 0 0 0 3 , ... . . . inspires i n s p i r e s Gives G i v e s additional a d d i t i o n a l guidelines, g u i d e l i n e s , techniques, t e c h n i q u e s , etc e t c that t h a t may m a y be b e used u s e d Medical M e d i c a l device d e v i c e management m a n a g e m e n t Lays L a y s standards s t a n d a r d s out o u t a a foundation f o u n d a t i o n ISO I S O 14971 1 4 9 7 1 to t o ISO I S O 13485 1 3 4 8 5 develop d e v e l o p a a medical m e d i c a l device d e v i c e requires r e q u i r e s affects a f f e c t s Medical M e d i c a l device d e v i c e process p r o c e s s standards s t a n d a r d s IEC I E C 62304 6 2 3 0 4 IEC I E C 62366-1 6 2 3 6 6 - 1 affects a f f e c t s Implementation I m p l e m e n t a t i o n of o f medical m e d i c a l device d e v i c e software s o f t w a r e affects a f f e c t s Gives G i v e s specific s p e c i f i c direction d i r e c t i o n for f o r creation c r e a t i o n of o f a a safe s a f e medical m e d i c a l Medical M e d i c a l device d e v i c e product p r o d u c t standards s t a n d a r d s IEC I E C 60601-1 6 0 6 0 1 - 1 IEC I E C 61010-1 6 1 0 1 0 - 1 IEC I E C 82304-1 8 2 3 0 4 - 1 IEC I E C 725/06 7 2 5 / 0 6 Gives G i v e s specific s p e c i f i c direction d i r e c t i o n for f o r creation c r e a t i o n of o f a a safe s a f e medical m e d i c a l device d e v i c e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Gives G i v e s detailed d e t a i l e d direction d i r e c t i o n how h o w to t o develop d e v e l o p and a n d maintain m a i n t a i n safe s a f e software s o f t w a r e system s y s t e m Other O t h e r sources s o u r c e s of o f information i n f o r m a t i o n IEC/ISO I E C / I S O 12207 1 2 2 0 7 IEC I E C 61508-3 6 1 5 0 8 - 3 IEC/ISO I E C / I S O 90003, 9 0 0 0 3 , ... . . . inspires i n s p i r e s Gives G i v e s additional a d d i t i o n a l guidelines, g u i d e l i n e s , techniques, t e c h n i q u e s , etc e t c that t h a t may m a y be b e used u s e d IEC I E C Figure F i g u r e C.1 C . 1 – – Relationship R e l a t i o n s h i p of o f key k e y MEDICAL M E D I C A L DEVICE D E V I C E standards s t a n d a r d s to t o IEC I E C 62304 6 2 3 0 4 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} C.2 C . 2 Relationship R e l a t i o n s h i p to t o ISO I S O 13485 1 3 4 8 5 – – 60 6 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 This T h i s standard s t a n d a r d requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R employs e m p l o y s a a quality q u a l i t y management m a n a g e m e n t system. s y s t e m . When W h e n a a MANUFACTURER M A N U F A C T U R E R uses u s e s ISO I S O 13485 1 3 4 8 5 [8], [ 8 ] , the t h e requirements r e q u i r e m e n t s of o f ISO I S O 62304 6 2 3 0 4 directly d i r e c t l y relate r e l a t e to t o some s o m e of o f the t h e requirements r e q u i r e m e n t s of o f ISO I S O 13485 1 3 4 8 5 as a s shown s h o w n in i n Table T a b l e C.1. C . 1 . Table T a b l e C.1 C . 1 – – Relationship R e l a t i o n s h i p to t o ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 IEC I E C 62304 6 2 3 0 4 clause c l a u s e Related R e l a t e d clause c l a u s e of o f ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 7.3.1 7 . 3 . 1 Design D e s i g n and a n d development d e v e l o p m e n t planning p l a n n i n g 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.3.2 7 . 3 . 2 Design D e s i g n and a n d development d e v e l o p m e n t inputs i n p u t s 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.3.3 7 . 3 . 3 Design D e s i g n and a n d development d e v e l o p m e n t outputs o u t p u t s 7.3.4 7 . 3 . 4 Design D e s i g n and a n d development d e v e l o p m e n t review r e v i e w 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 7.3.7 7 . 3 . 7 Control C o n t r o l of o f design d e s i g n and a n d development d e v e l o p m e n t changes c h a n g e s 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d TRACEABILITY T R A C E A B I L I T Y 8.2 8 . 2 Change C h a n g e control c o n t r o l 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d TRACEABILITY T R A C E A B I L I T Y 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S C.3 C . 3 Relationship R e l a t i o n s h i p to t o ISO I S O 14971 1 4 9 7 1 Table T a b l e C.2 C . 2 shows s h o w s the t h e areas a r e a s where w h e r e IEC I E C 62304 6 2 3 0 4 amplifies a m p l i f i e s requirements r e q u i r e m e n t s for f o r the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S required r e q u i r e d by b y ISO I S O 14971. 1 4 9 7 1 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 61 6 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.2 C . 2 – – Relationship R e l a t i o n s h i p to t o ISO I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007 2 0 0 7 ISO I S O 14971:2000 1 4 9 7 1 : 2 0 0 0 2007 2 0 0 7 clause c l a u s e Related R e l a t e d clause c l a u s e of o f IEC I E C 62304 6 2 3 0 4 4.1 4 . 1 RISK R I S K ANALYSIS A N A L Y S I S procedure p r o c e d u r e process p r o c e s s 4.2 4 . 2 Intended I n t e n d e d use/intended u s e / i n t e n d e d purpose p u r p o s e and a n d identification i d e n t i f i c a t i o n of o f characteristics c h a r a c t e r i s t i c s related r e l a t e d to t o the t h e SAFETY S A F E T Y of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E 4.3 4 . 3 Identification I d e n t i f i c a t i o n of o f known k n o w n or o r foreseeable f o r e s e e a b l e HAZARDS H A Z A R D S 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S 4.4 4 . 4 Estimation E s t i m a t i o n of o f the t h e RISK(S) R I S K ( S ) for f o r each e a c h HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N 4.3 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n 5 5 RISK R I S K evaluation e v a l u a t i o n 6.1 6 . 1 RISK R I S K reduction r e d u c t i o n 6.2 6 . 2 RISK R I S K CONTROL C O N T R O L option o p t i o n analysis a n a l y s i s 7.2.1 7 . 2 . 1 Define D e f i n e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 6.3 6 . 3 Implementation I m p l e m e n t a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.2.2 7 . 2 . 2 6.4 6 . 4 RESIDUAL R E S I D U A L RISK R I S K evaluation e v a l u a t i o n 6.5 6 . 5 RISK/benefit R I S K / b e n e f i t analysis a n a l y s i s 6.6 6 . 6 Other O t h e r generated g e n e r a t e d HAZARDS H A Z A R D S RISKS R I S K S arising a r i s i n g from f r o m RISK R I S K CONTROL C O N T R O L MEASURES M E A S U R E S 7.3.1 7 . 3 . 1 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e Verify V e r i f y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.3.2 7 . 3 . 2 Document D o c u m e n t any a n y new n e w sequences s e q u e n c e s of o f events e v e n t s 6.7 6 . 7 Completeness C o m p l e t e n e s s of o f RISK R I S K evaluation e v a l u a t i o n CONTROL C O N T R O L 7 7 Evaluation E v a l u a t i o n of o f overall o v e r a l l RESIDUAL R E S I D U A L RISK R I S K evaluation e v a l u a t i o n acceptability a c c e p t a b i l i t y 8 8 RISK R I S K MANAGEMENT M A N A G E M E N T report r e p o r t 7.3.3 7 . 3 . 3 Document D o c u m e n t TRACEABILITY T R A C E A B I L I T Y 9 9 Production P r o d u c t i o n and a n d post-production p o s t - p r o d u c t i o n information i n f o r m a t i o n 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s C.4 C . 4 Relationship R e l a t i o n s h i p to t o PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 606011:2005/AMD1:2012 6 0 6 0 1 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 C.4.1 C . 4 . 1 General G e n e r a l Requirements R e q u i r e m e n t s for f o r software s o f t w a r e are a r e a a subset s u b s e t of o f the t h e requirements r e q u i r e m e n t s for f o r a a programmable p r o g r a m m a b l e electrical e l e c t r i c a l medical m e d i c a l system s y s t e m (PEMS). ( P E M S ) . This T h i s standard s t a n d a r d identifies i d e n t i f i e s requirements r e q u i r e m e n t s for f o r software s o f t w a r e which w h i c h are a r e in i n addition a d d i t i o n to, t o , but b u t not n o t incompatible i n c o m p a t i b l e with, w i t h , the t h e requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601- 6 0 6 0 1 - 1:2005 1 : 2 0 0 5 /AMD1:2012 / A M D 1 : 2 0 1 2 [1] [ 1 ] for f o r PEMS. P E M S . Because B e c a u s e PEMS P E M S include i n c l u d e elements e l e m e n t s that t h a t are a r e not n o t software, s o f t w a r e , not n o t all a l l of o f the t h e requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 for f o r PEMS P E M S are a r e addressed a d d r e s s e d in i n this t h i s standard. s t a n d a r d . With W i t h the t h e publication p u b l i c a t i o n of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601- 6 0 6 0 1 - 1:2005 1 : 2 0 0 5 /AMD1:2012, / A M D 1 : 2 0 1 2 , IEC I E C 62304 6 2 3 0 4 is i s now n o w a a normative n o r m a t i v e reference r e f e r e n c e of o f IEC I E C 60601-1 6 0 6 0 1 - 1 and a n d compliance c o m p l i a n c e with w i t h Clause C l a u s e 14 1 4 of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 (and ( a n d thus t h u s compliance c o m p l i a n c e with w i t h the t h e standard) s t a n d a r d ) requires r e q u i r e s compliance c o m p l i a n c e with w i t h parts p a r t s of o f IEC I E C 62304 6 2 3 0 4 (not ( n o t with w i t h the t h e whole w h o l e of o f IEC I E C 62304 6 2 3 0 4 because b e c a u s e IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 does d o e s not n o t require r e q u i r e compliance c o m p l i a n c e with w i t h post-production p o s t - p r o d u c t i o n and a n d maintenance m a i n t e n a n c e requirements r e q u i r e m e n t s of o f IEC I E C 62304). 6 2 3 0 4 ) . Finally, F i n a l l y , it i t is i s important i m p o r t a n t to t o remember r e m e m b e r that t h a t IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 is i s only o n l y used u s e d if i f the t h e software s o f t w a r e is i s part p a r t of o f a a PEMS P E M S and a n d not n o t if i f the t h e software s o f t w a r e is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE. D E V I C E . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . C.4.2 C . 4 . 2 Software S o f t w a r e relationship r e l a t i o n s h i p to t o PEMS P E M S development d e v e l o p m e n t By B y using u s i n g the t h e V-model V - m o d e l illustrated i l l u s t r a t e d in i n Figure F i g u r e C.2 C . 2 to t o describe d e s c r i b e what w h a t occurs o c c u r s during d u r i n g a a PEMS P E M S development, d e v e l o p m e n t , it i t can c a n be b e seen s e e n that t h a t the t h e requirements r e q u i r e m e n t s of o f this t h i s software s o f t w a r e standard s t a n d a r d apply a p p l y at a t the t h e PEMS P E M S component c o m p o n e n t level, l e v e l , from f r o m the t h e specification s p e c i f i c a t i o n of o f the t h e software s o f t w a r e requirements r e q u i r e m e n t s to t o the t h e integration i n t e g r a t i o n of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S into i n t o a a SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . This T h i s SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a part p a r t of o f a a programmable p r o g r a m m a b l e electrical e l e c t r i c a l subsystem s u b s y s t e m (PESS), ( P E S S ) , which w h i c h is i s a a part p a r t of o f a a PEMS. P E M S . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 62 6 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 User U s e r needs n e e d s Validated V a l i d a t e d PEMS P E M S PEMS P E M S requirements r e q u i r e m e n t s capture c a p t u r e PEMS P E M S validation v a l i d a t i o n plan p l a n PEMS P E M S validation v a l i d a t i o n PEMS P E M S validation v a l i d a t i o n results r e s u l t s PEMS P E M S requirement r e q u i r e m e n t specifications s p e c i f i c a t i o n s Verified V e r i f i e d PEMS P E M S PEMS P E M S architectural a r c h i t e c t u r a l design d e s i g n PEMS P E M S VERIFICATION V E R I F I C A T I O N Plan P l a n PEMS P E M S test t e s t specification s p e c i f i c a t i o n PEMS P E M S integration i n t e g r a t i o n & & VERIFICATION V E R I F I C A T I O N PEMS P E M S VERIFICATION V E R I F I C A T I O N results r e s u l t s PEMS P E M S architecture a r c h i t e c t u r e specification, s p e c i f i c a t i o n , Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) requirements r e q u i r e m e n t s specifications s p e c i f i c a t i o n s Verified V e r i f i e d Subsystem S u b s y s t e m Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) architectural a r c h i t e c t u r a l design d e s i g n Subsystem S u b s y s t e m test t e s t specification s p e c i f i c a t i o n Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) integration i n t e g r a t i o n & & VERIFICATION V E R I F I C A T I O N Subsystem S u b s y s t e m VERIFICATION V E R I F I C A T I O N results r e s u l t s Software S o f t w a r e requirements r e q u i r e m e n t s specifications s p e c i f i c a t i o n s (component ( c o m p o n e n t requirements) r e q u i r e m e n t s ) Verified V e r i f i e d software s o f t w a r e subsystem s u b s y s t e m (component) ( c o m p o n e n t ) Software S o f t w a r e integration i n t e g r a t i o n & & SOFTWARE S O F T W A R E SYSTEM S Y S T E M VERIFICATION V E R I F I C A T I O N Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n (component ( c o m p o n e n t design) d e s i g n ) (component ( c o m p o n e n t integration i n t e g r a t i o n & & verification) v e r i f i c a t i o n ) Software S o f t w a r e integration i n t e g r a t i o n and a n d VERIFICATION V E R I F I C A T I O N Software S o f t w a r e test t e s t specifications s p e c i f i c a t i o n s results r e s u l t s Portion P o r t i o n of o f PEMS P E M S V-model V - m o d e l included i n c l u d e d in i n IEC I E C 62304 6 2 3 0 4 Software S o f t w a r e ARCHITECTURE A R C H I T E C T U R E specification s p e c i f i c a t i o n Verified V e r i f i e d code c o d e Software S o f t w a r e detailed d e t a i l e d design d e s i g n (unit ( u n i t design) d e s i g n ) Software S o f t w a r e unit u n i t Software S o f t w a r e unit u n i t implementationVERIFICATION i m p l e m e n t a t i o n V E R I F I C A T I O N (unit ( u n i t VERIFICATION) V E R I F I C A T I O N ) Unit U n i t VERIFICATIO V E R I F I C A T I O results r e s u l t s N N Key: K e y : Boxes B o x e s represent r e p r e s e n t typical t y p i c a l development d e v e l o p m e n t lifecycle l i f e c y c l e activities a c t i v i t i e s Solid S o l i d Arrows A r r o w s indicate i n d i c a t e typical t y p i c a l deliverables d e l i v e r a b l e s transfered t r a n s f e r e d into/out i n t o / o u t of o f activities a c t i v i t i e s Dotted D o t t e d arrows a r r o w s indicate i n d i c a t e deliverables d e l i v e r a b l e s just j u s t to t o the t h e Risk R i s k Management M a n a g e m e n t File F i l e Outputs O u t p u t s from f r o m problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s Inputs I n p u t s to t o problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s IEC I E C 726/06 7 2 6 / 0 6 Figure F i g u r e C.2 C . 2 – – Software S o f t w a r e as a s part p a r t of o f the t h e V-model V - m o d e l C.4.3 C . 4 . 3 Development D e v e l o p m e n t PROCESS P R O C E S S Compliance C o m p l i a n c e with w i t h the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S of o f this t h i s standard s t a n d a r d (Clause ( C l a u s e 5) 5 ) requires r e q u i r e s that t h a t a a software s o f t w a r e development d e v e l o p m e n t plan p l a n be b e specified s p e c i f i e d and a n d then t h e n followed; f o l l o w e d ; it i t does d o e s not n o t require r e q u i r e that t h a t any a n y particular p a r t i c u l a r life l i f e cycle c y c l e model m o d e l is i s used, u s e d , but b u t it i t does d o e s require r e q u i r e that t h a t the t h e plan p l a n include i n c l u d e certain c e r t a i n ACTIVITIES A C T I V I T I E S and a n d have h a v e certain c e r t a i n attributes. a t t r i b u t e s . These T h e s e requirements r e q u i r e m e n t s relate r e l a t e to t o the t h e PEMS P E M S requirements r e q u i r e m e n t s in i n IEC I E C 60601-1 6 0 6 0 1 - 1 for f o r development d e v e l o p m e n t life l i f e cycle, c y c l e , requirement r e q u i r e m e n t specification, s p e c i f i c a t i o n , ARCHITECTURE, A R C H I T E C T U R E , design d e s i g n and a n d implementation, i m p l e m e n t a t i o n , and a n d VERIFICATION. V E R I F I C A T I O N . The T h e requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d provide p r o v i d e greater g r e a t e r detail d e t a i l about a b o u t software s o f t w a r e development d e v e l o p m e n t than t h a n those t h o s e in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . C.4.4 C . 4 . 4 Maintenance M a i n t e n a n c e PROCESS P R O C E S S Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Compliance C o m p l i a n c e with w i t h the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S of o f this t h i s standard s t a n d a r d (Clause ( C l a u s e 6) 6 ) requires r e q u i r e s that t h a t procedures p r o c e d u r e s be b e established e s t a b l i s h e d and a n d followed f o l l o w e d when w h e n changes c h a n g e s to t o software s o f t w a r e are a r e made. m a d e . These T h e s e require- r e q u i r e - ments m e n t s correspond c o r r e s p o n d to t o the t h e requirement r e q u i r e m e n t in i n IEC I E C 60601-1 6 0 6 0 1 - 1 for f o r modification m o d i f i c a t i o n of o f a a PEMS. P E M S . The T h e requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d for f o r software s o f t w a r e maintenance m a i n t e n a n c e provide p r o v i d e greater g r e a t e r detail d e t a i l about a b o u t what w h a t must m u s t be b e done d o n e for f o r software s o f t w a r e maintenance m a i n t e n a n c e than t h a n the t h e requirements r e q u i r e m e n t s for f o r PEMS P E M S modification m o d i f i c a t i o n in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . C.4.5 C . 4 . 5 Other O t h e r PROCESSES P R O C E S S E S The T h e other o t h e r PROCESSES P R O C E S S E S in i n this t h i s standard s t a n d a r d specify s p e c i f y additional a d d i t i o n a l requirements r e q u i r e m e n t s for f o r software s o f t w a r e beyond b e y o n d the t h e similar s i m i l a r requirements r e q u i r e m e n t s for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . In I n most m o s t cases, c a s e s , there t h e r e is i s a a general g e n e r a l requirement r e q u i r e m e n t for f o r PEMS P E M S in i n IEC I E C 60601-1, 6 0 6 0 1 - 1 , which w h i c h the t h e PROCESSES P R O C E S S E S in i n this t h i s standard s t a n d a r d expand e x p a n d upon. u p o n . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d corresponds c o r r e s p o n d s to t o the t h e additional a d d i t i o n a l RISK R I S K MANAGEMENT M A N A G E M E N T requirements r e q u i r e m e n t s identified i d e n t i f i e d for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 63 6 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d corresponds c o r r e s p o n d s to t o the t h e problem p r o b l e m resolution r e s o l u t i o n requirement r e q u i r e m e n t for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d specifies s p e c i f i e s additional a d d i t i o n a l requirements r e q u i r e m e n t s that t h a t are a r e not n o t present p r e s e n t for f o r PEMS P E M S in i n IEC I E C 60601-1 6 0 6 0 1 - 1 except e x c e p t for f o r documentation. d o c u m e n t a t i o n . C.4.6 C . 4 . 6 Coverage C o v e r a g e of o f PEMS P E M S requirements r e q u i r e m e n t s in i n IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 606011:2005 6 0 6 0 1 1 : 2 0 0 5 /AMD1:2012 / A M D 1 : 2 0 1 2 Table T a b l e C.3 C . 3 shows s h o w s the t h e PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1 6 0 6 0 1 - 1 and a n d the t h e corresponding c o r r e s p o n d i n g requirements r e q u i r e m e n t s in i n this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 64 6 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.3 C . 3 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-1 6 0 6 0 1 - 1 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.1 1 4 . 1 General G e n e r a l The T h e requirements r e q u i r e m e n t s of o f this t h i s clause c l a u s e in i n 14.2 1 4 . 2 to t o 14.12 1 4 . 1 2 (inclusive) ( i n c l u s i v e ) shall s h a l l apply a p p l y to t o PEMS P E M S unless: u n l e s s : – – the t h e PESS P E S S none n o n e of o f the t h e PROGRAMMABLE P R O G R A M M A B L E ELECTRONIC E L E C T R O N I C SUBSYSTEMS S U B S Y S T E M S (PESS) ( P E S S ) provides p r o v i d e s functionality f u n c t i o n a l i t y necessary n e c e s s a r y for f o r no n o BASIC B A S I C SAFETY S A F E T Y or o r ESSENTIAL E S S E N T I A L PERFORMANCE; P E R F O R M A N C E ; or o r – – the t h e application a p p l i c a t i o n of o f ISO I S O 14971 1 4 9 7 1 the t h e application a p p l i c a t i o n of o f RISK R I S K MANAGEMENT M A N A G E M E N T as a s described d e s c r i b e d in i n 4.2 4 . 2 demonstrates d e m o n s t r a t e s that t h a t the t h e failure f a i l u r e of o f the t h e PESS P E S S does d o e s not n o t lead l e a d to t o an a n unacceptable u n a c c e p t a b l e RISK. R I S K . The T h e requirements r e q u i r e m e n t s in i n 14.13 1 4 . 1 3 are a r e applicable a p p l i c a b l e to t o any a n y PEMS P E M S intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K whether w h e t h e r or o r not n o t the t h e requirements r e q u i r e m e n t s in i n 14.2 1 4 . 2 to t o 14.12 1 4 . 1 2 apply. a p p l y . When W h e n the t h e requirements r e q u i r e m e n t s in i n 14.2 1 4 . 2 to t o 14.13 1 4 . 1 3 apply, a p p l y , the t h e requirements r e q u i r e m e n t s in i n subclause s u b c l a u s e 4.3, 4 . 3 , Clause C l a u s e 5, 5 , Clause C l a u s e 7, 7 , Clause C l a u s e 8 8 and a n d Clause C l a u s e 9 9 of o f IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 shall s h a l l also a l s o apply a p p l y to t o the t h e development d e v e l o p m e n t or o r modification m o d i f i c a t i o n of o f software s o f t w a r e for f o r each e a c h PESS. P E S S . 14.2 1 4 . 2 Documentation D o c u m e n t a t i o n In I n addition a d d i t i o n to t o the t h e records r e c o r d s and a n d documents d o c u m e n t s required r e q u i r e d by b y ISO I S O 14971, 1 4 9 7 1 , the t h e documents d o c u m e n t s produced p r o d u c e d from f r o m application a p p l i c a t i o n of o f Clause C l a u s e 14 1 4 shall s h a l l be b e maintained m a i n t a i n e d and a n d shall s h a l l form f o r m part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . The T h e documents d o c u m e n t s required r e q u i r e d by b y Clause C l a u s e 14 1 4 shall s h a l l be b e reviewed, r e v i e w e d , approved, a p p r o v e d , issued i s s u e d and a n d changed c h a n g e d in i n accordance a c c o r d a n c e with w i t h a a formal f o r m a l document d o c u m e n t control c o n t r o l procedure. p r o c e d u r e . 14.3 1 4 . 3 RISK R I S K MANAGEMENT M A N A G E M E N T PLAN P L A N The T h e RISK R I S K MANAGEMENT M A N A G E M E N T plan p l a n required r e q u i r e d by b y 3.5 3 . 5 of o f ISO I S O 14971 1 4 9 7 1 4.2.2 4 . 2 . 2 shall s h a l l also a l s o include i n c l u d e a a reference r e f e r e n c e to t o the t h e PEMS P E M S VALIDATION V A L I D A T I O N plan p l a n (see ( s e e 14.11). 1 4 . 1 1 ) . 14.4 1 4 . 4 PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E A A PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l be b e documented. d o c u m e n t e d . The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l contain c o n t a i n a a set s e t of o f defined d e f i n e d milestones. m i l e s t o n e s . At A t each e a c h milestone, m i l e s t o n e , the t h e ACTIVITIES A C T I V I T I E S to t o be b e completed c o m p l e t e d and a n d the t h e VERIFICATION V E R I F I C A T I O N methods m e t h o d s to t o be b e applied a p p l i e d to t o those t h o s e activities a c t i v i t i e s shall s h a l l be b e defined. d e f i n e d . Each E a c h activity a c t i v i t y shall s h a l l be b e defined d e f i n e d including i n c l u d i n g its i t s inputs i n p u t s and a n d outputs. o u t p u t s . 4.3 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1 6 0 6 0 1 - 1 would w o u l d only o n l y apply a p p l y to t o software s o f t w a r e safety s a f e t y classes c l a s s e s B B and a n d C. C . This T h i s standard s t a n d a r d includes i n c l u d e s some s o m e requirements r e q u i r e m e n t s for f o r software s o f t w a r e safety s a f e t y class c l a s s A. A . The T h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S required r e q u i r e d for f o r compliance c o m p l i a n c e with w i t h IEC I E C 60601-1 6 0 6 0 1 - 1 does d o e s not n o t include i n c l u d e the t h e post p o s t production p r o d u c t i o n monitoring m o n i t o r i n g and a n d maintenance m a i n t e n a n c e required r e q u i r e d by b y Clause C l a u s e 6 6 of o f IEC I E C 62304:2006. 6 2 3 0 4 : 2 0 0 6 . 4.2 4 . 2 RISK R I S K MANAGEMENT M A N A G E M E N T 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g In I n addition a d d i t i o n to t o the t h e specific s p e c i f i c requirements r e q u i r e m e n t s in i n the t h e software s o f t w a r e development d e v e l o p m e n t planning p l a n n i n g ACTIVITY, A C T I V I T Y , documents d o c u m e n t s that t h a t are a r e part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E are a r e required r e q u i r e d to t o be b e maintained m a i n t a i n e d by b y ISO I S O 14971. 1 4 9 7 1 . In I n addition, a d d i t i o n , for f o r documents d o c u m e n t s that t h a t are a r e required r e q u i r e d by b y the t h e quality q u a l i t y system, s y s t e m , ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] requires r e q u i r e s control c o n t r o l of o f the t h e documents. d o c u m e n t s . Not N o t specifically s p e c i f i c a l l y required. r e q u i r e d . There T h e r e is i s no n o specific s p e c i f i c software s o f t w a r e validation v a l i d a t i o n plan. p l a n . The T h e PEMS P E M S validation v a l i d a t i o n plan p l a n is i s at a t the t h e SYSTEM S Y S T E M level l e v e l and a n d thus t h u s is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s software s o f t w a r e standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s require r e q u i r e TRACEABILITY T R A C E A B I L I T Y from f r o m HAZARD H A Z A R D to t o specific s p e c i f i c software s o f t w a r e cause c a u s e to t o RISK R I S K CONTROL C O N T R O L measure m e a s u r e to t o VERIFICATION V E R I F I C A T I O N of o f the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e (see ( s e e 7.3) 7 . 3 ) 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n The T h e items i t e m s addressed a d d r e s s e d by b y the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n constitute c o n s t i t u t e a a SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE. C Y C L E . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g VERIFICATION V E R I F I C A T I O N TASKS, T A S K S , milestones m i l e s t o n e s and a n d acceptance a c c e p t a n c e criteria c r i t e r i a must m u s t be b e planned. p l a n n e d . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n ACTIVITIES A C T I V I T I E S are a r e defined d e f i n e d in i n this t h i s standard. s t a n d a r d . Documentation D o c u m e n t a t i o n to t o be b e produced p r o d u c e d is i s defined d e f i n e d in i n each e a c h ACTIVITY. A C T I V I T Y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Each E a c h milestone m i l e s t o n e shall s h a l l identify i d e n t i f y the t h e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S that t h a t must m u s t be b e completed c o m p l e t e d before b e f o r e that t h a t milestone. m i l e s t o n e . The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l be b e tailored t a i l o r e d for f o r a a specific s p e c i f i c development d e v e l o p m e n t by b y making m a k i n g plans p l a n s which w h i c h detail d e t a i l ACTIVITIES, A C T I V I T I E S , milestones m i l e s t o n e s and a n d schedules. s c h e d u l e s . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n This T h i s standard s t a n d a r d allows a l l o w s the t h e development d e v e l o p m e n t life l i f e cycle c y c l e to t o be b e documented d o c u m e n t e d in i n the t h e development d e v e l o p m e n t plan. p l a n . This T h i s means m e a n s the t h e development d e v e l o p m e n t plan p l a n contains c o n t a i n s a a tailored t a i l o r e d development d e v e l o p m e n t life l i f e cycle. c y c l e . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 65 6 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l include i n c l u d e documentation d o c u m e n t a t i o n requirements. r e q u i r e m e n t s . 14.5 1 4 . 5 Problem P r o b l e m resolution r e s o l u t i o n 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S Where W h e r e appropriate, a p p r o p r i a t e , a a documented d o c u m e n t e d system s y s t e m for f o r problem p r o b l e m resolution r e s o l u t i o n within w i t h i n and a n d between b e t w e e n all a l l phases p h a s e s and a n d ACTIVITIES A C T I V I T I E S of o f the t h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE- L I F E - CYCLE C Y C L E shall s h a l l be b e developed d e v e l o p e d and a n d maintained. m a i n t a i n e d . Depending D e p e n d i n g on o n the t h e type t y p e of o f product, p r o d u c t , the t h e problem p r o b l e m resolution r e s o l u t i o n SYSTEM S Y S T E M may: m a y : � be b e documented d o c u m e n t e d as a s a a part p a r t of o f the t h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE; L I F E - C Y C L E ; � allow a l l o w the t h e reporting r e p o r t i n g of o f potential p o t e n t i a l or o r existing e x i s t i n g problems p r o b l e m s affecting a f f e c t i n g BASIC B A S I C SAFETY S A F E T Y or o r ESSENTIAL E S S E N T I A L PERFORMANCE; P E R F O R M A N C E ; � include i n c l u d e an a n assessment a s s e s s m e n t of o f each e a c h problem p r o b l e m for f o r associated a s s o c i a t e d RISKS; R I S K S ; � identify i d e n t i f y the t h e criteria c r i t e r i a that t h a t must m u s t be b e met m e t for f o r the t h e issue i s s u e to t o be b e closed; c l o s e d ; � identify i d e n t i f y the t h e action a c t i o n to t o be b e taken t a k e n to t o resolve r e s o l v e each e a c h problem. p r o b l e m . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S 14.6 1 4 . 6 RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 14.6.1 1 4 . 6 . 1 Identification I d e n t i f i c a t i o n of o f known k n o w n and a n d foreseeable f o r e s e e a b l e HAZARDS H A Z A R D S When W h e n compiling c o m p i l i n g the t h e list l i s t of o f known k n o w n or o r foreseeable f o r e s e e a b l e HAZARDS, H A Z A R D S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l consider c o n s i d e r those t h o s e HAZARDS H A Z A R D S associated a s s o c i a t e d with w i t h software s o f t w a r e and a n d hardware h a r d w a r e aspects a s p e c t s of o f the t h e PEMS P E M S including i n c l u d i n g those t h o s e associated a s s o c i a t e d with w i t h NETWORK/DATA N E T W O R K / D A T A COUPLING C O U P L I N G the t h e incorporation i n c o r p o r a t i o n of o f the t h e PEMS P E M S into i n t o an a n IT-NETWORK, I T - N E T W O R K , components c o m p o n e n t s of o f third-party t h i r d - p a r t y origin o r i g i n and a n d legacy l e g a c y subsystems. s u b s y s t e m s . 14.6.2 1 4 . 6 . 2 RISK R I S K CONTROL C O N T R O L Suitably S u i t a b l y validated v a l i d a t e d tools t o o l s and a n d PROCEDURES P R O C E D U R E S shall s h a l l be b e selected s e l e c t e d and a n d identified i d e n t i f i e d to t o implement i m p l e m e n t each e a c h RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . These T h e s e tools t o o l s and a n d PROCEDURES P R O C E D U R E S shall s h a l l be b e appropriate a p p r o p r i a t e to t o assure a s s u r e that t h a t each e a c h RISK R I S K CONTROL C O N T R O L measure m e a s u r e satisfactorily s a t i s f a c t o r i l y reduces r e d u c e s the t h e identified i d e n t i f i e d RISK(S). R I S K ( S ) . 14.7 1 4 . 7 Requirements R e q u i r e m e n t s specification s p e c i f i c a t i o n For F o r the t h e PEMS P E M S and a n d each e a c h of o f its i t s subsystems s u b s y s t e m s (e.g. ( e . g . for f o r a a PESS) P E S S ) there t h e r e shall s h a l l be b e a a documented d o c u m e n t e d requirement r e q u i r e m e n t specification. s p e c i f i c a t i o n . The T h e requirement r e q u i r e m e n t specification s p e c i f i c a t i o n for f o r a a system s y s t e m or o r subsystem s u b s y s t e m shall s h a l l include i n c l u d e and a n d distinguish d i s t i n g u i s h any a n y ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E and a n d any a n y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d by b y that t h a t system s y s t e m or o r subsystem. s u b s y s t e m . 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S This T h i s standard s t a n d a r d does d o e s not n o t mention m e n t i o n network/data n e t w o r k / d a t a coupling c o u p l i n g specifically s p e c i f i c a l l y 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g This T h i s standard s t a n d a r d requires r e q u i r e s the t h e identification i d e n t i f i c a t i o n of o f specific s p e c i f i c tools t o o l s and a n d methods m e t h o d s to t o be b e used u s e d for f o r development d e v e l o p m e n t in i n general, g e n e r a l , not n o t for f o r each e a c h RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s This T h i s standard s t a n d a r d deals d e a l s only o n l y with w i t h the t h e software s o f t w a r e subsystems s u b s y s t e m s of o f a a PEMS. P E M S . 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements. r e q u i r e m e n t s . 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t the t h e requirements r e q u i r e m e n t s related r e l a t e d to t o essential e s s e n t i a l performance p e r f o r m a n c e and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s be b e distinguished d i s t i n g u i s h e d from f r o m other o t h e r requirements, r e q u i r e m e n t s , but b u t it i t does d o e s require r e q u i r e that t h a t all a l l requirements r e q u i r e m e n t s be b e uniquely u n i q u e l y identified. i d e n t i f i e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 66 6 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.8 1 4 . 8 ARCHITECTURE A R C H I T E C T U R E For F o r the t h e PEMS P E M S and a n d each e a c h of o f its i t s subsystems, s u b s y s t e m s , an a n ARCHITECTURE A R C H I T E C T U R E shall s h a l l be b e specified s p e c i f i e d that t h a t shall s h a l l satisfy s a t i s f y the t h e requirements r e q u i r e m e n t s specification. s p e c i f i c a t i o n . Where W h e r e appropriate, a p p r o p r i a t e , to t o reduce r e d u c e the t h e RISK R I S K to t o an a n acceptable a c c e p t a b l e level, l e v e l , the t h e architecture a r c h i t e c t u r e specification s p e c i f i c a t i o n shall s h a l l make m a k e use u s e of: o f : a) a ) COMPONENTS C O M P O N E N T S WITH W I T H HIGH-INTEGRITY H I G H - I N T E G R I T Y CHARACTERISTICS; C H A R A C T E R I S T I C S ; fail-safe f a i l - s a f e functions; f u n c t i o n s ; redundancy; r e d u n d a n c y ; diversity; d i v e r s i t y ; partitioning p a r t i t i o n i n g of o f functionality; f u n c t i o n a l i t y ; defensive d e f e n s i v e design, d e s i g n , e.g. e . g . limits l i m i t s on o n potentially p o t e n t i a l l y hazardous h a z a r d o u s effects e f f e c t s by b y restricting r e s t r i c t i n g the t h e available a v a i l a b l e output o u t p u t power p o w e r or o r by b y introducing i n t r o d u c i n g means m e a n s to t o limit l i m i t the t h e travel t r a v e l of o f actuators. a c t u a t o r s . 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L Partitioning P a r t i t i o n i n g is i s the t h e only o n l y technique t e c h n i q u e identified, i d e n t i f i e d , and a n d it i t is i s only o n l y identified i d e n t i f i e d because b e c a u s e there t h e r e is i s a a requirement r e q u i r e m e n t to t o state s t a t e how h o w the t h e integrity i n t e g r i t y of o f the t h e partitioning p a r t i t i o n i n g is i s assured. a s s u r e d . The T h e ARCHITECTURE A R C H I T E C T U R E specification s p e c i f i c a t i o n shall s h a l l take t a k e into i n t o consideration: c o n s i d e r a t i o n : allocation a l l o c a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o subsystems s u b s y s t e m s and a n d components c o m p o n e n t s of o f the t h e PEMS; P E M S ; failure f a i l u r e modes m o d e s of o f components c o m p o n e n t s and a n d their t h e i r effects; e f f e c t s ; common c o m m o n cause c a u s e failures; f a i l u r e s ; systemic s y s t e m i c failures; f a i l u r e s ; test t e s t interval i n t e r v a l duration d u r a t i o n and a n d diagnostic d i a g n o s t i c coverage; c o v e r a g e ; maintainability; m a i n t a i n a b i l i t y ; protection p r o t e c t i o n from f r o m reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e misuse; m i s u s e ; the t h e IT-NETWORK/ I T - N E T W O R K / DATA D A T A COUPLING C O U P L I N G specification, s p e c i f i c a t i o n , if i f applicable. a p p l i c a b l e . 14.9 1 4 . 9 Design D e s i g n and a n d implementation i m p l e m e n t a t i o n Where W h e r e appropriate, a p p r o p r i a t e , the t h e design d e s i g n shall s h a l l be b e decomposed d e c o m p o s e d into i n t o subsystems, s u b s y s t e m s , each e a c h having h a v i n g both b o t h a a design d e s i g n and a n d test t e s t specification. s p e c i f i c a t i o n . Descriptive D e s c r i p t i v e data d a t a regarding r e g a r d i n g the t h e design d e s i g n environment e n v i r o n m e n t shall s h a l l be b e included i n c l u d e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E documentation. d o c u m e n t a t i o n . 14.10 1 4 . 1 0 VERIFICATION V E R I F I C A T I O N VERIFICATION V E R I F I C A T I O N is i s required r e q u i r e d for f o r all a l l functions f u n c t i o n s that t h a t implement i m p l e m e n t BASIC B A S I C SAFETY, S A F E T Y , ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E or o r RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . This T h i s is i s not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e a a test t e s t specification s p e c i f i c a t i o n for f o r detailed d e t a i l e d design. d e s i g n . 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g VERIFICATION V E R I F I C A T I O N is i s required r e q u i r e d for f o r each e a c h ACTIVITY A C T I V I T Y Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 67 6 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S A A VERIFICATION V E R I F I C A T I O N plan p l a n shall s h a l l be b e produced p r o d u c e d to t o show s h o w how h o w these t h e s e functions f u n c t i o n s shall s h a l l be b e verified. v e r i f i e d . The T h e plan p l a n shall s h a l l include: i n c l u d e : � at a t which w h i c h milestone(s) m i l e s t o n e ( s ) VERIFICATION V E R I F I C A T I O N is i s to t o be b e performed p e r f o r m e d on o n each e a c h function; f u n c t i o n ; � the t h e selection s e l e c t i o n and a n d documentation d o c u m e n t a t i o n of o f VERIFICATION V E R I F I C A T I O N strategies, s t r a t e g i e s , ACTIVITIES, A C T I V I T I E S , techniques, t e c h n i q u e s , and a n d the t h e appropriate a p p r o p r i a t e level l e v e l of o f independence i n d e p e n d e n c e of o f the t h e personnel p e r s o n n e l performing p e r f o r m i n g the t h e VERIFICATION; V E R I F I C A T I O N ; � the t h e selection s e l e c t i o n and a n d utilization u t i l i z a t i o n of o f VERIFICATION V E R I F I C A T I O N tools; t o o l s ; � coverage c o v e r a g e criteria c r i t e r i a for f o r VERIFICATION. V E R I F I C A T I O N . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g Independence I n d e p e n d e n c e of o f personnel p e r s o n n e l is i s not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . It I t is i s considered c o n s i d e r e d covered c o v e r e d in i n ISO I S O 13485. 1 3 4 8 5 . The T h e VERIFICATION V E R I F I C A T I O N shall s h a l l be b e performed p e r f o r m e d according a c c o r d i n g to t o the t h e VERIFICATION V E R I F I C A T I O N plan. p l a n . The T h e results r e s u l t s of o f the t h e VERIFICATION V E R I F I C A T I O N activities a c t i v i t i e s shall s h a l l be b e documented. d o c u m e n t e d . VERIFICATION V E R I F I C A T I O N requirements r e q u i r e m e n t s are a r e in i n most m o s t of o f the t h e ACTIVITIES. A C T I V I T I E S . 14.11 1 4 . 1 1 PEMS P E M S VALIDATION V A L I D A T I O N A A PEMS P E M S VALIDATION V A L I D A T I O N plan p l a n shall s h a l l include i n c l u d e the t h e validation v a l i d a t i o n of o f BASIC B A S I C SAFETY S A F E T Y and a n d ESSENTIAL E S S E N T I A L PERFORMANCE, P E R F O R M A N C E , and a n d shall s h a l l require r e q u i r e checks c h e c k s for f o r unintended u n i n t e n d e d functioning f u n c t i o n i n g of o f the t h e PEMS. P E M S . Methods M e t h o d s used u s e d for f o r PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e documented d o c u m e n t e d The T h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e performed p e r f o r m e d according a c c o r d i n g to t o the t h e PEMS P E M S VALIDATION V A L I D A T I O N plan. p l a n . The T h e results r e s u l t s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N activities a c t i v i t i e s shall s h a l l be b e documented. d o c u m e n t e d . The T h e person p e r s o n having h a v i n g the t h e overall o v e r a l l responsibility r e s p o n s i b i l i t y for f o r the t h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e independent i n d e p e n d e n t of o f the t h e design d e s i g n team. t e a m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e rationale r a t i o n a l e for f o r the t h e level l e v e l of o f independence. i n d e p e n d e n c e . No N o member m e m b e r of o f a a design d e s i g n team t e a m shall s h a l l be b e responsible r e s p o n s i b l e for f o r the t h e PEMS P E M S VALIDATION V A L I D A T I O N of o f their t h e i r own o w n design. d e s i g n . All A l l professional p r o f e s s i o n a l relationships r e l a t i o n s h i p s of o f the t h e members m e m b e r s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N team t e a m with w i t h members m e m b e r s of o f the t h e design d e s i g n team t e a m shall s h a l l be b e documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . A A reference r e f e r e n c e to t o the t h e methods m e t h o d s and a n d results r e s u l t s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e included i n c l u d e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . 14.12 1 4 . 1 2 Modification M o d i f i c a t i o n If I f any a n y or o r all a l l of o f a a design d e s i g n results r e s u l t s from f r o m a a modification m o d i f i c a t i o n of o f an a n earlier e a r l i e r design d e s i g n then t h e n either e i t h e r all a l l of o f this t h i s clause c l a u s e applies a p p l i e s as a s if i f it i t were w e r e a a new n e w design d e s i g n or o r the t h e continued c o n t i n u e d validity v a l i d i t y of o f any a n y previous p r e v i o u s design d e s i g n documentation d o c u m e n t a t i o n shall s h a l l be b e assessed a s s e s s e d under u n d e r a a documented d o c u m e n t e d modification/change m o d i f i c a t i o n / c h a n g e PROCEDURE. P R O C E D U R E . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S This T h i s standard s t a n d a r d takes t a k e s the t h e approach a p p r o a c h that t h a t software s o f t w a r e maintenance m a i n t e n a n c e should s h o u l d be b e planned p l a n n e d and a n d that t h a t implementation i m p l e m e n t a t i o n of o f modifications m o d i f i c a t i o n s should s h o u l d use u s e the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S or o r an a n established e s t a b l i s h e d software s o f t w a r e maintenance m a i n t e n a n c e PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . When W h e n software s o f t w a r e is i s modified, m o d i f i e d , the t h e requirements r e q u i r e m e n t s in i n subclause s u b c l a u s e 4.3, 4 . 3 , Clause C l a u s e 5, 5 , Clause C l a u s e 7, 7 , Clause C l a u s e 8 8 and a n d Clause C l a u s e 9 9 of o f IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 shall s h a l l also a l s o apply a p p l y to t o the t h e modification. m o d i f i c a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 68 6 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.13 1 4 . 1 3 Connection C o n n e c t i o n of o f PEMS P E M S by b y NETWORK/DATA N E T W O R K / D A T A COUPLING C O U P L I N G to t o other o t h e r equipment e q u i p m e n t PEMS P E M S intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K If I f the t h e PEMS P E M S is i s intended i n t e n d e d to t o be b e connected c o n n e c t e d by b y NETWORK/DATA N E T W O R K / D A T A COUPLING C O U P L I N G to t o other o t h e r equipment e q u i p m e n t that t h a t is i s outside o u t s i d e the t h e control c o n t r o l of o f the t h e PEMS P E M S MANUFACTURER, M A N U F A C T U R E R , the t h e technical t e c h n i c a l description d e s c r i p t i o n shall: s h a l l : specify s p e c i f y the t h e characteristics c h a r a c t e r i s t i c s of o f the t h e NETWORK/DATA N E T W O R K / D A T A COUPLING C O U P L I N G necessary n e c e s s a r y for f o r the t h e PEMS P E M S to t o achieve a c h i e v e its i t s INTENDED I N T E N D E D USE; U S E ; Requirements R e q u i r e m e n t s for f o r network/data n e t w o r k / d a t a coupling c o u p l i n g incorporation i n c o r p o r a t i o n into i n t o an a n IT- I T - network n e t w o r k are a r e not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . If I f the t h e PEMS P E M S is i s intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K that t h a t is i s not n o t validated v a l i d a t e d by b y the t h e PEMS P E M S MANUFACTURER, M A N U F A C T U R E R , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l make m a k e available a v a i l a b l e instructions i n s t r u c t i o n s for f o r implementing i m p l e m e n t i n g such s u c h connection c o n n e c t i o n including i n c l u d i n g the t h e following f o l l o w i n g the t h e purpose p u r p o s e of o f the t h e PEMS’S P E M S ’ S connection c o n n e c t i o n to t o an a n IT- I T - NETWORK; N E T W O R K ; the t h e required r e q u i r e d characteristics c h a r a c t e r i s t i c s of o f the t h e IT-NETWORK I T - N E T W O R K incorporating i n c o r p o r a t i n g the t h e PEMS; P E M S ; the t h e required r e q u i r e d configuration c o n f i g u r a t i o n of o f the t h e IT-NETWORK I T - N E T W O R K incorporating i n c o r p o r a t i n g the t h e PEMS; P E M S ; the t h e technical t e c h n i c a l specifications s p e c i f i c a t i o n s of o f the t h e network n e t w o r k connection c o n n e c t i o n of o f the t h e PEMS P E M S including i n c l u d i n g security s e c u r i t y specifications; s p e c i f i c a t i o n s ; the t h e intended i n t e n d e d information i n f o r m a t i o n flow f l o w between b e t w e e n the t h e PEMS, P E M S , the t h e IT-NETWORK I T - N E T W O R K and a n d other o t h e r devices d e v i c e s on o n the t h e IT- I T - NETWORK, N E T W O R K , and a n d the t h e intended i n t e n d e d routing r o u t i n g through t h r o u g h the t h e IT- I T - NETWORK; N E T W O R K ; and a n d NOTE N O T E 1 1 This T h i s can c a n include i n c l u d e aspects a s p e c t s of o f effectiveness e f f e c t i v e n e s s and a n d data d a t a and a n d system s y s t e m security s e c u r i t y as a s related r e l a t e d to t o BASIC B A S I C SAFETY S A F E T Y and a n d ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E (see ( s e e also a l s o Clause C l a u s e H.6 H . 6 and a n d IEC I E C 80001-1:2010). 8 0 0 0 1 - 1 : 2 0 1 0 ) . b)f) b ) f ) list l i s t the t h e HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S resulting r e s u l t i n g from f r o m a a failure f a i l u r e of o f the t h e IT-NETWORK/DATA I T - N E T W O R K / D A T A COUPLING C O U P L I N G to t o provide p r o v i d e the t h e specified s p e c i f i e d characteristics c h a r a c t e r i s t i c s required r e q u i r e d to t o meet m e e t the t h e purpose p u r p o s e of o f the t h e PEMS P E M S connection c o n n e c t i o n to t o the t h e IT- I T - NETWORK. N E T W O R K . Instruct I n s t r u c t the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N that: t h a t : In I n the t h e ACCOMPANYING A C C O M P A N Y I N G DOCUMENTS, D O C U M E N T S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l instruct i n s t r u c t the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N that: t h a t : � connection c o n n e c t i o n of o f the t h e PEMS P E M S to t o a a NETWORK N E T W O R K / / DATA D A T A COUPLING C O U P L I N G an a n IT-NETWORK I T - N E T W O R K that t h a t includes i n c l u d e s other o t h e r equipment e q u i p m e n t could c o u l d result r e s u l t in i n previously p r e v i o u s l y unidentified u n i d e n t i f i e d RISKS R I S K S to t o PATIENTS, P A T I E N T S , OPERATORS O P E R A T O R S or o r third t h i r d parties; p a r t i e s ; � the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N should s h o u l d identify, i d e n t i f y , analyze, a n a l y z e , evaluate e v a l u a t e and a n d control c o n t r o l these t h e s e RISKS; R I S K S ; Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 69 6 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S NOTE N O T E 3 3 IEC I E C 80001-1:2010 8 0 0 0 1 - 1 : 2 0 1 0 provides p r o v i d e s guidance g u i d a n c e for f o r the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N to t o address a d d r e s s these t h e s e risks. r i s k s . � subsequent s u b s e q u e n t changes c h a n g e s to t o the t h e IT-NETWORK/ I T - N E T W O R K / DATA D A T A COUPLING C O U P L I N G could c o u l d introduce i n t r o d u c e new n e w RISKS R I S K S and a n d require r e q u i r e additional a d d i t i o n a l analysis; a n a l y s i s ; and a n d � changes c h a n g e s to t o the t h e IT-NETWORK/ I T - N E T W O R K / DATA D A T A COUPLING C O U P L I N G include: i n c l u d e : � changes c h a n g e s in i n the t h e IT-NETWORK/ I T - N E T W O R K / DATA D A T A COUPLING C O U P L I N G configuration; c o n f i g u r a t i o n ; � connection c o n n e c t i o n of o f additional a d d i t i o n a l items i t e m s to t o the t h e IT- I T - NETWORK/DATA N E T W O R K / D A T A COUPLING; C O U P L I N G ; � disconnecting d i s c o n n e c t i n g items i t e m s from f r o m the t h e IT- I T - NETWORK/DATA N E T W O R K / D A T A COUPLING; C O U P L I N G ; � update u p d a t e of o f equipment e q u i p m e n t connected c o n n e c t e d to t o the t h e IT- I T - NETWORK/DATA N E T W O R K / D A T A COUPLING; C O U P L I N G ; � upgrade u p g r a d e of o f equipment e q u i p m e n t connected c o n n e c t e d to t o the t h e IT-NETWORK/ I T - N E T W O R K / DATA D A T A COUPLING C O U P L I N G . . C.4.7 C . 4 . 7 Relationship R e l a t i o n s h i p to t o requirements r e q u i r e m e n t s in i n IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 will w i l l continue c o n t i n u e to t o be b e used u s e d until u n t i l the t h e transition t r a n s i t i o n period p e r i o d for f o r IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 is i s complete. c o m p l e t e . Table T a b l e C.4 C . 4 shows s h o w s the t h e requirements r e q u i r e m e n t s of o f IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 [2] [ 2 ] and a n d the t h e related r e l a t e d requirements r e q u i r e m e n t s in i n this t h i s standard. s t a n d a r d . This T h i s does d o e s not n o t indicate i n d i c a t e that t h a t the t h e related r e l a t e d requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d fully f u l l y cover c o v e r the t h e requirements r e q u i r e m e n t s in i n IEC I E C 60601-1-4. 6 0 6 0 1 - 1 - 4 . Many M a n y parts p a r t s of o f the t h e 60601-1-4 6 0 6 0 1 - 1 - 4 requirements r e q u i r e m e n t s are a r e covered c o v e r e d by b y compliance c o m p l i a n c e with w i t h ISO I S O 14971. 1 4 9 7 1 . Some S o m e requirements r e q u i r e m e n t s in i n IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 are a r e not n o t addressed a d d r e s s e d by b y IEC I E C 62304. 6 2 3 0 4 . Table T a b l e C.4 C . 4 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1-4:1996 6 0 6 0 1 - 1 - 4 : 1 9 9 6 plus p l u s Amendment A m e n d m e n t 1:1999 1 : 1 9 9 9 Related R e l a t e d requirements r e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 6.8 6 . 8 Accompanying A c c o m p a n y i n g documents d o c u m e n t s 6.8.201 6 . 8 . 2 0 1 4.2 4 . 2 and a n d 4.3 4 . 3 c) c ) 52.201 5 2 . 2 0 1 Documentation D o c u m e n t a t i o n 52.201.1 5 2 . 2 0 1 . 1 4.1 4 . 1 52.201.2 5 2 . 2 0 1 . 2 4.1 4 . 1 and a n d 4.2 4 . 2 52.201.3 5 2 . 2 0 1 . 3 4.2 4 . 2 52.202 5 2 . 2 0 2 RISK R I S K MANAGEMENT M A N A G E M E N T PLAN P L A N 52.202.1 5 2 . 2 0 2 . 1 4.2 4 . 2 52.202.2 5 2 . 2 0 2 . 2 5.1.1, 5 . 1 . 1 , 5.1.5 5 . 1 . 5 52.202.3 5 2 . 2 0 2 . 3 4.1, 4 . 1 , 5.1.2 5 . 1 . 2 52.203 5 2 . 2 0 3 Development D e v e l o p m e n t life-cycle l i f e - c y c l e 52.203.1 5 2 . 2 0 3 . 1 5.1.1 5 . 1 . 1 52.203.2 5 2 . 2 0 3 . 2 5.1.1 5 . 1 . 1 52.203.3 5 2 . 2 0 3 . 3 52.203.4 5 2 . 2 0 3 . 4 5.1.7 5 . 1 . 7 52.203.5 5 2 . 2 0 3 . 5 7 7 52.204 5 2 . 2 0 4 Risk R i s k management m a n a g e m e n t process p r o c e s s 52.204.1 5 2 . 2 0 4 . 1 4.2 4 . 2 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 70 7 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1-4:1996 6 0 6 0 1 - 1 - 4 : 1 9 9 6 plus p l u s Amendment A m e n d m e n t 1:1999 1 : 1 9 9 9 Related R e l a t e d requirements r e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 52.204.2 5 2 . 2 0 4 . 2 4.2, 4 . 2 , 7 7 52.204.3 5 2 . 2 0 4 . 3 52.204.3.1 5 2 . 2 0 4 . 3 . 1 52.204.3.1.1 5 2 . 2 0 4 . 3 . 1 . 1 4.2, 4 . 2 , 7.1 7 . 1 52.204.3.1.2 5 2 . 2 0 4 . 3 . 1 . 2 4.2, 4 . 2 , 7.1.2 7 . 1 . 2 52.204.3.1.3 5 2 . 2 0 4 . 3 . 1 . 3 4.2 4 . 2 52.204.3.1.4 5 2 . 2 0 4 . 3 . 1 . 4 4.2, 4 . 2 , 7.1.2 7 . 1 . 2 e) e ) 52.204.3.1.5 5 2 . 2 0 4 . 3 . 1 . 5 4.2, 4 . 2 , 7.1.2 7 . 1 . 2 52.204.3.1.6 5 2 . 2 0 4 . 3 . 1 . 6 4.2, 4 . 2 , 7.1 7 . 1 52.204.3.1.7 5 2 . 2 0 4 . 3 . 1 . 7 4.2 4 . 2 52.204.3.1.8 5 2 . 2 0 4 . 3 . 1 . 8 4.2 4 . 2 52.204.3.1.9 5 2 . 2 0 4 . 3 . 1 . 9 4.2 4 . 2 52.204.3.1.10 5 2 . 2 0 4 . 3 . 1 . 1 0 4.2 4 . 2 52.204.3.2 5 2 . 2 0 4 . 3 . 2 52.204.3.2.1 5 2 . 2 0 4 . 3 . 2 . 1 4.2 4 . 2 52.204.3.2.2 5 2 . 2 0 4 . 3 . 2 . 2 4.2, 4 . 2 , 4.3 4 . 3 52.204.3.2.3 5 2 . 2 0 4 . 3 . 2 . 3 52.204.3.2.4 5 2 . 2 0 4 . 3 . 2 . 4 52.204.3.2.5 5 2 . 2 0 4 . 3 . 2 . 5 4.2 4 . 2 52.204.4 5 2 . 2 0 4 . 4 52.204.4.1 5 2 . 2 0 4 . 4 . 1 4.2 4 . 2 52.204.4.2 5 2 . 2 0 4 . 4 . 2 4.2 4 . 2 52.204.4.3 5 2 . 2 0 4 . 4 . 3 4.2 4 . 2 52.204.4.4 5 2 . 2 0 4 . 4 . 4 4.2 4 . 2 52.204.4.5 5 2 . 2 0 4 . 4 . 5 52.204.4.6 5 2 . 2 0 4 . 4 . 6 4.2 4 . 2 52.205 5 2 . 2 0 5 Qualification Q u a l i f i c a t i o n of o f personnel p e r s o n n e l 4.1 4 . 1 52.206 5 2 . 2 0 6 Requirement R e q u i r e m e n t specification s p e c i f i c a t i o n 52.206.1 5 2 . 2 0 6 . 1 5.2 5 . 2 52.206.2 5 2 . 2 0 6 . 2 7.2.2 7 . 2 . 2 52.206.3 5 2 . 2 0 6 . 3 52.207 5 2 . 2 0 7 Architecture A r c h i t e c t u r e 52.207.1 5 2 . 2 0 7 . 1 5.3.1 5 . 3 . 1 52.207.2 5 2 . 2 0 7 . 2 5.3 5 . 3 52.207.3 5 2 . 2 0 7 . 3 52.207.4 5 2 . 2 0 7 . 4 52.207.5 5 2 . 2 0 7 . 5 52.208 5 2 . 2 0 8 Design D e s i g n and a n d implementation i m p l e m e n t a t i o n 52.208.1 5 2 . 2 0 8 . 1 5 5 52.208.2 5 2 . 2 0 8 . 2 52.209 5 2 . 2 0 9 Verification V e r i f i c a t i o n 52.209.1 5 2 . 2 0 9 . 1 5.7.1 5 . 7 . 1 52.209.2 5 2 . 2 0 9 . 2 5.1.5, 5 . 1 . 5 , 5.1.6 5 . 1 . 6 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 71 7 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1-4:1996 6 0 6 0 1 - 1 - 4 : 1 9 9 6 plus p l u s Amendment A m e n d m e n t 1:1999 1 : 1 9 9 9 Related R e l a t e d requirements r e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 52.209.3 5 2 . 2 0 9 . 3 5.2.6, 5 . 2 . 6 , 5.3.6, 5 . 3 . 6 , 5.4.4, 5 . 4 . 4 , 5.5.5, 5 . 5 . 5 , 5.6, 5 . 6 , 5.7 5 . 7 52.209.4 5 2 . 2 0 9 . 4 52.210 5 2 . 2 1 0 Validation V a l i d a t i o n 52.210.1 5 2 . 2 1 0 . 1 4.1 4 . 1 52.210.2 5 2 . 2 1 0 . 2 4.1 4 . 1 52.210.3 5 2 . 2 1 0 . 3 4.1 4 . 1 52.210.4 5 2 . 2 1 0 . 4 52.210.5 5 2 . 2 1 0 . 5 52.210.6 5 2 . 2 1 0 . 6 52.210.7 5 2 . 2 1 0 . 7 52.211 5 2 . 2 1 1 Modification M o d i f i c a t i o n 52.211.1 5 2 . 2 1 1 . 1 6 6 52.211.2 5 2 . 2 1 1 . 2 4.1, 4 . 1 , 6 6 52.212 5 2 . 2 1 2 Assessment A s s e s s m e n t 52.212.1 5 2 . 2 1 2 . 1 4.1 4 . 1 IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 has h a s been b e e n withdrawn. w i t h d r a w n . C.5 C . 5 Relationship R e l a t i o n s h i p to t o IEC I E C 61010-1 6 1 0 1 0 - 1 The T h e scope s c o p e of o f IEC I E C 61010-1 6 1 0 1 0 - 1 [4 [ 4 5] 5 ] covers c o v e r s electrical e l e c t r i c a l test t e s t and a n d measuring m e a s u r i n g equipment, e q u i p m e n t , electrical e l e c t r i c a l control c o n t r o l equipment e q u i p m e n t and a n d electrical e l e c t r i c a l laboratory l a b o r a t o r y equipment. e q u i p m e n t . Only O n l y part p a r t of o f the t h e laboratory l a b o r a t o r y equipment e q u i p m e n t is i s used u s e d in i n a a medical m e d i c a l environment e n v i r o n m e n t or o r as a s in i n vitro v i t r o diagnostic d i a g n o s t i c equipment e q u i p m e n t (IVD). ( I V D ) . Due D u e to t o legal l e g a l regulations r e g u l a t i o n s or o r normative n o r m a t i v e references, r e f e r e n c e s , IVD I V D equipment e q u i p m e n t is i s allocated a l l o c a t e d to t o MEDICAL M E D I C A L DEVICES D E V I C E S without, w i t h o u t , however, h o w e v e r , falling f a l l i n g within w i t h i n the t h e scope s c o p e of o f IEC I E C 60601-1 6 0 6 0 1 - 1 [1]. [ 1 ] . This T h i s is i s attributable a t t r i b u t a b l e not n o t only o n l y to t o the t h e fact f a c t that, t h a t , strictly s t r i c t l y speaking, s p e a k i n g , IVD I V D instruments i n s t r u m e n t s are a r e not n o t MEDICAL M E D I C A L DEVICES D E V I C E S which w h i c h come c o m e into i n t o direct d i r e c t contact c o n t a c t with w i t h patients, p a t i e n t s , but b u t also a l s o to t o the t h e fact f a c t that t h a t such s u c h products p r o d u c t s are a r e manufactured m a n u f a c t u r e d for f o r many m a n y different d i f f e r e n t applications a p p l i c a t i o n s in i n various v a r i o u s laboratories. l a b o r a t o r i e s . Use U s e as a s an a n IVD I V D instrument i n s t r u m e n t or o r as a s an a n accessory a c c e s s o r y for f o r an a n IVD I V D instrument i n s t r u m e n t is i s then t h e n rare. r a r e . If I f laboratory l a b o r a t o r y equipment e q u i p m e n t is i s used u s e d as a s IVD I V D equipment, e q u i p m e n t , the t h e measured m e a s u r e d results r e s u l t s obtained o b t a i n e d must m u s t be b e EVALUATED E V A L U A T E D in i n accordance a c c o r d a n c e with w i t h medical m e d i c a l criteria. c r i t e r i a . The T h e application a p p l i c a t i o n of o f ISO I S O 14971 1 4 9 7 1 is i s required r e q u i r e d for f o r RISK R I S K MANAGEMENT. M A N A G E M E N T . If I f such s u c h products p r o d u c t s also a l s o contain c o n t a i n software s o f t w a r e that t h a t can c a n lead l e a d to t o a a HAZARD H A Z A R D HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , for f o r example e x a m p l e failure f a i l u r e caused c a u s e d by b y the t h e software s o f t w a r e which w h i c h results r e s u l t s in i n an a n unwanted u n w a n t e d change c h a n g e of o f medical m e d i c a l data d a t a (measuring ( m e a s u r i n g results), r e s u l t s ) , IEC I E C 62304 6 2 3 0 4 must m u s t be b e taken t a k e n into i n t o account. a c c o u n t . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . IEC I E C 61010-1:2010 6 1 0 1 0 - 1 : 2 0 1 0 has h a s a a general g e n e r a l requirement r e q u i r e m e n t for f o r risk r i s k assessment a s s e s s m e n t in i n Clause C l a u s e 17, 1 7 , which w h i c h is i s more m o r e streamlined s t r e a m l i n e d than t h a n the t h e full f u l l risk r i s k management m a n a g e m e n t requirements r e q u i r e m e n t s of o f ISO I S O 14971. 1 4 9 7 1 . Applying A p p l y i n g IEC I E C 61010-1 6 1 0 1 0 - 1 Clause C l a u s e 17 1 7 alone a l o n e does d o e s not n o t meet m e e t the t h e required r e q u i r e d criteria c r i t e r i a for f o r risk r i s k management m a n a g e m e n t of o f IEC I E C 62304, 6 2 3 0 4 , which w h i c h is i s based b a s e d on o n full f u l l ISO I S O 14971 1 4 9 7 1 risk r i s k management m a n a g e m e n t requirements. r e q u i r e m e n t s . With W i t h this t h i s in i n mind, m i n d , it i t is i s expected e x p e c t e d by b y this t h i s standard s t a n d a r d that t h a t when w h e n an a n IVD I V D medical m e d i c a l device d e v i c e has h a s software-related s o f t w a r e - r e l a t e d risks, r i s k s , its i t s risk r i s k management m a n a g e m e n t process p r o c e s s is i s performed p e r f o r m e d following f o l l o w i n g ISO I S O 14971 1 4 9 7 1 instead i n s t e a d of o f only o n l y Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1. 6 1 0 1 0 - 1 . Compliance C o m p l i a n c e with w i t h Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1 6 1 0 1 0 - 1 will w i l l be b e achieved, a c h i e v e d , as a s detailed d e t a i l e d in i n the t h e Note N o t e to t o Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1: 6 1 0 1 0 - 1 : NOTE N O T E One O n e RISK R I S K assessment a s s e s s m e n t procedure p r o c e d u r e is i s outlined o u t l i n e d in i n Annex A n n e x J. J . Other O t h e r RISK R I S K assessment a s s e s s m e n t procedures p r o c e d u r e s are a r e contained c o n t a i n e d in i n ISO I S O 14971, 1 4 9 7 1 , SEMI S E M I S10-1296, S 1 0 - 1 2 9 6 , IEC I E C 61508, 6 1 5 0 8 , ISO I S O 14121-1, 1 4 1 2 1 - 1 , and a n d ANSI A N S I B11.TR3. B 1 1 . T R 3 . Other O t h e r established e s t a b l i s h e d procedures p r o c e d u r e s which w h i c h implement i m p l e m e n t similar s i m i l a r steps s t e p s can c a n also a l s o be b e used. u s e d . The T h e flowchart f l o w c h a r t in i n Figure F i g u r e C.3 C . 3 provides p r o v i d e s a a useful u s e f u l aid a i d to t o explain e x p l a i n the t h e principle p r i n c i p l e way w a y of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S and a n d shows s h o w s the t h e application a p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1, 6 1 0 1 0 - 1 , Clause C l a u s e 17: 1 7 : granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Intended I n t e n d e d purpose p u r p o s e and a n d use u s e defined d e f i n e d Use U s e ISO I S O 14971 1 4 9 7 1 for f o r RISK R I S K MANAGEMENT M A N A G E M E N T Does D o e s the t h e software s o f t w a r e have h a v e any a n y impact i m p a c t on o n the t h e medical m e d i c a l data? d a t a ? Yes Y e s Use U s e of o f procedures p r o c e d u r e s required r e q u i r e d to t o verify v e r i f y the t h e data? d a t a ? No N o – – 72 7 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Possible P o s s i b l e sources s o u r c e s of o f HAZARD H A Z A R D identified i d e n t i f i e d HAZARD H A Z A R D related r e l a t e d to t o the t h e handling h a n d l i n g of o f medical m e d i c a l data d a t a Identify I d e n t i f y known k n o w n and a n d reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e HAZARDS H A Z A R D S Is I s the t h e HAZARD H A Z A R D covered c o v e r e d by b y relevant r e l e v a n t safety s a f e t y standards? s t a n d a r d s ? Yes Y e s Verify V e r i f y according a c c o r d i n g to t o the t h e relevant r e l e v a n t safety s a f e t y standard s t a n d a r d No N o Yes Y e s Does D o e s the t h e device d e v i c e No N o provide p r o v i d e medical m e d i c a l relevant r e l e v a n t data d a t a No N o Select S e l e c t an a n applicable a p p l i c a b l e method m e t h o d for f o r RISK R I S K CONTROL C O N T R O L based b a s e d on o n safety s a f e t y standard s t a n d a r d Yes Y e s Additional A d d i t i o n a l requirements r e q u i r e m e n t s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t wrong w r o n g data d a t a are a r e detected d e t e c t e d prior p r i o r to t o use u s e of o f data d a t a for f o r medical m e d i c a l purposes. p u r p o s e s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Use U s e IEC I E C 62304 6 2 3 0 4 IEC I E C 727/06 7 2 7 / 0 6 Figure F i g u r e C.3 C . 3 – – Application A p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1 6 1 0 1 0 - 1 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 73 7 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 C.6 C . 6 Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207 1 2 2 0 7 This T h i s standard s t a n d a r d has h a s been b e e n derived d e r i v e d from f r o m the t h e approach a p p r o a c h and a n d concepts c o n c e p t s of o f ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9], [ 9 ] , which w h i c h defines d e f i n e s requirements r e q u i r e m e n t s for f o r software s o f t w a r e life l i f e cycle c y c l e PROCESSES P R O C E S S E S in i n general, g e n e r a l , i.e. i . e . not n o t restricted r e s t r i c t e d to t o MEDICAL M E D I C A L DEVICES. D E V I C E S . This T h i s standard s t a n d a r d differs d i f f e r s from f r o m ISO/IEC I S O / I E C 12207 1 2 2 0 7 mainly m a i n l y with w i t h respect r e s p e c t to t o the t h e following. f o l l o w i n g . It: I t : � excludes e x c l u d e s SYSTEM S Y S T E M aspects, a s p e c t s , such s u c h as a s SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d validation; v a l i d a t i o n ; � omits o m i t s some s o m e PROCESSES P R O C E S S E S seen s e e n as a s duplicating d u p l i c a t i n g ACTIVITIES A C T I V I T I E S documented d o c u m e n t e d elsewhere e l s e w h e r e for f o r MEDICAL M E D I C A L DEVICES; D E V I C E S ; � adds a d d s the t h e (SAFETY) ( S A F E T Y ) RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S and a n d the t h e software s o f t w a r e release r e l e a s e PROCESS; P R O C E S S ; � incorporates i n c o r p o r a t e s the t h e documentation d o c u m e n t a t i o n and a n d the t h e VERIFICATION V E R I F I C A T I O N supporting s u p p o r t i n g PROCESSES P R O C E S S E S into i n t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e PROCESSES; P R O C E S S E S ; � merges m e r g e s the t h e PROCESS P R O C E S S implementation i m p l e m e n t a t i o n and a n d planning p l a n n i n g ACTIVITIES A C T I V I T I E S of o f each e a c h PROCESS P R O C E S S into i n t o a a single s i n g l e ACTIVITY A C T I V I T Y in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e PROCESSES; P R O C E S S E S ; � classifies c l a s s i f i e s the t h e requirements r e q u i r e m e n t s with w i t h respect r e s p e c t to t o SAFETY S A F E T Y needs; n e e d s ; and a n d � does d o e s not n o t explicitly e x p l i c i t l y classify c l a s s i f y PROCESSES P R O C E S S E S as a s primary p r i m a r y or o r supporting, s u p p o r t i n g , nor n o r group g r o u p PROCESSES P R O C E S S E S as a s ISO/IEC I S O / I E C 12207 1 2 2 0 7 does. d o e s . Most M o s t of o f these t h e s e changes c h a n g e s were w e r e driven d r i v e n by b y the t h e desire d e s i r e to t o tailor t a i l o r the t h e standard s t a n d a r d to t o the t h e need n e e d of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E sector s e c t o r by: b y : � focusing f o c u s i n g on o n SAFETY S A F E T Y aspects a s p e c t s and a n d the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T standard s t a n d a r d ISO I S O 14971; 1 4 9 7 1 ; � selecting s e l e c t i n g the t h e appropriate a p p r o p r i a t e PROCESSES P R O C E S S E S useful u s e f u l in i n a a regulated r e g u l a t e d environment; e n v i r o n m e n t ; taking t a k i n g into i n t o account a c c o u n t that t h a t software s o f t w a r e development d e v e l o p m e n t is i s embedded e m b e d d e d in i n a a quality q u a l i t y system s y s t e m (which ( w h i c h covers c o v e r s some s o m e of o f the t h e PROCESSES P R O C E S S E S and a n d requirements r e q u i r e m e n t s of o f ISO/IEC I S O / I E C 12207); 1 2 2 0 7 ) ; and a n d lowering l o w e r i n g the t h e level l e v e l of o f abstraction a b s t r a c t i o n to t o make m a k e it i t easier e a s i e r to t o use. u s e . This T h i s standard s t a n d a r d is i s not n o t contradictory c o n t r a d i c t o r y to t o ISO/IEC I S O / I E C 12207. 1 2 2 0 7 . ISO/IEC I S O / I E C 12207 1 2 2 0 7 can c a n be b e useful u s e f u l as a s an a n aide a i d e in i n setting s e t t i n g up u p a a well w e l l structured s t r u c t u r e d SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L that t h a t includes i n c l u d e s the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . Table T a b l e C.5, C . 5 , which w h i c h was w a s prepared p r e p a r e d by b y ISO/IEC I S O / I E C JTC1/SC7, J T C 1 / S C 7 , shows s h o w s the t h e relationship r e l a t i o n s h i p between b e t w e e n IEC I E C 62304 6 2 3 0 4 and a n d ISO/IEC I S O / I E C 12207. 1 2 2 0 7 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 74 7 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.5 C . 5 – – Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ISO/IEC I S O / I E C 62304 6 2 3 0 4 processes p r o c e s s e s ISO/IEC I S O / I E C 12207 1 2 2 0 7 processes p r o c e s s e s Activity A c t i v i t y Task T a s k Activity A c t i v i t y Task T a s k 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S 5.3 5 . 3 Development D e v e l o p m e n t process p r o c e s s 6.1 6 . 1 Documentation D o c u m e n t a t i o n process p r o c e s s 6.2 6 . 2 Configuration C o n f i g u r a t i o n management m a n a g e m e n t process p r o c e s s 6.4 6 . 4 Verification V e r i f i c a t i o n process p r o c e s s 6.5 6 . 5 Validation V a l i d a t i o n process p r o c e s s 6.8 6 . 8 Problem P r o b l e m resolution r e s o l u t i o n process p r o c e s s 7.1 7 . 1 Management M a n a g e m e n t process p r o c e s s 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.3.1 5 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.3.3 5 . 3 . 3 System S y s t e m architectural a r c h i t e c t u r a l design d e s i g n 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 5.3.10 5 . 3 . 1 0 System S y s t e m integration i n t e g r a t i o n 6.1.1 6 . 1 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.2.1 6 . 2 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.2.2 6 . 2 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.5.1 6 . 5 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.1.2 7 . 1 . 2 Planning P l a n n i n g 7.1.3 7 . 1 . 3 Execution E x e c u t i o n and a n d control c o n t r o l 7.2.2 7 . 2 . 2 Establishment E s t a b l i s h m e n t of o f the t h e infrastructure i n f r a s t r u c t u r e 7.2.3 7 . 2 . 3 Maintenance M a i n t e n a n c e of o f the t h e infrastructure i n f r a s t r u c t u r e 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 5.3.1 5 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.3.1.1 5 . 3 . 1 . 1 7.1.2 7 . 1 . 2 Planning P l a n n i n g 5.3.1.3 5 . 3 . 1 . 3 5.3.1.4 5 . 3 . 1 . 4 7.1.2.1 7 . 1 . 2 . 1 5.1.2 5 . 1 . 2 Keep K e e p software s o f t w a r e development d e v e l o p m e n t 7.1.3 7 . 1 . 3 Execution E x e c u t i o n and a n d control c o n t r o l 7.1.3.3 7 . 1 . 3 . 3 plan p l a n updated u p d a t e d 5.1.3 5 . 1 . 3 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 5.3.3 5 . 3 . 3 System S y s t e m architectural a r c h i t e c t u r a l 5.3.3.1 5 . 3 . 3 . 1 reference r e f e r e n c e to t o SYSTEM S Y S T E M design d e s i g n and a n d design d e s i g n 5.3.10.1 5 . 3 . 1 0 . 1 development d e v e l o p m e n t 5.3.10 5 . 3 . 1 0 System S y s t e m integration i n t e g r a t i o n 6.5.1.4 6 . 5 . 1 . 4 6.5.1 6 . 5 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t 5.3.1 5 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.3.1.3 5 . 3 . 1 . 3 standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s 5.3.1.4 5 . 3 . 1 . 4 planning p l a n n i n g 5.1.5 5 . 1 . 5 Software S o f t w a r e integration i n t e g r a t i o n and a n d 5.3.8 5 . 3 . 8 Software S o f t w a r e integration. i n t e g r a t i o n . 5.3.8.1 5 . 3 . 8 . 1 integration i n t e g r a t i o n testing t e s t i n g planning p l a n n i n g 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.4.1.4 6 . 4 . 1 . 4 planning p l a n n i n g 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d 6.4.1.5 6 . 4 . 1 . 5 testing t e s t i n g 5.3.7.5 5 . 3 . 7 . 5 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.8.5 5 . 3 . 8 . 5 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n 5.3.9.3 5 . 3 . 9 . 3 testing t e s t i n g 5.1.7 5 . 1 . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T planning p l a n n i n g Amd.1:2002 A m d . 1 : 2 0 0 2 – – F F 3.1.5 3 . 1 . 5 Risk R i s k management m a n a g e m e n t process p r o c e s s 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g 6.1.1 6 . 1 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.1.1.1 6 . 1 . 1 . 1 5.1.9 5 . 1 . 9 Software S o f t w a r e configuration c o n f i g u r a t i o n 6.2.1 6 . 2 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.2.1.1 6 . 2 . 1 . 1 management m a n a g e m e n t planning p l a n n i n g 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 5.1.10 5 . 1 . 1 0 Supporting S u p p o r t i n g items i t e m s to t o be b e 7.2.2 7 . 2 . 2 Establishment E s t a b l i s h m e n t of o f the t h e 7.2.2.1 7 . 2 . 2 . 1 controlled c o n t r o l l e d infrastructure i n f r a s t r u c t u r e 7.2.3 7 . 2 . 3 Maintenance M a i n t e n a n c e of o f the t h e 7.2.3.1 7 . 2 . 3 . 1 infrastructure i n f r a s t r u c t u r e 5.1.11 5 . 1 . 1 1 Software S o f t w a r e CONFIGURATION C O N F I G U R A T I O N 6.2.2 6 . 2 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 6.2.2.1 6 . 2 . 2 . 1 ITEM I T E M control c o n t r o l before b e f o r e VERIFICATION V E R I F I C A T I O N 5.2 5 . 2 Software S o f t w a r e 5.3.3 5 . 3 . 3 System S y s t e m architectural a r c h i t e c t u r a l Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 75 7 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 processes p r o c e s s e s ISO/IEC I S O / I E C 12207 1 2 2 0 7 processes p r o c e s s e s Activity A c t i v i t y Task T a s k Activity A c t i v i t y Task T a s k requirements r e q u i r e m e n t s analysis a n a l y s i s design d e s i g n 5.3.4 5 . 3 . 4 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements r e q u i r e m e n t s 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s 5.2.4 5 . 2 . 4 Re-EVALUATE R e - E V A L U A T E MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S 5.2.5 5 . 2 . 5 Update U p d a t e SYSTEM S Y S T E M requirements r e q u i r e m e n t s 5.2.6 5 . 2 . 6 Verify V e r i f y software s o f t w a r e requirements r e q u i r e m e n t s 5.3.1 5 . 3 . 1 Transform T r a n s f o r m software s o f t w a r e requirements r e q u i r e m e n t s into i n t o an a n ARCHITECTURE A R C H I T E C T U R E 5.3.2 5 . 3 . 2 Develop D e v e l o p an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s of o f SOFTWARE S O F T W A R E ITEMS I T E M S 5.3.3 5 . 3 . 3 Specify S p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s of o f SOUP S O U P item i t e m 5.3.4 5 . 3 . 4 Specify S p e c i f y SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e required r e q u i r e d by b y SOUP S O U P item i t e m 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L 5.3.6 5 . 3 . 6 Verify V e r i f y software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E 5.4.1 5 . 4 . 1 Refine R e f i n e SOFTWARE S O F T W A R E ARCHITECTURE A R C H I T E C T U R E into i n t o SOFTWARE S O F T W A R E UNITS U N I T S 5.3.3 5 . 3 . 3 System S y s t e m architectural a r c h i t e c t u r a l design d e s i g n 5.3.4 5 . 3 . 4 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.3.4 5 . 3 . 4 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.3.4 5 . 3 . 4 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3.5 5 . 3 . 5 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 5.3.5 5 . 3 . 5 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 5.3.5 5 . 3 . 5 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 5.3.3.1 5 . 3 . 3 . 1 5.3.4.1 5 . 3 . 4 . 1 None N o n e b) b ) 5.3.4.2 5 . 3 . 4 . 2 6.4.2.3 6 . 4 . 2 . 3 5.3.5.1 5 . 3 . 5 . 1 5.3.5.2 5 . 3 . 5 . 2 none n o n e none n o n e none n o n e 5.3.5.6 5 . 3 . 5 . 6 5.3.6 5 . 3 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3.6 5 . 3 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.3.6.1 5 . 3 . 6 . 1 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.4.3 5 . 4 . 3 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r 5.3.6.2 5 . 3 . 6 . 2 interfaces i n t e r f a c e s 5.4.4 5 . 4 . 4 Verify V e r i f y detailed d e t a i l e d design d e s i g n 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3.6.7 5 . 3 . 6 . 7 5.3.6 5 . 3 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.5.1 5 . 5 . 1 Implement I m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.5.2 5 . 5 . 2 Establish E s t a b l i s h SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N PROCESS P R O C E S S 5.5.3 5 . 5 . 3 SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 5.5.4 5 . 5 . 4 Additional A d d i t i o n a l SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 5.5.5 5 . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 5.3.6 5 . 3 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3.7 5 . 3 . 7 Software S o f t w a r e coding c o d i n g and a n d testing t e s t i n g 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n 5.3.7.1 5 . 3 . 7 . 1 5.3.6.5 5 . 3 . 6 . 5 5.3.7.5 5 . 3 . 7 . 5 5.3.7.5 5 . 3 . 7 . 5 5.3.7.5 5 . 3 . 7 . 5 6.4.2.5 6 . 4 . 2 . 5 5.3.7.2 5 . 3 . 7 . 2 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 76 7 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g ISO/IEC I S O / I E C 62304 6 2 3 0 4 processes p r o c e s s e s ISO/IEC I S O / I E C 12207 1 2 2 0 7 processes p r o c e s s e s Activity A c t i v i t y Task T a s k Activity A c t i v i t y Task T a s k testing t e s t i n g 5.3.10 5 . 3 . 1 0 System S y s t e m integration i n t e g r a t i o n 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.6.1 5 . 6 . 1 Integrate I n t e g r a t e SOFTWARE S O F T W A R E UNITS U N I T S 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.8.2 5 . 3 . 8 . 2 5.6.2 5 . 6 . 2 Verify V e r i f y software s o f t w a r e integration i n t e g r a t i o n 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.10 5 . 3 . 1 0 System S y s t e m integration i n t e g r a t i o n 5.6.3 5 . 6 . 3 Test T e s t integrated i n t e g r a t e d software s o f t w a r e 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing. t e s t i n g . 5.3.8.2 5 . 3 . 8 . 2 5.3.10.1 5 . 3 . 1 0 . 1 5.3.9.1 5 . 3 . 9 . 1 5.6.4 5 . 6 . 4 Integration I n t e g r a t i o n testing t e s t i n g content c o n t e n t 5.3.9.3 5 . 3 . 9 . 3 5.6.5 5 . 6 . 5 Verify V e r i f y integration i n t e g r a t i o n tests t e s t s 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 6.4.2.2 6 . 4 . 2 . 2 procedures p r o c e d u r e s 5.6.6 5 . 6 . 6 Conduct C o n d u c t regression r e g r e s s i o n tests t e s t s 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.8.2 5 . 3 . 8 . 2 5.6.7 5 . 6 . 7 Integration I n t e g r a t i o n test t e s t record r e c o r d 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.8.2 5 . 3 . 8 . 2 contents c o n t e n t s 5.6.8 5 . 6 . 8 Use U s e software s o f t w a r e problem p r o b l e m 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.4.1.6 6 . 4 . 1 . 6 resolution r e s o l u t i o n PROCESS P R O C E S S 5.7.1 5 . 7 . 1 Establish E s t a b l i s h tests t e s t s for f o r each e a c h software s o f t w a r e requirement r e q u i r e m e n t 5.7.2 5 . 7 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.3.8 5 . 3 . 8 Software S o f t w a r e integration i n t e g r a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 5.3.8.4 5 . 3 . 8 . 4 5.3.9.1 5 . 3 . 9 . 1 6.4.1 6 . 4 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.4.1.6 6 . 4 . 1 . 6 5.7.3 5 . 7 . 3 Retest R e t e s t after a f t e r changes c h a n g e s 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 5.7.4 5 . 7 . 4 Verify V e r i f y SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 5.7.5 5 . 7 . 5 Document D o c u m e n t data d a t a for f o r each e a c h test t e s t SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t record r e c o r d content c o n t e n t 6.4.2 6 . 4 . 2 Verification V e r i f i c a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 5.4.2 5 . 4 . 2 Operational O p e r a t i o n a l testing t e s t i n g 6.2.5 6 . 2 . 5 Configuration C o n f i g u r a t i o n evaluation e v a l u a t i o n 6.2.6 6 . 2 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 5.8.1 5 . 8 . 1 Ensure E n s u r e software s o f t w a r e VERIFICATION V E R I F I C A T I O N is i s complete c o m p l e t e 5.8.2 5 . 8 . 2 Document D o c u m e n t known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S 5.8.3 5 . 8 . 3 Evaluate E v a l u a t e known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S 5.8.4 5 . 8 . 4 Document D o c u m e n t released r e l e a s e d VERSIONS V E R S I O N S 5.8.5 5 . 8 . 5 Document D o c u m e n t how h o w released r e l e a s e d software s o f t w a r e was w a s created c r e a t e d 5.8.6 5 . 8 . 6 Ensure E n s u r e activities a c t i v i t i e s and a n d tasks t a s k s are a r e complete c o m p l e t e 5.8.7 5 . 8 . 7 Archive A r c h i v e software s o f t w a r e 5.8.8 5 . 8 . 8 Assure A s s u r e repeatability r e p e a t a b i l i t y of o f software s o f t w a r e release r e l e a s e 5.4.2 5 . 4 . 2 Operational O p e r a t i o n a l testing t e s t i n g 6.2.6 6 . 2 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 6.2.5 6 . 2 . 5 Configuration C o n f i g u r a t i o n evaluation e v a l u a t i o n 5.3.9 5 . 3 . 9 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 6.2.6 6 . 2 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 6.4.2.2 6 . 4 . 2 . 2 5.3.9.3 5 . 3 . 9 . 3 5.3.9.1 5 . 3 . 9 . 1 5.4.2.1 5 . 4 . 2 . 1 5.4.2.2 5 . 4 . 2 . 2 6.2.6.1 6 . 2 . 6 . 1 6.2.5.1 6 . 2 . 5 . 1 5.3.9.3 5 . 3 . 9 . 3 6.2.6.1 6 . 2 . 6 . 1 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S 5.5 5 . 5 Maintenance M a i n t e n a n c e process p r o c e s s 6.2 6 . 2 Configuration C o n f i g u r a t i o n management m a n a g e m e n t process p r o c e s s 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e 5.5.1 5 . 5 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 5.5.1.1 5 . 5 . 1 . 1 maintenance m a i n t e n a n c e plan p l a n 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 5.5.1 5 . 5 . 1 Process P r o c e s s Implementation I m p l e m e n t a t i o n 5.5.2 5 . 5 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 77 7 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n ISO/IEC I S O / I E C 62304 6 2 3 0 4 processes p r o c e s s e s ISO/IEC I S O / I E C 12207 1 2 2 0 7 processes p r o c e s s e s Activity A c t i v i t y Task T a s k Activity A c t i v i t y Task T a s k analysis a n a l y s i s 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 5.5.5 5 . 5 . 5 Migration M i g r a t i o n 6.2.1 6 . 2 . 1 Record R e c o r d and a n d evaluate e v a l u a t e feedback f e e d b a c k 6.2.1.1 6 . 2 . 1 . 1 Monitor M o n i t o r feedback f e e d b a c k 5.5.1 5 . 5 . 1 Process P r o c e s s Implementation I m p l e m e n t a t i o n 5.5.1.1 5 . 5 . 1 . 1 6.2.1.2 6 . 2 . 1 . 2 Document D o c u m e n t and a n d EVALUATE E V A L U A T E 5.5.1.2 5 . 5 . 1 . 2 feedback f e e d b a c k 6.2.1.3 6 . 2 . 1 . 3 Evaluate E v a l u a t e PROBLEM P R O B L E M REPORT’S R E P O R T ’ S affects a f f e c t s on o n SAFETY S A F E T Y 6.2.2 6 . 2 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 5.5.2 5 . 5 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 5.5.2.1 5 . 5 . 2 . 1 5.5.2.2 5 . 5 . 2 . 2 5.5.2.3 5 . 5 . 2 . 3 5.5.2.4 5 . 5 . 2 . 4 5.5.1 5 . 5 . 1 Process P r o c e s s Implementation I m p l e m e n t a t i o n 5.5.1.2 5 . 5 . 1 . 2 6.2.3 6 . 2 . 3 Analyse A n a l y s e CHANGE C H A N G E REQUESTS R E Q U E S T S 5.5.2 5 . 5 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.2.4 6 . 2 . 4 CHANGE C H A N G E REQUEST R E Q U E S T approval a p p r o v a l 5.5.2 5 . 5 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.2.5 6 . 2 . 5 Communicate C o m m u n i c a t e to t o users u s e r s and a n d regulators r e g u l a t o r s 6.3.1 6 . 3 . 1 Use U s e established e s t a b l i s h e d PROCESS P R O C E S S to t o implement i m p l e m e n t modification m o d i f i c a t i o n 6.3.2 6 . 3 . 2 Re-release R e - r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEM S Y S T E M 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 5.5.5 5 . 5 . 5 Migration M i g r a t i o n 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.2.6 6 . 2 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.2.6 6 . 2 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 5.5.2.1 5 . 5 . 2 . 1 5.5.2.5 5 . 5 . 2 . 5 5.5.3.1 5 . 5 . 3 . 1 5.5.5.3 5 . 5 . 5 . 3 5.5.3.2 5 . 5 . 3 . 2 6.2.6.1 6 . 2 . 6 . 1 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S Amd.1:2002 A m d . 1 : 2 0 0 2 – – F F 3.15 3 . 1 5 Risk R i s k management m a n a g e m e n t process p r o c e s s Process P r o c e s s in i n 62304 6 2 3 0 4 addresses a d d r e s s e s risk r i s k / / hazard h a z a r d issues i s s u e s that t h a t are a r e not n o t addressed a d d r e s s e d in i n Amd A m d 1. 1 . There T h e r e is i s some s o m e commonality c o m m o n a l i t y (risk ( r i s k measures, m e a s u r e s , etc) e t c ) but b u t the t h e focus f o c u s of o f the t h e analysis a n a l y s i s is i s quite q u i t e different. d i f f e r e n t . 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S 5.5 5 . 5 Maintenance M a i n t e n a n c e process p r o c e s s 6.2 6 . 2 Configuration C o n f i g u r a t i o n management m a n a g e m e n t process p r o c e s s 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 8.1.1 8 . 1 . 1 Establish E s t a b l i s h means m e a n s to t o identify i d e n t i f y CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S 6.2.2 6 . 2 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 6.2.2 6 . 2 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 6.2.2.1 6 . 2 . 2 . 1 8.1.2 8 . 1 . 2 Identify I d e n t i f y SOUP S O U P none n o n e 8.1.3 8 . 1 . 3 Identify I d e n t i f y SYSTEM S Y S T E M 6.2.2 6 . 2 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 6.2.2.1 6 . 2 . 2 . 1 configuration c o n f i g u r a t i o n documentation d o c u m e n t a t i o n 8.2 8 . 2 Change C h a n g e control c o n t r o l 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.2.3 6 . 2 . 3 Configuration C o n f i g u r a t i o n control c o n t r o l 8.2.1 8 . 2 . 1 Approve A p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S 6.2.3 6 . 2 . 3 Configuration C o n f i g u r a t i o n control c o n t r o l 6.2.3.1 6 . 2 . 3 . 1 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g 8.2.2 8 . 2 . 2 Implement I m p l e m e n t changes c h a n g e s 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.2.3 6 . 2 . 3 Configuration C o n f i g u r a t i o n control c o n t r o l 5.5.3.2 5 . 5 . 3 . 2 6.2.3.1 6 . 2 . 3 . 1 8.2.3 8 . 2 . 3 Verify V e r i f y changes c h a n g e s 6.2.3 6 . 2 . 3 Configuration C o n f i g u r a t i o n control c o n t r o l 6.2.3.1 6 . 2 . 3 . 1 8.2.4 8 . 2 . 4 Provide P r o v i d e means m e a n s for f o r TRACEABILITY T R A C E A B I L I T Y of o f change c h a n g e 6.2.4 6 . 2 . 4 Configuration C o n f i g u r a t i o n status s t a t u s 6.2.4.1 6 . 2 . 4 . 1 accounting a c c o u n t i n g 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 5.5 5 . 5 Maintenance M a i n t e n a n c e process p r o c e s s 6.2 6 . 2 Configuration C o n f i g u r a t i o n management m a n a g e m e n t 6.8 6 . 8 Problem P r o b l e m resolution r e s o l u t i o n process p r o c e s s 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem p r o b l e m 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties p a r t i e s 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.2 6 . 8 . 2 Problem P r o b l e m resolution r e s o l u t i o n 6.8.2 6 . 8 . 2 Problem P r o b l e m resolution r e s o l u t i o n 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 b) b ) 6.8.2.1 6 . 8 . 2 . 1 6.8.2.1 6 . 8 . 2 . 1 6.8.1.1 6 . 8 . 1 . 1 b) b ) 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 a) a ) Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 78 7 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 processes p r o c e s s e s ISO/IEC I S O / I E C 12207 1 2 2 0 7 processes p r o c e s s e s Activity A c t i v i t y Task T a s k Activity A c t i v i t y Task T a s k 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process p r o c e s s 6.2.3 6 . 2 . 3 Configuration C o n f i g u r a t i o n control. c o n t r o l . 5.5.3 5 . 5 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 9.5 9 . 5 Maintain M a i n t a i n records r e c o r d s 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 a) a ) 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends t r e n d s 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.2 6 . 8 . 2 Problem P r o b l e m resolution r e s o l u t i o n 6.8.1.1 6 . 8 . 1 . 1 b) b ) 6.8.2.1 6 . 8 . 2 . 1 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n 6.8.1 6 . 8 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 6.8.1.1 6 . 8 . 1 . 1 d) d ) 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents c o n t e n t s All A l l testing t e s t i n g tasks t a s k s in i n 12207 1 2 2 0 7 require r e q u i r e documentation d o c u m e n t a t i o n ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 7.1.1 7 . 1 . 1 Software S o f t w a r e Implementation I m p l e m e n t a t i o n 7.1.1.3.1 7 . 1 . 1 . 3 . 1 Software S o f t w a r e implementation i m p l e m e n t a t i o n strategy s t r a t e g y 7.1.1.3.1.1 7 . 1 . 1 . 3 . 1 . 1 7.1.1.3.1.3 7 . 1 . 1 . 3 . 1 . 3 7.1.1.3.1.4 7 . 1 . 1 . 3 . 1 . 4 6.3.1.3.2 6 . 3 . 1 . 3 . 2 Project P r o j e c t planning p l a n n i n g 6.3.1.3.2.1 6 . 3 . 1 . 3 . 2 . 1 5.1.2 5 . 1 . 2 Keep K e e p software s o f t w a r e development d e v e l o p m e n t plan p l a n updated u p d a t e d 6.3.2 6 . 3 . 2 Project P r o j e c t Assesment A s s e s m e n t and a n d Control C o n t r o l 6.3.2.3.2 6 . 3 . 2 . 3 . 2 Project P r o j e c t control c o n t r o l 6.3.2.3.2.1 6 . 3 . 2 . 3 . 2 . 1 5.1.3 5 . 1 . 3 Software S o f t w a r e development d e v e l o p m e n t plan p l a n reference r e f e r e n c e to t o SYSTEM S Y S T E M design d e s i g n and a n d development d e v e l o p m e n t 6.4.3 6 . 4 . 3 System S y s t e m Architectural A r c h i t e c t u r a l Design D e s i g n 6.4.5 6 . 4 . 5 System S y s t e m Integration I n t e g r a t i o n 7.2.5 7 . 2 . 5 Software S o f t w a r e Validation V a l i d a t i o n Process P r o c e s s 6.4.3.3.1 6 . 4 . 3 . 3 . 1 Establishing E s t a b l i s h i n g architecture a r c h i t e c t u r e 6.4.3.3.1.1 6 . 4 . 3 . 3 . 1 . 1 6.4.5.3.1 6 . 4 . 5 . 3 . 1 Integration I n t e g r a t i o n 6.4.5.3.1.1 6 . 4 . 5 . 3 . 1 . 1 7.2.5.3.1 7 . 2 . 5 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.5.3.1.4 7 . 2 . 5 . 3 . 1 . 4 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g 7.1.1 7 . 1 . 1 Software S o f t w a r e Implementation I m p l e m e n t a t i o n 7.1.1.3.1 7 . 1 . 1 . 3 . 1 Software S o f t w a r e implementation i m p l e m e n t a t i o n strategy s t r a t e g y 7.1.1.3.1.3 7 . 1 . 1 . 3 . 1 . 3 5.1.5 5 . 1 . 5 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g planning p l a n n i n g 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.1 7 . 1 . 6 . 3 . 1 . 1 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.4 7 . 2 . 4 . 3 . 1 . 4 7.2.4.3.1.5 7 . 2 . 4 . 3 . 1 . 5 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e constrution c o n s t r u t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.5 7 . 1 . 6 . 3 . 1 . 5 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.1.7 5 . 1 . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T planning p l a n n i n g 6.3.4 6 . 3 . 4 Risk R i s k Management M a n a g e m e n t Process P r o c e s s 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g 7.2.1 7 . 2 . 1 Software S o f t w a r e Documentation D o c u m e n t a t i o n Management M a n a g e m e n t 7.2.1.3.1 7 . 2 . 1 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.1.3.1.1 7 . 2 . 1 . 3 . 1 . 1 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 79 7 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.1.9 5 . 1 . 9 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t planning p l a n n i n g 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.2.3.1 7 . 2 . 2 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.2.3.1.1 7 . 2 . 2 . 3 . 1 . 1 7.2.8.3.1 7 . 2 . 8 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.8.3.1.1 7 . 2 . 8 . 3 . 1 . 1 5.1.10 5 . 1 . 1 0 Supporting S u p p o r t i n g items i t e m s to t o be b e controlled c o n t r o l l e d 6.2.2 6 . 2 . 2 Infrastructure I n f r a s t r u c t u r e Management M a n a g e m e n t 6.2.2 6 . 2 . 2 Infrastructure I n f r a s t r u c t u r e Management M a n a g e m e n t 6.2.2.3.2 6 . 2 . 2 . 3 . 2 Establishment E s t a b l i s h m e n t of o f the t h e infrastructure i n f r a s t r u c t u r e 6.2.2.3.2.1 6 . 2 . 2 . 3 . 2 . 1 6.2.2.3.3 6 . 2 . 2 . 3 . 3 Maintenance M a i n t e n a n c e of o f the t h e infrastructure i n f r a s t r u c t u r e 6.2.2.3.3.1 6 . 2 . 2 . 3 . 3 . 1 5.1.11 5 . 1 . 1 1 Software S o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEM I T E M control c o n t r o l before b e f o r e VERIFICATION V E R I F I C A T I O N 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.2.3.2 7 . 2 . 2 . 3 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.2.2.3.2.1 7 . 2 . 2 . 3 . 2 . 1 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements r e q u i r e m e n t s 6.4.3 6 . 4 . 3 System S y s t e m Architectural A r c h i t e c t u r a l Design D e s i g n 6.4.3.3.1 6 . 4 . 3 . 3 . 1 Establishing E s t a b l i s h i n g architecture a r c h i t e c t u r e 6.4.3.3.1.1 6 . 4 . 3 . 3 . 1 . 1 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t 7.1.2 7 . 1 . 2 Software S o f t w a r e Requirements R e q u i r e m e n t s Analysis A n a l y s i s 7.1.2.3.1 7 . 1 . 2 . 3 . 1 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.1.2.3.1.1 7 . 1 . 2 . 3 . 1 . 1 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s 5.2.4 5 . 2 . 4 Re-EVALUATE R e - E V A L U A T E MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S None N o n e None N o n e 5.2.5 5 . 2 . 5 Update U p d a t e SYSTEM S Y S T E M requirements r e q u i r e m e n t s 7.1.2 7 . 1 . 2 Software S o f t w a r e Requirements R e q u i r e m e n t s Analysis A n a l y s i s 7.1.2.3.1 7 . 1 . 2 . 3 . 1 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.1.2.3.1.1 7 . 1 . 2 . 3 . 1 . 1 a) a ) & & b) b ) 5.2.6 5 . 2 . 6 Verify V e r i f y software s o f t w a r e requirements r e q u i r e m e n t s 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.2 7 . 2 . 4 . 3 . 2 Verification V e r i f i c a t i o n 7.2.4.3.2.1 7 . 2 . 4 . 3 . 2 . 1 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.1 5 . 3 . 1 Transform T r a n s f o r m software s o f t w a r e requirements r e q u i r e m e n t s into i n t o an a n ARCHITECTURE A R C H I T E C T U R E 7.1.3 7 . 1 . 3 Software S o f t w a r e Architectural A r c h i t e c t u r a l Design D e s i g n 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.1 7 . 1 . 3 . 3 . 1 . 1 5.3.2 5 . 3 . 2 Develop D e v e l o p an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s of o f SOFTWARE S O F T W A R E ITEMS I T E M S 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.2 7 . 1 . 3 . 3 . 1 . 2 5.3.3 5 . 3 . 3 Specify S p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s of o f SOUP S O U P item i t e m None N o n e none n o n e 5.3.4 5 . 3 . 4 Specify S p e c i f y SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e required r e q u i r e d by b y SOUP S O U P item i t e m None N o n e none n o n e 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L None N o n e none n o n e 5.3.6 5 . 3 . 6 Verify V e r i f y software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E 7.1.3 7 . 1 . 3 Software S o f t w a r e Architectural A r c h i t e c t u r a l Design D e s i g n 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.6 7 . 1 . 3 . 3 . 1 . 6 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.1 5 . 4 . 1 Refine R e f i n e SOFTWARE S O F T W A R E ARCHITECTURE A R C H I T E C T U R E into i n t o SOFTWARE S O F T W A R E UNITS U N I T S 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.1 7 . 1 . 4 . 3 . 1 . 1 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.4.3 5 . 4 . 3 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r interfaces i n t e r f a c e s 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.2 7 . 1 . 4 . 3 . 1 . 2 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 80 8 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.4.4 5 . 4 . 4 Verify V e r i f y detailed d e t a i l e d design d e s i g n 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.7 7 . 1 . 4 . 3 . 1 . 7 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.5.1 5 . 5 . 1 Implement I m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.1 7 . 1 . 5 . 3 . 1 . 1 5.5.2 5 . 5 . 2 Establish E s t a b l i s h SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N PROCESS P R O C E S S 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.5 7 . 1 . 4 . 3 . 1 . 5 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 5.5.3 5 . 5 . 3 SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 5.5.4 5 . 5 . 4 Additional A d d i t i o n a l SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.2 7 . 1 . 5 . 3 . 1 . 2 5.5.5 5 . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.2 7 . 1 . 5 . 3 . 1 . 2 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.6.1 5 . 6 . 1 Integrate I n t e g r a t e SOFTWARE S O F T W A R E UNITS U N I T S 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.2 5 . 6 . 2 Verify V e r i f y software s o f t w a r e integration i n t e g r a t i o n 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 6.4.5 6 . 4 . 5 System S y s t e m Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 6.4.5.3.1 6 . 4 . 5 . 3 . 1 Integration I n t e g r a t i o n 6.4.5.3.1.2 6 . 4 . 5 . 3 . 1 . 2 5.6.3 5 . 6 . 3 Test T e s t integrated i n t e g r a t e d software s o f t w a r e 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.6.4 5 . 6 . 4 Integration I n t e g r a t i o n testing t e s t i n g content c o n t e n t 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.6.5 5 . 6 . 5 Verify V e r i f y integration i n t e g r a t i o n tests t e s t s procedures p r o c e d u r e s None N o n e None N o n e 5.6.6 5 . 6 . 6 Conduct C o n d u c t regression r e g r e s s i o n tests t e s t s 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.7 5 . 6 . 7 Integration I n t e g r a t i o n test t e s t record r e c o r d contents c o n t e n t s 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.8 5 . 6 . 8 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.6 7 . 2 . 4 . 3 . 1 . 6 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 5.7.1 5 . 7 . 1 Establish E s t a b l i s h tests t e s t s for f o r each e a c h software s o f t w a r e requirement r e q u i r e m e n t 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.4 7 . 1 . 6 . 3 . 1 . 4 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.7.2 5 . 7 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.6 7 . 2 . 4 . 3 . 1 . 6 5.7.3 5 . 7 . 3 Retest R e t e s t after a f t e r changes c h a n g e s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8.3.1 7 . 2 . 8 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.8.3.1.1 7 . 2 . 8 . 3 . 1 . 1 5.7.4 5 . 7 . 4 Verify V e r i f y SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 81 8 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.7.5 5 . 7 . 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t record r e c o r d contents c o n t e n t s 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 5.8.1 5 . 8 . 1 Ensure E n s u r e software s o f t w a r e VERIFICATION V E R I F I C A T I O N is i s complete c o m p l e t e 6.4.9 6 . 4 . 9 Software S o f t w a r e Operation O p e r a t i o n 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 6.4.9.3.2 6 . 4 . 9 . 3 . 2 Operation O p e r a t i o n activation a c t i v a t i o n and a n d check-out c h e c k - o u t 6.4.9.3.2.1 6 . 4 . 9 . 3 . 2 . 1 6.4.9.3.2.2 6 . 4 . 9 . 3 . 2 . 2 7.2.2.3.6 7 . 2 . 2 . 3 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 7.2.2.3.6.1 7 . 2 . 2 . 3 . 6 . 1 5.8.2 5 . 8 . 2 Document D o c u m e n t known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.2.2.3.5 7 . 2 . 2 . 3 . 5 Configuration C o n f i g u r a t i o n evaluation e v a l u a t i o n 7.2.2.3.5.1 7 . 2 . 2 . 3 . 5 . 1 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.8.3 5 . 8 . 3 EVALUATE E V A L U A T E known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S 5.8.4 5 . 8 . 4 Document D o c u m e n t released r e l e a s e d VERSIONS V E R S I O N S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t Process P r o c e s s 7.2.2.3.6 7 . 2 . 2 . 3 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 7.2.2.3.6.1 7 . 2 . 2 . 3 . 6 . 1 5.8.5 5 . 8 . 5 Document D o c u m e n t how h o w released r e l e a s e d software s o f t w a r e was w a s created c r e a t e d 5.8.6 5 . 8 . 6 Ensure E n s u r e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S are a r e complete c o m p l e t e 5.8.7 5 . 8 . 7 Archive A r c h i v e software s o f t w a r e 5.8.8 5 . 8 . 8 Assure A s s u r e repeatability r e p e a t a b i l i t y of o f software s o f t w a r e release r e l e a s e 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e Process P r o c e s s 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.2.1 6 . 2 . 1 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k None N o n e None N o n e 6.2.1.1 6 . 2 . 1 . 1 Monitor M o n i t o r feedback f e e d b a c k 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.1.2 6 . 2 . 1 . 2 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k 6.2.1.3 6 . 2 . 1 . 3 EVALUATE E V A L U A T E PROBLEM P R O B L E M REPORT’S R E P O R T ’ S effects e f f e c t s on o n SAFETY S A F E T Y 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.2 6 . 2 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.3 6 . 2 . 3 Analyse A n a l y s e CHANGE C H A N G E REQUESTS R E Q U E S T S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.4 6 . 2 . 4 CHANGE C H A N G E REQUEST R E Q U E S T approval a p p r o v a l 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.5 6 . 2 . 5 Communicate C o m m u n i c a t e to t o users u s e r s and a n d regulators r e g u l a t o r s 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n None N o n e None N o n e 6.3.1 6 . 3 . 1 Use U s e established e s t a b l i s h e d PROCESS P R O C E S S to t o implement i m p l e m e n t modification m o d i f i c a t i o n 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.3.2 6 . 3 . 2 Re-release R e - r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEM S Y S T E M 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 6.3.4 6 . 3 . 4 Risk R i s k Management M a n a g e m e n t Process P r o c e s s This T h i s is i s based b a s e d on o n ISO/IEC I S O / I E C 16085. 1 6 0 8 5 . While W h i l e there t h e r e is i s some s o m e commonality c o m m o n a l i t y it i t does d o e s not n o t address a d d r e s s the t h e specific s p e c i f i c requirements r e q u i r e m e n t s for f o r medical m e d i c a l device d e v i c e software s o f t w a r e development d e v e l o p m e n t with w i t h regard r e g a r d to t o risk r i s k management m a n a g e m e n t 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 8.1.1 8 . 1 . 1 Establish E s t a b l i s h means m e a n s to t o identify i d e n t i f y CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 82 8 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 8.2 8 . 2 Change C h a n g e control c o n t r o l 8.2.1 8 . 2 . 1 Approve A p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem p r o b l e m 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties p a r t i e s 8.1.2 8 . 1 . 2 Identify I d e n t i f y SOUP S O U P None N o n e None N o n e 8.1.3 8 . 1 . 3 Identify I d e n t i f y SYSTEM S Y S T E M 7.2.2 7 . 2 . 2 Software S o f t w a r e None N o n e configuration c o n f i g u r a t i o n Configuration C o n f i g u r a t i o n documentation d o c u m e n t a t i o n Management M a n a g e m e n t 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e 8.2.2 8 . 2 . 2 Implement I m p l e m e n t changes c h a n g e s 8.2.3 8 . 2 . 3 Verify V e r i f y changes c h a n g e s 7.2.2 7 . 2 . 2 Software S o f t w a r e 8.2.4 8 . 2 . 4 Provide P r o v i d e means m e a n s for f o r TRACEABILITY T R A C E A B I L I T Y of o f change c h a n g e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n None N o n e None N o n e None N o n e None N o n e None N o n e None N o n e None N o n e 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l 7.2.2 7 . 2 . 2 Software S o f t w a r e None N o n e process p r o c e s s Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e 9.5 9 . 5 Maintain M a i n t a i n records r e c o r d s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m None N o n e Resolution R e s o l u t i o n 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends t r e n d s 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents c o n t e n t s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n All A l l testing t e s t i n g TASKS T A S K S in i n ISO I S O 12207 1 2 2 0 7 require r e q u i r e documentation d o c u m e n t a t i o n None N o n e None N o n e None N o n e C.7 C . 7 Relationship R e l a t i o n s h i p to t o IEC I E C 61508 6 1 5 0 8 The T h e question q u e s t i o n has h a s been b e e n raised r a i s e d whether w h e t h e r this t h i s standard, s t a n d a r d , being b e i n g concerned c o n c e r n e d with w i t h the t h e design d e s i g n of o f SAFETY- S A F E T Y - critical c r i t i c a l software, s o f t w a r e , should s h o u l d follow f o l l o w the t h e principles p r i n c i p l e s of o f IEC I E C 61508. 6 1 5 0 8 . The T h e approach a p p r o a c h to t o safety s a f e t y in i n IEC I E C 62304 6 2 3 0 4 is i s fundamentally f u n d a m e n t a l l y different d i f f e r e n t than t h a n the t h e one o n e in i n IEC I E C 61508. 6 1 5 0 8 . IEC I E C 62304 6 2 3 0 4 takes t a k e s into i n t o account a c c o u n t that t h a t the t h e effectiveness e f f e c t i v e n e s s of o f medical m e d i c a l devices d e v i c e s justifies j u s t i f i e s residual r e s i d u a l risks r i s k s related r e l a t e d to t o their t h e i r use. u s e . The T h e following f o l l o w i n g explains e x p l a i n s the t h e stance s t a n c e of o f this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . IEC I E C 61508 6 1 5 0 8 addresses a d d r e s s e s 3 3 main m a i n issues: i s s u e s : RISK R I S K MANAGEMENT M A N A G E M E N T life l i f e cycle c y c l e and a n d life l i f e cycle c y c l e PROCESSES; P R O C E S S E S ; definition d e f i n i t i o n of o f Safety S a f e t y Integrity I n t e g r i t y Levels; L e v e l s ; recommendation r e c o m m e n d a t i o n of o f techniques, t e c h n i q u e s , tools t o o l s and a n d methods m e t h o d s for f o r software s o f t w a r e development d e v e l o p m e n t and a n d levels l e v e l s of o f independence i n d e p e n d e n c e of o f personnel p e r s o n n e l responsible r e s p o n s i b l e for f o r performing p e r f o r m i n g different d i f f e r e n t TASKS. T A S K S . Issue I s s u e 1) 1 ) is i s covered c o v e r e d in i n this t h i s standard s t a n d a r d by b y a a normative n o r m a t i v e reference r e f e r e n c e to t o ISO I S O 14971 1 4 9 7 1 (the ( t h e MEDICAL M E D I C A L DEVICE D E V I C E sector s e c t o r standard s t a n d a r d for f o r RISK R I S K MANAGEMENT). M A N A G E M E N T ) . The T h e effect e f f e c t of o f this t h i s reference r e f e r e n c e is i s to t o adopt a d o p t ISO I S O 14971’s 1 4 9 7 1 ’ s approach a p p r o a c h to t o RISK R I S K MANAGEMENT M A N A G E M E N T as a s an a n integral i n t e g r a l part p a r t of o f the t h e software s o f t w a r e PROCESS P R O C E S S for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . For F o r issue i s s u e 2), 2 ) , this t h i s standard s t a n d a r d takes t a k e s a a simpler s i m p l e r approach a p p r o a c h than t h a n IEC I E C 61508. 6 1 5 0 8 . The T h e latter l a t t e r classifies c l a s s i f i e s software s o f t w a r e into i n t o 4 4 “Safety “ S a f e t y Integrity I n t e g r i t y Levels” L e v e l s ” defined d e f i n e d in i n terms t e r m s of o f reliability r e l i a b i l i t y objectives. o b j e c t i v e s . The T h e reliability r e l i a b i l i t y objectives o b j e c t i v e s are a r e identified i d e n t i f i e d after a f t e r RISK R I S K ANALYSIS, A N A L Y S I S , which w h i c h quantifies q u a n t i f i e s both b o t h the t h e severity s e v e r i t y and a n d the t h e probability p r o b a b i l i t y of o f HARM H A R M caused c a u s e d by b y a a failure f a i l u r e of o f the t h e software. s o f t w a r e . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 83 8 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 This T h i s standard s t a n d a r d simplifies s i m p l i f i e s issue i s s u e 2) 2 ) by b y disallowing d i s a l l o w i n g defining d e f i n i n g the t h e classification c l a s s i f i c a t i o n into i n t o 3 3 software s o f t w a r e safety s a f e t y classes c l a s s e s based b a s e d on o n the t h e RISK R I S K caused c a u s e d by b y a a failure f a i l u r e consideration c o n s i d e r a t i o n of o f probability p r o b a b i l i t y of o f software s o f t w a r e failure f a i l u r e prior p r i o r to t o classification c l a s s i f i c a t i o n . . Classification C l a s s i f i c a t i o n into i n t o 3 3 software s o f t w a r e safety s a f e t y classes c l a s s e s is i s based b a s e d only o n l y on o n the t h e severity s e v e r i t y of o f that t h a t HARM H A R M caused c a u s e d by b y a a failure. f a i l u r e . After A f t e r classification, c l a s s i f i c a t i o n , different d i f f e r e n t PROCESSES P R O C E S S E S are a r e required r e q u i r e d for f o r different d i f f e r e n t software s o f t w a r e safety s a f e t y classes: c l a s s e s : the t h e intention i n t e n t i o n is i s to t o further f u r t h e r reduce r e d u c e the t h e probability p r o b a b i l i t y (and/or ( a n d / o r the t h e severity) s e v e r i t y ) of o f failure f a i l u r e of o f the t h e software. s o f t w a r e . Issue I s s u e 3) 3 ) is i s not n o t addressed a d d r e s s e d by b y this t h i s standard. s t a n d a r d . Readers R e a d e r s of o f the t h e standard s t a n d a r d are a r e encouraged e n c o u r a g e d to t o use u s e IEC I E C 61508 6 1 5 0 8 as a s a a source s o u r c e for f o r good g o o d software s o f t w a r e methods, m e t h o d s , techniques t e c h n i q u e s and a n d tools, t o o l s , while w h i l e recognising r e c o g n i s i n g that t h a t other o t h e r approaches, a p p r o a c h e s , both b o t h present p r e s e n t and a n d future, f u t u r e , can c a n provide p r o v i d e equally e q u a l l y good g o o d results. r e s u l t s . This T h i s standard s t a n d a r d makes m a k e s no n o recommendation r e c o m m e n d a t i o n concerning c o n c e r n i n g independence i n d e p e n d e n c e of o f people p e o p l e responsible r e s p o n s i b l e for f o r one o n e software s o f t w a r e ACTIVITY A C T I V I T Y (for ( f o r example e x a m p l e VERIFICATION) V E R I F I C A T I O N ) from f r o m those t h o s e responsible r e s p o n s i b l e for f o r another a n o t h e r (for ( f o r example e x a m p l e design). d e s i g n ) . In I n particular, p a r t i c u l a r , this t h i s standard s t a n d a r d makes m a k e s no n o requirement r e q u i r e m e n t for f o r an a n independent i n d e p e n d e n t safety s a f e t y assessor, a s s e s s o r , since s i n c e this t h i s is i s a a matter m a t t e r for f o r ISO I S O 14971. 1 4 9 7 1 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 84 8 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x D D (informative) ( i n f o r m a t i v e ) Implementation I m p l e m e n t a t i o n D.1 D . 1 Introduction I n t r o d u c t i o n This T h i s annex a n n e x gives g i v e s an a n overview o v e r v i e w of o f how h o w this t h i s standard s t a n d a r d can c a n be b e implemented i m p l e m e n t e d into i n t o MANUFACTURERS’ M A N U F A C T U R E R S ’ PROCESSES. P R O C E S S E S . It I t also a l s o considers c o n s i d e r s that t h a t other o t h e r standards s t a n d a r d s like l i k e ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] require r e q u i r e adequate a d e q u a t e and a n d comparable c o m p a r a b l e PROCESSES. P R O C E S S E S . D.2 D . 2 Quality Q u a l i t y management m a n a g e m e n t system s y s t e m For F o r MANUFACTURERS M A N U F A C T U R E R S of o f MEDICAL M E D I C A L DEVICES, D E V I C E S , including i n c l u d i n g MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E in i n the t h e context c o n t e x t of o f this t h i s standard, s t a n d a r d , the t h e establishment e s t a b l i s h m e n t of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m (QMS) ( Q M S ) is i s required r e q u i r e d in i n 4.1. 4 . 1 . This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t the t h e QMS Q M S necessarily n e c e s s a r i l y has h a s to t o be b e certified. c e r t i f i e d . D.3 D . 3 EVALUATE E V A L U A T E quality q u a l i t y management m a n a g e m e n t PROCESSES P R O C E S S E S It I t is i s recommended r e c o m m e n d e d to t o EVALUATE E V A L U A T E how h o w well w e l l the t h e established e s t a b l i s h e d and a n d documented d o c u m e n t e d PROCESSES P R O C E S S E S of o f the t h e QMS Q M S already a l r e a d y cover c o v e r the t h e PROCESSES P R O C E S S E S of o f the t h e software s o f t w a r e life l i f e cycle, c y c l e , by b y means m e a n s of o f audits, a u d i t s , inspections, i n s p e c t i o n s , or o r analyses a n a l y s e s under u n d e r the t h e responsibility r e s p o n s i b i l i t y of o f the t h e MANUFACTURER. M A N U F A C T U R E R . Any A n y identified i d e n t i f i e d gaps g a p s can c a n be b e accommodated a c c o m m o d a t e d by b y extending e x t e n d i n g the t h e QM Q M PROCESSES, P R O C E S S E S , or o r can c a n be b e separately s e p a r a t e l y described. d e s c r i b e d . If I f the t h e MANUFACTURER M A N U F A C T U R E R already a l r e a d y has h a s PROCESS P R O C E S S descriptions d e s c r i p t i o n s available a v a i l a b l e which w h i c h regulate r e g u l a t e the t h e development, d e v e l o p m e n t , VERIFICATION V E R I F I C A T I O N and a n d validation v a l i d a t i o n of o f software, s o f t w a r e , then t h e n these t h e s e should s h o u l d also a l s o be b e EVALUATED E V A L U A T E D to t o determine d e t e r m i n e how h o w well w e l l they t h e y agree a g r e e with w i t h this t h i s standard. s t a n d a r d . D.4 D . 4 Integrating I n t e g r a t i n g requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d into i n t o the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S quality q u a l i t y management m a n a g e m e n t PROCESSES P R O C E S S E S This T h i s standard s t a n d a r d can c a n be b e implemented i m p l e m e n t e d by b y adapting a d a p t i n g or o r extending e x t e n d i n g the t h e PROCESSES P R O C E S S E S already a l r e a d y installed i n s t a l l e d in i n the t h e QMS Q M S system, s y s t e m , or o r integrating i n t e g r a t i n g new n e w PROCESSES. P R O C E S S E S . This T h i s standard s t a n d a r d does d o e s not n o t specify s p e c i f y how h o w this t h i s is i s to t o be b e done; d o n e ; the t h e MANUFACTURER M A N U F A C T U R E R is i s free f r e e to t o do d o this t h i s in i n any a n y suitable s u i t a b l e way. w a y . The T h e MANUFACTURER M A N U F A C T U R E R is i s responsible r e s p o n s i b l e for f o r ensuring e n s u r i n g that t h a t the t h e PROCESSES P R O C E S S E S described d e s c r i b e d in i n this t h i s standard s t a n d a r d are a r e suitably s u i t a b l y put p u t into i n t o action a c t i o n when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s developed d e v e l o p e d by b y Original O r i g i n a l Equipment E q u i p m e n t Manufacturers M a n u f a c t u r e r s (OEM) ( O E M ) or o r sub-contractors s u b - c o n t r a c t o r s not n o t having h a v i n g their t h e i r own o w n documented d o c u m e n t e d QMS. Q M S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . D.5 D . 5 Checklist C h e c k l i s t for f o r small s m a l l MANUFACTURERS M A N U F A C T U R E R S without w i t h o u t a a certified c e r t i f i e d QMS Q M S The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d determine d e t e r m i n e the t h e highest h i g h e s t software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n (A, ( A , B B or o r C) C ) of o f the t h e software. s o f t w a r e . Table T a b l e D.1 D . 1 lists l i s t s all a l l ACTIVITIES A C T I V I T I E S described d e s c r i b e d in i n this t h i s standard. s t a n d a r d . The T h e reference r e f e r e n c e to t o ISO I S O 13485 1 3 4 8 5 should s h o u l d help h e l p to t o define d e f i n e the t h e place p l a c e in i n the t h e QMS. Q M S . Based B a s e d on o n the t h e required r e q u i r e d software s o f t w a r e safety s a f e t y class, c l a s s , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d assess a s s e s s each e a c h required r e q u i r e d ACTIVITY A C T I V I T Y against a g a i n s t the t h e existing e x i s t i n g PROCESSES. P R O C E S S E S . If I f the t h e requirement r e q u i r e m e n t is i s already a l r e a d y covered, c o v e r e d , a a reference r e f e r e n c e to t o the t h e relevant r e l e v a n t PROCESS P R O C E S S descriptions d e s c r i p t i o n s should s h o u l d be b e given. g i v e n . If I f there t h e r e is i s discrepancy, d i s c r e p a n c y , an a n action a c t i o n is i s needed n e e d e d to t o improve i m p r o v e the t h e PROCESS. P R O C E S S . The T h e list l i s t can c a n also a l s o be b e used u s e d for f o r an a n EVALUATION E V A L U A T I O N of o f the t h e PROCESSES P R O C E S S E S after a f t e r the t h e action a c t i o n has h a s been b e e n performed. p e r f o r m e d . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 85 8 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e D.1 D . 1 – – Checklist C h e c k l i s t for f o r small s m a l l companies c o m p a n i e s without w i t h o u t a a certified c e r t i f i e d QMS Q M S ACTIVITY A C T I V I T Y Related R e l a t e d clause c l a u s e of o f ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 Covered C o v e r e d by b y existing e x i s t i n g procedure? p r o c e d u r e ? If I f yes: y e s : Reference R e f e r e n c e Actions A c t i o n s to t o be b e taken t a k e n 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 7.3.1 7 . 3 . 1 Design D e s i g n and a n d development d e v e l o p m e n t planning p l a n n i n g Yes/No Y e s / N o 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.3.2 7 . 3 . 2 Design D e s i g n and a n d development d e v e l o p m e n t inputs i n p u t s Yes/No Y e s / N o 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n Yes/No Y e s / N o 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n Yes/No Y e s / N o 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n Yes/No Y e s / N o 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g Yes/No Y e s / N o 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.3.3 7 . 3 . 3 Design D e s i g n and a n d development d e v e l o p m e n t outputs o u t p u t s 7.3.4 7 . 3 . 4 Design D e s i g n and a n d development d e v e l o p m e n t review r e v i e w Yes/No Y e s / N o 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n Yes/No Y e s / N o 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 7.3.7 7 . 3 . 7 Control C o n t r o l of o f design d e s i g n and a n d development d e v e l o p m e n t changes c h a n g e s Yes/No Y e s / N o 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s Yes/No Y e s / N o 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n Yes/No Y e s / N o 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s Yes/No Y e s / N o 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s Yes/No Y e s / N o 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s Yes/No Y e s / N o 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s Yes/No Y e s / N o 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d traceability t r a c e a b i l i t y Yes/No Y e s / N o 8.2 8 . 2 Change C h a n g e control c o n t r o l 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d traceability t r a c e a b i l i t y Yes/No Y e s / N o 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g Yes/No Y e s / N o 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S Yes/No Y e s / N o Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 86 8 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Bibliography B i b l i o g r a p h y IEC I E C 60601-1:2005, 6 0 6 0 1 - 1 : 2 0 0 5 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s for f o r basic b a s i c safety s a f e t y and a n d essential e s s e n t i a l performance p e r f o r m a n c e IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 IEC I E C 60601-1-4:1996, 6 0 6 0 1 - 1 - 4 : 1 9 9 6 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s for f o r safety s a f e t y – – 4.Collateral 4 . C o l l a t e r a l standard: s t a n d a r d : Programmable P r o g r a m m a b l e electrical e l e c t r i c a l medical m e d i c a l systems s y s t e m s (withdrawn) ( w i t h d r a w n ) IEC I E C 60601-1-4:1996/AMD1:1999 6 0 6 0 1 - 1 - 4 : 1 9 9 6 / A M D 1 : 1 9 9 9 IEC I E C 60601-1-6, 6 0 6 0 1 - 1 - 6 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1-6: 1 - 6 : General G e n e r a l requirements r e q u i r e m e n t s for f o r basic b a s i c safety s a f e t y and a n d essential e s s e n t i a l performance p e r f o r m a n c e – – Collateral C o l l a t e r a l standard: s t a n d a r d : Usability U s a b i l i t y IEC I E C 61508-3, 6 1 5 0 8 - 3 , Functional F u n c t i o n a l safety s a f e t y of o f electrical/electronic/programmable e l e c t r i c a l / e l e c t r o n i c / p r o g r a m m a b l e electronic e l e c t r o n i c safety- s a f e t y - related r e l a t e d systems s y s t e m s – – Part P a r t 3: 3 : Software S o f t w a r e requirements r e q u i r e m e n t s IEC I E C 61010-1:2001 6 1 0 1 0 - 1 : 2 0 0 1 2010, 2 0 1 0 , Safety S a f e t y requirements r e q u i r e m e n t s for f o r electrical e l e c t r i c a l equipment e q u i p m e n t for f o r measurement, m e a s u r e m e n t , control, c o n t r o l , and a n d laboratory l a b o r a t o r y use u s e – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s ISO I S O 9000:2005, 9 0 0 0 : 2 0 0 5 , Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Fundamentals F u n d a m e n t a l s and a n d vocabulary v o c a b u l a r y ISO I S O 9001:2000 9 0 0 1 : 2 0 0 0 2008, 2 0 0 8 , Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Requirements R e q u i r e m e n t s ISO I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , Medical M e d i c a l devices d e v i c e s – – Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Requirements R e q u i r e m e n t s for f o r regulatory r e g u l a t o r y purposes p u r p o s e s ISO/IEC I S O / I E C 9126-1:2001, 9 1 2 6 - 1 : 2 0 0 1 , Software S o f t w a r e engineering e n g i n e e r i n g — — Product P r o d u c t quality q u a l i t y — — Part P a r t 1: 1 : Quality Q u a l i t y model m o d e l [9] [ 9 ] ISO/IEC I S O / I E C 12207:1995 1 2 2 0 7 : 1 9 9 5 2008, 2 0 0 8 , Information I n f o r m a t i o n technology t e c h n o l o g y Systems S y s t e m s and a n d software s o f t w a r e engineering e n g i n e e r i n g – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s Amendment A m e n d m e n t 1 1 (2002) ( 2 0 0 2 ) Amendment A m e n d m e n t 2 2 (2004) ( 2 0 0 4 ) ISO/IEC I S O / I E C 14764:1999, 1 4 7 6 4 : 1 9 9 9 , Information I n f o r m a t i o n technology t e c h n o l o g y – – Software S o f t w a r e maintenance m a i n t e n a n c e Software S o f t w a r e Engineering E n g i n e e r i n g – – Software S o f t w a r e Life L i f e Cycle C y c l e Processes P r o c e s s e s – – Maintenance M a i n t e n a n c e ISO/IEC I S O / I E C 15504-5:2012, 1 5 5 0 4 - 5 : 2 0 1 2 , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Part P a r t 5: 5 : An A n exemplar e x e m p l a r software s o f t w a r e life l i f e cycle c y c l e process p r o c e s s assessment a s s e s s m e n t model m o d e l ISO/IEC I S O / I E C 25010:2011, 2 5 0 1 0 : 2 0 1 1 , Systems S y s t e m s and a n d software s o f t w a r e engineering e n g i n e e r i n g – – System S y s t e m and a n d software s o f t w a r e Quality Q u a l i t y Requirements R e q u i r e m e n t s and a n d Evaluation E v a l u a t i o n (SQuaRE) ( S Q u a R E ) – – System S y s t e m and a n d software s o f t w a r e quality q u a l i t y models m o d e l s ISO/IEC I S O / I E C 33001:— 3 3 0 0 1 : — 2) 2 ) , , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Concepts C o n c e p t s and a n d terminology t e r m i n o l o g y ISO/IEC I S O / I E C 33004:— 3 3 0 0 4 : — 2) 2 ) , , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Requirements R e q u i r e m e n t s for f o r process p r o c e s s reference, r e f e r e n c e , process p r o c e s s assessment a s s e s s m e n t and a n d maturity m a t u r i t y models m o d e l s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . ISO/IEC I S O / I E C 90003:2004 9 0 0 0 3 : 2 0 0 4 2014, 2 0 1 4 , Software S o f t w a r e engineering e n g i n e e r i n g – – Guidelines G u i d e l i n e s for f o r the t h e application a p p l i c a t i o n of o f ISO I S O 9001:2000 9 0 0 1 : 2 0 0 0 2008 2 0 0 8 to t o computer c o m p u t e r software s o f t w a r e ISO/IEC I S O / I E C Guide G u i d e 51:1999 5 1 : 1 9 9 9 2014, 2 0 1 4 , Safety S a f e t y aspects a s p e c t s – – Guidelines G u i d e l i n e s for f o r their t h e i r inclusion i n c l u s i o n in i n standards s t a n d a r d s IEEE I E E E 610.12:1990, 6 1 0 . 1 2 : 1 9 9 0 , IEEE I E E E standard s t a n d a r d glossary g l o s s a r y of o f software s o f t w a r e engineering e n g i n e e r i n g terminology t e r m i n o l o g y IEEE I E E E 1044:1993 1 0 4 4 : 1 9 9 3 2009, 2 0 0 9 , IEEE I E E E standard s t a n d a r d classification c l a s s i f i c a t i o n for f o r software s o f t w a r e anomalies a n o m a l i e s 2 2 To T o be b e published. p u b l i s h e d . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 87 8 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 U.S. U . S . Department D e p a r t m e n t Of O f Health H e a l t h and a n d Human H u m a n Services, S e r v i c e s , Food F o o d and a n d Drug D r u g Administration, A d m i n i s t r a t i o n , Guidance G u i d a n c e for f o r the t h e Content C o n t e n t of o f Premarket P r e m a r k e t Submissions S u b m i s s i o n s for f o r Software S o f t w a r e Contained C o n t a i n e d in i n Medical M e d i c a l Devices, D e v i c e s , May M a y 11, 1 1 , 2005, 2 0 0 5 , <://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc < : / / w w w . f d a . g o v / M e d i c a l D e v i c e s / D e v i c e R e g u l a t i o n a n d G u i d a n c e / G u i d a n c e D o c u m e n t s / u c m089543.htm> m 0 8 9 5 4 3 . h t m > U.S. U . S . Department D e p a r t m e n t Of O f Health H e a l t h and a n d Human H u m a n Services, S e r v i c e s , Food F o o d and a n d Drug D r u g Administration, A d m i n i s t r a t i o n , General G e n e r a l Principles P r i n c i p l e s of o f Software S o f t w a r e Validation; V a l i d a t i o n ; Final F i n a l Guidance G u i d a n c e for f o r Industry I n d u s t r y and a n d FDA F D A Staff, S t a f f , January J a n u a r y 11, 1 1 , 2002, 2 0 0 2 , <http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf> < h t t p : / / w w w . f d a . g o v / d o w n l o a d s / R e g u l a t o r y I n f o r m a t i o n / G u i d a n c e s / u c m 1 2 6 9 5 5 . p d f > IEC I E C 62366-1:2015, 6 2 3 6 6 - 1 : 2 0 1 5 , Medical M e d i c a l devices d e v i c e s – – Part P a r t 1: 1 : Application A p p l i c a t i o n of o f usability u s a b i l i t y engineering e n g i n e e r i n g to t o medical m e d i c a l devices d e v i c e s IEC I E C 82304-1:— 8 2 3 0 4 - 1 : — 3), 3 ) , Healthcare H e a l t h c a r e Software S o f t w a r e Systems S y s t e m s – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 3 3 In I n preparation. p r e p a r a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 88 8 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Index I n d e x of o f defined d e f i n e d terms t e r m s ACTIVITY, A C T I V I T Y , 15, 1 5 , 17, 1 7 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 33, 3 3 , 43, 4 3 , 59, 5 9 , 65, 6 5 , 67, 6 7 , 69, 6 9 , 73, 7 3 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 87, 8 7 , 89, 8 9 , 95, 9 5 , 113, 1 1 3 , 133, 1 3 3 , 145 1 4 5 Change C h a n g e control, c o n t r o l , 101 1 0 1 Change C h a n g e request, r e q u e s t , 61 6 1 Completion C o m p l e t i o n of, o f , 49 4 9 Configuration C o n f i g u r a t i o n identification, i d e n t i f i c a t i o n , 101 1 0 1 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 35 3 5 Configuration C o n f i g u r a t i o n status s t a t u s accounting, a c c o u n t i n g , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 Deliverable, D e l i v e r a b l e , 19 1 9 Design D e s i g n and a n d maintenance, m a i n t e n a n c e , 11 1 1 Hazard H a z a r d identification, i d e n t i f i c a t i o n , 11 1 1 Maintenance, M a i n t e n a n c e , 51 5 1 Mapping, M a p p i n g , 15 1 5 Modification M o d i f i c a t i o n implementation, i m p l e m e n t a t i o n , 97 9 7 Planning, P l a n n i n g , 83, 8 3 , 85 8 5 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis, a n a l y s i s , 95 9 5 Problem P r o b l e m resolution, r e s o l u t i o n , 31, 3 1 , 53, 5 3 , 103 1 0 3 Required, R e q u i r e d , 15, 1 5 , 147 1 4 7 Requirements, R e q u i r e m e n t s , 17 1 7 Requirements R e q u i r e m e n t s analysis, a n a l y s i s , 39 3 9 Risk R i s k analysis, a n a l y s i s , 55 5 5 Risk R i s k management, m a n a g e m e n t , 33, 3 3 , 47, 4 7 , 59, 5 9 , 79, 7 9 , 81, 8 1 , 99 9 9 Software S o f t w a r e architectural a r c h i t e c t u r a l design, d e s i g n , 87 8 7 Software S o f t w a r e detailed d e t a i l e d design, d e s i g n , 89 8 9 Software S o f t w a r e development, d e v e l o p m e n t , 11 1 1 Software S o f t w a r e integration, i n t e g r a t i o n , 93 9 3 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing, t e s t i n g , 91 9 1 Software S o f t w a r e maintenance, m a i n t e n a n c e , 95 9 5 Software S o f t w a r e release, r e l e a s e , 95 9 5 Software S o f t w a r e requirements r e q u i r e m e n t s analysis, a n a l y s i s , 85 8 5 Software S o f t w a r e system s y s t e m testing, t e s t i n g , 93 9 3 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification, v e r i f i c a t i o n , 89 8 9 Testing, T e s t i n g , 45, 4 5 , 47 4 7 Verification, V e r i f i c a t i o n , 33 3 3 ANOMALY, A N O M A L Y , 45, 4 5 , 47, 4 7 , 49, 4 9 , 55, 5 5 , 65, 6 5 , 93 9 3 Definition, D e f i n i t i o n , 19 1 9 ARCHITECTURE, A R C H I T E C T U R E , 39, 3 9 , 41, 4 1 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 99, 9 9 , 113, 1 1 3 , 133 1 3 3 Definition, D e f i n i t i o n , 19 1 9 CHANGE C H A N G E REQUEST, R E Q U E S T , 53, 5 3 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 97, 9 7 , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 CONFIGURATION C O N F I G U R A T I O N ITEM, I T E M , 27, 2 7 , 35, 3 5 , 49, 4 9 , 59, 5 9 , 61, 6 1 , 97, 9 7 , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 SOUP, S O U P , 31, 3 1 , 59 5 9 DELIVERABLE, D E L I V E R A B L E , 25, 2 5 , 31, 3 1 , 33 3 3 Definition, D e f i n i t i o n , 19 1 9 EVALUATION, E V A L U A T I O N , 41, 4 1 , 45, 4 5 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 87, 8 7 , 89, 8 9 , 93, 9 3 , 95, 9 5 , 99, 9 9 , 147, 1 4 7 , 149 1 4 9 Re-, R e - , 39 3 9 HARM, H A R M , 21, 2 1 , 23, 2 3 , 73, 7 3 , 81, 8 1 , 145 1 4 5 Definition, D e f i n i t i o n , 21 2 1 HAZARD, H A Z A R D , 11, 1 1 , 23, 2 3 , 29, 2 9 , 57, 5 7 , 67, 6 7 , 69, 6 9 , 79, 7 9 , 83, 8 3 , 93, 9 3 , 97, 9 7 , 99, 9 9 , 129 1 2 9 Definition, D e f i n i t i o n , 21 2 1 Unforeseen, U n f o r e s e e n , 87 8 7 MANUFACTURER, M A N U F A C T U R E R , 15, 1 5 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 35, 3 5 , 37, 3 7 , 39, 3 9 , 41, 4 1 , 43, 4 3 , 45, 4 5 , 47, 4 7 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 59, 5 9 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 107, 1 0 7 , 147 1 4 7 Definition, D e f i n i t i o n , 21 2 1 MEDICAL M E D I C A L DEVICE, D E V I C E , 11, 1 1 , 17, 1 7 , 21, 2 1 , 27, 2 7 , 35, 3 5 , 39, 3 9 , 41, 4 1 , 55, 5 5 , 69, 6 9 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 85, 8 5 , 87, 8 7 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 99, 9 9 , 105, 1 0 5 , 129, 1 2 9 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Definition, D e f i n i t i o n , 21 2 1 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , 11, 1 1 , 13, 1 3 , 17, 1 7 , 27, 2 7 , 35, 3 5 , 37, 3 7 , 39, 3 9 , 51, 5 1 , 67, 6 7 , 73, 7 3 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 83, 8 3 , 85, 8 5 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 101, 1 0 1 , 105, 1 0 5 , 145, 1 4 5 , 147 1 4 7 Change, C h a n g e , 59 5 9 Definition, D e f i n i t i o n , 21 2 1 PROBLEM P R O B L E M REPORT, R E P O R T , 51, 5 1 , 53, 5 3 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 95, 9 5 , 97 9 7 Classification, C l a s s i f i c a t i o n , 61 6 1 Definition, D e f i n i t i o n , 21 2 1 PROCESS, P R O C E S S , 13, 1 3 , 15, 1 5 , 17, 1 7 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 67, 6 7 , 69, 6 9 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 113, 1 1 3 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Acceptance, A c c e p t a n c e , 61 6 1 Change C h a n g e control, c o n t r o l , 61, 6 1 , 63 6 3 Classification, C l a s s i f i c a t i o n , 133 1 3 3 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 51, 5 1 , 89, 8 9 , 113 1 1 3 Decision-making, D e c i s i o n - m a k i n g , 77 7 7 Definition, D e f i n i t i o n , 23 2 3 Development, D e v e l o p m e n t , 27, 2 7 , 81, 8 1 , 95, 9 5 , 113 1 1 3 Existing, E x i s t i n g , 31 3 1 Improvement, I m p r o v e m e n t , 149 1 4 9 Life L i f e cycle, c y c l e , 11, 1 1 , 133, 1 3 3 , 143 1 4 3 Maintenance, M a i n t e n a n c e , 51, 5 1 , 53, 5 3 , 113 1 1 3 Mapping, M a p p i n g , 15 1 5 Modification, M o d i f i c a t i o n , 97 9 7 Omission O m i s s i o n of, o f , 81 8 1 Output, O u t p u t , 75 7 5 Physiological, P h y s i o l o g i c a l , 21 2 1 Problem P r o b l e m resolution, r e s o l u t i o n , 35, 3 5 , 45, 4 5 , 47, 4 7 , 51, 5 1 , 53, 5 3 , 63, 6 3 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 113 1 1 3 Quality Q u a l i t y management, m a n a g e m e n t , 147 1 4 7 Required, R e q u i r e d , 15, 1 5 , 147 1 4 7 Requirements, R e q u i r e m e n t s , 17, 1 7 , 29 2 9 Risk R i s k analysis, a n a l y s i s , 73 7 3 Risk R i s k management, m a n a g e m e n t , 11, 1 1 , 23, 2 3 , 29, 2 9 , 33, 3 3 , 51, 5 1 , 63, 6 3 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 89, 8 9 , 99, 9 9 , 109, 1 0 9 , 113, 1 1 3 , 129, 1 2 9 , 133 1 3 3 Software, S o f t w a r e , 79, 7 9 , 145 1 4 5 Software S o f t w a r e development, d e v e l o p m e n t , 11, 1 1 , 27, 2 7 , 31, 3 1 , 53, 5 3 , 73 7 3 Software S o f t w a r e maintenance, m a i n t e n a n c e , 11, 1 1 , 95, 9 5 , 97 9 7 Software S o f t w a r e release, r e l e a s e , 133 1 3 3 System S y s t e m requirements, r e q u i r e m e n t s , 87 8 7 Verification, V e r i f i c a t i o n , 27 2 7 REGRESSION R E G R E S S I O N TESTING, T E S T I N G , 45, 4 5 , 65, 6 5 , 93 9 3 Definition, D e f i n i t i o n , 23 2 3 RISK, R I S K , 23, 2 3 , 67, 6 7 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 91, 9 1 , 97, 9 7 , 99 9 9 Definition, D e f i n i t i o n , 23 2 3 Non-serious N o n - s e r i o u s injury, i n j u r y , 29 2 9 Reasonably R e a s o n a b l y foreseeable, f o r e s e e a b l e , 79 7 9 Risk R i s k control, c o n t r o l , 23 2 3 Serious S e r i o u s injury, i n j u r y , 29 2 9 SOUP, S O U P , 33 3 3 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 89 8 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Unacceptable, U n a c c e p t a b l e , 11, 1 1 , 25, 2 5 , 49 4 9 RISK R I S K ANALYSIS, A N A L Y S I S , 39, 3 9 , 55, 5 5 , 67, 6 7 , 73, 7 3 , 79, 7 9 , 87, 8 7 , 99, 9 9 , 145 1 4 5 Definition, D e f i n i t i o n , 23 2 3 RISK R I S K CONTROL C O N T R O L Activity, A c t i v i t y , 11 1 1 Definition, D e f i n i t i o n , 23 2 3 Hardware H a r d w a r e measure, m e a s u r e , 29 2 9 Measure, M e a s u r e , 29, 2 9 , 31, 3 1 , 37, 3 7 , 43, 4 3 , 45, 4 5 , 55, 5 5 , 57, 5 7 , 59, 5 9 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 93, 9 3 , 97, 9 7 , 99 9 9 Requirements, R e q u i r e m e n t s , 39, 3 9 , 41, 4 1 , 57, 5 7 , 99 9 9 Segregation, S e g r e g a t i o n , 41 4 1 RISK R I S K MANAGEMENT, M A N A G E M E N T , 11, 1 1 , 23, 2 3 , 29, 2 9 , 33, 3 3 , 47, 4 7 , 51, 5 1 , 53, 5 3 , 59, 5 9 , 63, 6 3 , 67, 6 7 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 99, 9 9 , 109, 1 0 9 , 113, 1 1 3 , 129, 1 2 9 , 133, 1 3 3 , 145 1 4 5 Definition, D e f i n i t i o n , 23 2 3 Medical M e d i c a l device, d e v i c e , 75 7 5 Report, R e p o r t , 57 5 7 RISK R I S K MANAGEMENT M A N A G E M E N T FILE, F I L E , 17, 1 7 , 29, 2 9 , 55, 5 5 , 57, 5 7 , 63, 6 3 , 87, 8 7 , 89, 8 9 , 97 9 7 Definition, D e f i n i t i o n , 23 2 3 SAFETY, S A F E T Y , 11, 1 1 , 51, 5 1 , 63, 6 3 , 69, 6 9 , 77, 7 7 , 81, 8 1 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 103, 1 0 3 , 133, 1 3 3 , 143 1 4 3 Definition, D e f i n i t i o n , 25 2 5 SECURITY, S E C U R I T Y , 63 6 3 Definition, D e f i n i t i o n , 25 2 5 Requirements, R e q u i r e m e n t s , 37 3 7 SERIOUS S E R I O U S INJURY, I N J U R Y , 29, 2 9 , 83 8 3 Definition, D e f i n i t i o n , 25 2 5 Non-, N o n - , 29, 2 9 , 83 8 3 SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL, M O D E L , 31, 3 1 , 73, 7 3 , 133 1 3 3 Definition, D e f i n i t i o n , 25 2 5 SOFTWARE S O F T W A R E ITEM, I T E M , 25, 2 5 , 27, 2 7 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 39, 3 9 , 41, 4 1 , 43, 4 3 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 61, 6 1 , 65, 6 5 , 67, 6 7 , 69, 6 9 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 87, 8 7 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 97, 9 7 , 101, 1 0 1 , 111 1 1 1 Changed, C h a n g e d , 53 5 3 Definition, D e f i n i t i o n , 25 2 5 Integration, I n t e g r a t i o n , 43, 4 3 , 45 4 5 Partitioning, P a r t i t i o n i n g , 81 8 1 Performance, P e r f o r m a n c e , 45 4 5 Segregation, S e g r e g a t i o n , 41 4 1 SOUP, S O U P , 27, 2 7 , 33, 3 3 , 39 3 9 Software S o f t w a r e Of O f Unknown U n k n o w n Provenance P r o v e n a n c e See S e e SOUP, S O U P , 27 2 7 SOFTWARE S O F T W A R E PRODUCT, P R O D U C T , 19, 1 9 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 59, 5 9 , 61, 6 1 , 65, 6 5 , 73, 7 3 , 77, 7 7 , 85, 8 5 , 89, 8 9 , 91, 9 1 , 97 9 7 Definition, D e f i n i t i o n , 25 2 5 Released, R e l e a s e d , 51, 5 1 , 53 5 3 SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , 21, 2 1 , 25, 2 5 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 37, 3 7 , 43, 4 3 , 53, 5 3 , 59, 5 9 , 61, 6 1 , 69, 6 9 , 73, 7 3 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 89, 8 9 , 93, 9 3 , 95, 9 5 , 111 1 1 1 Definition, D e f i n i t i o n , 25 2 5 Integration, I n t e g r a t i o n , 43 4 3 Requirements, R e q u i r e m e n t s , 35 3 5 Testing, T e s t i n g , 45, 4 5 , 47 4 7 SOFTWARE S O F T W A R E UNIT, U N I T , 25, 2 5 , 41, 4 1 , 43, 4 3 , 73, 7 3 , 77, 7 7 , 89, 8 9 , 91 9 1 Definition, D e f i n i t i o n , 27 2 7 Integration, I n t e g r a t i o n , 43 4 3 Verification, V e r i f i c a t i o n , 43 4 3 SOFTWARE S O F T W A R E UNIT U N I T Verification, V e r i f i c a t i o n , 41 4 1 SOUP, S O U P , 33, 3 3 , 35, 3 5 , 39, 3 9 , 41, 4 1 , 51, 5 1 , 55, 5 5 , 59, 5 9 , 75, 7 5 , 85 8 5 Change, C h a n g e , 59 5 9 Configuration C o n f i g u r a t i o n item, i t e m , 31 3 1 Definition, D e f i n i t i o n , 27 2 7 Designator, D e s i g n a t o r , 59 5 9 Software S o f t w a r e item, i t e m , 33 3 3 SYSTEM, S Y S T E M , 11, 1 1 , 19, 1 9 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 31, 3 1 , 37, 3 7 , 39, 3 9 , 65, 6 5 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 101, 1 0 1 , 133 1 3 3 Configuration, C o n f i g u r a t i o n , 61 6 1 Definition, D e f i n i t i o n , 27 2 7 Development D e v e l o p m e n t plan, p l a n , 31 3 1 Existing, E x i s t i n g , 51 5 1 Released, R e l e a s e d , 53 5 3 Requirements, R e q u i r e m e n t s , 33, 3 3 , 35, 3 5 , 39, 3 9 , 41 4 1 TASK, T A S K , 15, 1 5 , 17, 1 7 , 19, 1 9 , 23, 2 3 , 25, 2 5 , 29, 2 9 , 31, 3 1 , 73, 7 3 , 83, 8 3 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 143 1 4 3 Completion C o m p l e t i o n of, o f , 49 4 9 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 35 3 5 Definition, D e f i n i t i o n , 27 2 7 Deliverable, D e l i v e r a b l e , 19 1 9 Design D e s i g n and a n d maintenance, m a i n t e n a n c e , 11 1 1 Maintenance, M a i n t e n a n c e , 51 5 1 Mapping, M a p p i n g , 15 1 5 Required, R e q u i r e d , 15 1 5 Requirements, R e q u i r e m e n t s , 17 1 7 Risk R i s k management, m a n a g e m e n t , 33 3 3 Verification, V e r i f i c a t i o n , 33 3 3 TRACEABILITY, T R A C E A B I L I T Y , 31, 3 1 , 57, 5 7 , 85, 8 5 , 87 8 7 Definition, D e f i n i t i o n , 27 2 7 Verification, V e r i f i c a t i o n , 25, 2 5 , 33, 3 3 , 35, 3 5 , 41, 4 1 , 43, 4 3 , 47, 4 7 , 49, 4 9 , 57, 5 7 , 61, 6 1 , 63, 6 3 , 69, 6 9 , 73, 7 3 , 75, 7 5 , 87, 8 7 , 91, 9 1 , 93, 9 3 , 97, 9 7 , 101, 1 0 1 , 113, 1 1 3 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Definition, D e f i n i t i o n , 27 2 7 VERSION, V E R S I O N , 49, 4 9 , 55, 5 5 , 59, 5 9 , 65, 6 5 , 95, 9 5 , 101 1 0 1 Definition, D e f i n i t i o n , 27 2 7 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . __________ _ _ _ _ _ _ _ _ _ _ granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . FINAL F I N A L VERSION V E R S I O N Medical M e d i c a l device d e v i c e software s o f t w a r e – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s IEC I E C 62304 6 2 3 0 4 Edition E d i t i o n 1.12015-06 1 . 1 2 0 1 5 - 0 6 colour c o l o u r inside i n s i d e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 2 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 CONTENTS C O N T E N T S FOREWORD......................................................................................................................................... F O R E W O R D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 INTRODUCTION.................................................................................................................................. I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 INTRODUCTION I N T R O D U C T I O N to t o Amendment A m e n d m e n t 1.....................................................................................................8 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 1 Scope.............................................................................................................................................. S c o p e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 1.1 1 . 1 * * Purpose............................................................................................................................. P u r p o s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 1.2 1 . 2 * * Field F i e l d of o f application...........................................................................................................9 a p p l i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.3 1 . 3 Relationship R e l a t i o n s h i p to t o other o t h e r standards........................................................................................9 s t a n d a r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.4 1 . 4 Compliance.......................................................................................................................... C o m p l i a n c e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 2 2 * * Normative N o r m a t i v e references...............................................................................................................10 r e f e r e n c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 3 3 * * Terms T e r m s and a n d definitions...............................................................................................................10 d e f i n i t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 4 4 * * General G e n e r a l requirements...............................................................................................................15 r e q u i r e m e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 4.1 4 . 1 * * Quality Q u a l i t y management m a n a g e m e n t system.........................................................................................15 s y s t e m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 4.2 4 . 2 * * RISK R I S K MANAGEMENT...........................................................................................................15 M A N A G E M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 4.3 4 . 3 * * Software S o f t w a r e safety s a f e t y classification........................................................................................16 c l a s s i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 4.4 4 . 4 * * LEGACY L E G A C Y SOFTWARE...........................................................................................................17 S O F T W A R E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS................................................................................................18 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8 5.1 5 . 1 * * Software S o f t w a r e development d e v e l o p m e n t planning...................................................................................18 p l a n n i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8 5.2 5 . 2 * * Software S o f t w a r e requirements r e q u i r e m e n t s analysis....................................................................................21 a n a l y s i s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 5.3 5 . 3 * * Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design...................................................................................22 d e s i g n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2 5.4 5 . 4 * * Software S o f t w a r e detailed d e t a i l e d design...............................................................................................23 d e s i g n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 5.5 5 . 5 * * SOFTWARE S O F T W A R E UNIT U N I T implementation....................................................................................24 i m p l e m e n t a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4 5.6 5 . 6 * * Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing...............................................................25 t e s t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 5.7 5 . 7 * * SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing..............................................................................................26 t e s t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6 5.8 5 . 8 * * Software S o f t w a r e release.............................................................................................................27 r e l e a s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 7 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS................................................................................................28 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 6.1 6 . 1 * * Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan..........................................................................28 p l a n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 6.2 6 . 2 * * Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis...............................................................................29 a n a l y s i s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9 6.3 6 . 3 * * Modification M o d i f i c a t i o n implementation..........................................................................................30 i m p l e m e n t a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 7 7 * * Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS.....................................................................................30 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 7.1 7 . 1 * * Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations........................................30 s i t u a t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures...................................................................................................31 m e a s u r e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures.......................................................................31 m e a s u r e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes..........................................................................31 c h a n g e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 8 8 * * Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS......................................................................32 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 8.1 8 . 1 * * Configuration C o n f i g u r a t i o n identification............................................................................................32 i d e n t i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 8.2 8 . 2 * * Change C h a n g e control...............................................................................................................32 c o n t r o l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 8.3 8 . 3 * * Configuration C o n f i g u r a t i o n status s t a t u s accounting...................................................................................33 a c c o u n t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 9 9 * * Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS...................................................................................33 P R O C E S S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS...............................................................................................33 R E P O R T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem....................................................................................................33 p r o b l e m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties.....................................................................................................33 p a r t i e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process............................................................................................34 p r o c e s s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9.5 9 . 5 Maintain M a i n t a i n records...............................................................................................................34 r e c o r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends............................................................................................34 t r e n d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution..................................................................................34 r e s o l u t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 3 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents...........................................................................................34 c o n t e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4 Annex A n n e x A A (informative) ( i n f o r m a t i v e ) Rationale R a t i o n a l e for f o r the t h e requirements r e q u i r e m e n t s of o f this t h i s standard......................................35 s t a n d a r d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 Annex A n n e x B B (informative) ( i n f o r m a t i v e ) Guidance G u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard...........................................38 s t a n d a r d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8 Annex A n n e x C C (informative) ( i n f o r m a t i v e ) Relationship R e l a t i o n s h i p to t o other o t h e r standards................................................................56 s t a n d a r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6 Annex A n n e x D D (informative) ( i n f o r m a t i v e ) Implementation...........................................................................................75 I m p l e m e n t a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5 Bibliography........................................................................................................................................ B i b l i o g r a p h y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 7 7 Index I n d e x of o f defined d e f i n e d terms....................................................................................................................... t e r m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 7 9 Figure F i g u r e 1 1 – – Overview O v e r v i e w of o f software s o f t w a r e development d e v e l o p m e n t PROCESSES P R O C E S S E S and a n d ACTIVITIES....................................7 A C T I V I T I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Figure F i g u r e 2 2 – – Overview O v e r v i e w of o f software s o f t w a r e maintenance m a i n t e n a n c e PROCESSES P R O C E S S E S and a n d ACTIVITIES....................................7 A C T I V I T I E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Figure F i g u r e 3 3 – – Assigning A s s i g n i n g software s o f t w a r e safety s a f e t y classification........................................................................16 c l a s s i f i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 Figure F i g u r e B.2 B . 2 – – Pictorial P i c t o r i a l representation r e p r e s e n t a t i o n of o f the t h e relationship r e l a t i o n s h i p of o f HAZARD, H A Z A R D , sequence s e q u e n c e of o f events, e v e n t s , HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , and a n d HARM H A R M – – from f r o m ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 Annex A n n e x E................................42 E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2 Figure F i g u r e B.1 B . 1 – – Example E x a m p l e of o f partitioning p a r t i t i o n i n g of o f SOFTWARE S O F T W A R E ITEMS..............................................................44 I T E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 Figure F i g u r e C.1 C . 1 – – Relationship R e l a t i o n s h i p of o f key k e y MEDICAL M E D I C A L DEVICE D E V I C E standards s t a n d a r d s to t o IEC I E C 62304.................................56 6 2 3 0 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6 Figure F i g u r e C.2 C . 2 – – Software S o f t w a r e as a s part p a r t of o f the t h e V-model................................................................................59 V - m o d e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 9 Figure F i g u r e C.3 C . 3 – – Application A p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1.............................................................67 6 1 0 1 0 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 7 Table T a b l e A.1 A . 1 – – Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y software s o f t w a r e safety s a f e t y class..................................................37 c l a s s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7 Table T a b l e B.1 B . 1 – – Development D e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d in i n ISO/IEC I S O / I E C 12207...............................39 1 2 2 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9 Table T a b l e C.1 C . 1 – – Relationship R e l a t i o n s h i p to t o ISO I S O 13485:2003.................................................................................57 1 3 4 8 5 : 2 0 0 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 7 Table T a b l e C.2 C . 2 – – Relationship R e l a t i o n s h i p to t o ISO I S O 14971:2007.................................................................................58 1 4 9 7 1 : 2 0 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 8 Table T a b l e C.3 C . 3 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-1........................................................................................61 6 0 6 0 1 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1 Table T a b l e C.5 C . 5 – – Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207....................................................................................69 1 2 2 0 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 9 Table T a b l e D.1 D . 1 – – Checklist C h e c k l i s t for f o r small s m a l l companies c o m p a n i e s without w i t h o u t a a certified c e r t i f i e d QMS............................................76 Q M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 4 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 INTERNATIONAL I N T E R N A T I O N A L ELECTROTECHNICAL E L E C T R O T E C H N I C A L COMMISSION C O M M I S S I O N MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E – – SOFTWARE S O F T W A R E LIFE L I F E CYCLE C Y C L E PROCESSES P R O C E S S E S FOREWORD F O R E W O R D The T h e International I n t e r n a t i o n a l Electrotechnical E l e c t r o t e c h n i c a l Commission C o m m i s s i o n (IEC) ( I E C ) is i s a a worldwide w o r l d w i d e organization o r g a n i z a t i o n for f o r standardization s t a n d a r d i z a t i o n comprising c o m p r i s i n g all a l l national n a t i o n a l electrotechnical e l e c t r o t e c h n i c a l committees c o m m i t t e e s (IEC ( I E C National N a t i o n a l Committees). C o m m i t t e e s ) . The T h e object o b j e c t of o f IEC I E C is i s to t o promote p r o m o t e international i n t e r n a t i o n a l co-operation c o - o p e r a t i o n on o n all a l l questions q u e s t i o n s concerning c o n c e r n i n g standardization s t a n d a r d i z a t i o n in i n the t h e electrical e l e c t r i c a l and a n d electronic e l e c t r o n i c fields. f i e l d s . To T o this t h i s end e n d and a n d in i n addition a d d i t i o n to t o other o t h e r activities, a c t i v i t i e s , IEC I E C publishes p u b l i s h e s International I n t e r n a t i o n a l Standards, S t a n d a r d s , Technical T e c h n i c a l Specifications, S p e c i f i c a t i o n s , Technical T e c h n i c a l Reports, R e p o r t s , Publicly P u b l i c l y Available A v a i l a b l e Specifications S p e c i f i c a t i o n s (PAS) ( P A S ) and a n d Guides G u i d e s (hereafter ( h e r e a f t e r referred r e f e r r e d to t o as a s “IEC “ I E C Publication(s)”). P u b l i c a t i o n ( s ) ” ) . Their T h e i r preparation p r e p a r a t i o n is i s entrusted e n t r u s t e d to t o technical t e c h n i c a l committees; c o m m i t t e e s ; any a n y IEC I E C National N a t i o n a l Committee C o m m i t t e e interested i n t e r e s t e d in i n the t h e subject s u b j e c t dealt d e a l t with w i t h may m a y participate p a r t i c i p a t e in i n this t h i s preparatory p r e p a r a t o r y work. w o r k . International, I n t e r n a t i o n a l , governmental g o v e r n m e n t a l and a n d non- n o n - governmental g o v e r n m e n t a l organizations o r g a n i z a t i o n s liaising l i a i s i n g with w i t h the t h e IEC I E C also a l s o participate p a r t i c i p a t e in i n this t h i s preparation. p r e p a r a t i o n . IEC I E C collaborates c o l l a b o r a t e s closely c l o s e l y with w i t h the t h e International I n t e r n a t i o n a l Organization O r g a n i z a t i o n for f o r Standardization S t a n d a r d i z a t i o n (ISO) ( I S O ) in i n accordance a c c o r d a n c e with w i t h conditions c o n d i t i o n s determined d e t e r m i n e d by b y agreement a g r e e m e n t between b e t w e e n the t h e two t w o organizations. o r g a n i z a t i o n s . The T h e formal f o r m a l decisions d e c i s i o n s or o r agreements a g r e e m e n t s of o f IEC I E C on o n technical t e c h n i c a l matters m a t t e r s express, e x p r e s s , as a s nearly n e a r l y as a s possible, p o s s i b l e , an a n international i n t e r n a t i o n a l consensus c o n s e n s u s of o f opinion o p i n i o n on o n the t h e relevant r e l e v a n t subjects s u b j e c t s since s i n c e each e a c h technical t e c h n i c a l committee c o m m i t t e e has h a s representation r e p r e s e n t a t i o n from f r o m all a l l interested i n t e r e s t e d IEC I E C National N a t i o n a l Committees. C o m m i t t e e s . IEC I E C Publications P u b l i c a t i o n s have h a v e the t h e form f o r m of o f recommendations r e c o m m e n d a t i o n s for f o r international i n t e r n a t i o n a l use u s e and a n d are a r e accepted a c c e p t e d by b y IEC I E C National N a t i o n a l Committees C o m m i t t e e s in i n that t h a t sense. s e n s e . While W h i l e all a l l reasonable r e a s o n a b l e efforts e f f o r t s are a r e made m a d e to t o ensure e n s u r e that t h a t the t h e technical t e c h n i c a l content c o n t e n t of o f IEC I E C Publications P u b l i c a t i o n s is i s accurate, a c c u r a t e , IEC I E C cannot c a n n o t be b e held h e l d responsible r e s p o n s i b l e for f o r the t h e way w a y in i n which w h i c h they t h e y are a r e used u s e d or o r for f o r any a n y misinterpretation m i s i n t e r p r e t a t i o n by b y any a n y end e n d user. u s e r . In I n order o r d e r to t o promote p r o m o t e international i n t e r n a t i o n a l uniformity, u n i f o r m i t y , IEC I E C National N a t i o n a l Committees C o m m i t t e e s undertake u n d e r t a k e to t o apply a p p l y IEC I E C Publications P u b l i c a t i o n s transparently t r a n s p a r e n t l y to t o the t h e maximum m a x i m u m extent e x t e n t possible p o s s i b l e in i n their t h e i r national n a t i o n a l and a n d regional r e g i o n a l publications. p u b l i c a t i o n s . Any A n y divergence d i v e r g e n c e between b e t w e e n any a n y IEC I E C Publication P u b l i c a t i o n and a n d the t h e corresponding c o r r e s p o n d i n g national n a t i o n a l or o r regional r e g i o n a l publication p u b l i c a t i o n shall s h a l l be b e clearly c l e a r l y indicated i n d i c a t e d in i n the t h e latter. l a t t e r . IEC I E C itself i t s e l f does d o e s not n o t provide p r o v i d e any a n y attestation a t t e s t a t i o n of o f conformity. c o n f o r m i t y . Independent I n d e p e n d e n t certification c e r t i f i c a t i o n bodies b o d i e s provide p r o v i d e conformity c o n f o r m i t y assessment a s s e s s m e n t services s e r v i c e s and, a n d , in i n some s o m e areas, a r e a s , access a c c e s s to t o IEC I E C marks m a r k s of o f conformity. c o n f o r m i t y . IEC I E C is i s not n o t responsible r e s p o n s i b l e for f o r any a n y services s e r v i c e s carried c a r r i e d out o u t by b y independent i n d e p e n d e n t certification c e r t i f i c a t i o n bodies. b o d i e s . All A l l users u s e r s should s h o u l d ensure e n s u r e that t h a t they t h e y have h a v e the t h e latest l a t e s t edition e d i t i o n of o f this t h i s publication. p u b l i c a t i o n . No N o liability l i a b i l i t y shall s h a l l attach a t t a c h to t o IEC I E C or o r its i t s directors, d i r e c t o r s , employees, e m p l o y e e s , servants s e r v a n t s or o r agents a g e n t s including i n c l u d i n g individual i n d i v i d u a l experts e x p e r t s and a n d members m e m b e r s of o f its i t s technical t e c h n i c a l committees c o m m i t t e e s and a n d IEC I E C National N a t i o n a l Committees C o m m i t t e e s for f o r any a n y personal p e r s o n a l injury, i n j u r y , property p r o p e r t y damage d a m a g e or o r other o t h e r damage d a m a g e of o f any a n y nature n a t u r e whatsoever, w h a t s o e v e r , whether w h e t h e r direct d i r e c t or o r indirect, i n d i r e c t , or o r for f o r costs c o s t s (including ( i n c l u d i n g legal l e g a l fees) f e e s ) and a n d expenses e x p e n s e s arising a r i s i n g out o u t of o f the t h e publication, p u b l i c a t i o n , use u s e of, o f , or o r reliance r e l i a n c e upon, u p o n , this t h i s IEC I E C Publication P u b l i c a t i o n or o r any a n y other o t h e r IEC I E C Publications. P u b l i c a t i o n s . Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e Normative N o r m a t i v e references r e f e r e n c e s cited c i t e d in i n this t h i s publication. p u b l i c a t i o n . Use U s e of o f the t h e referenced r e f e r e n c e d publications p u b l i c a t i o n s is i s indispensable i n d i s p e n s a b l e for f o r the t h e correct c o r r e c t application a p p l i c a t i o n of o f this t h i s publication. p u b l i c a t i o n . Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e possibility p o s s i b i l i t y that t h a t some s o m e of o f the t h e elements e l e m e n t s of o f this t h i s IEC I E C Publication P u b l i c a t i o n may m a y be b e the t h e subject s u b j e c t of o f patent p a t e n t rights. r i g h t s . IEC I E C shall s h a l l not n o t be b e held h e l d responsible r e s p o n s i b l e for f o r identifying i d e n t i f y i n g any a n y or o r all a l l such s u c h patent p a t e n t rights. r i g h t s . DISCLAIMER D I S C L A I M E R This T h i s Consolidated C o n s o l i d a t e d version v e r s i o n is i s not n o t an a n official o f f i c i a l IEC I E C Standard S t a n d a r d and a n d has h a s been b e e n prepared p r e p a r e d for f o r user u s e r convenience. c o n v e n i e n c e . Only O n l y the t h e current c u r r e n t versions v e r s i o n s of o f the t h e standard s t a n d a r d and a n d its i t s amendment(s) a m e n d m e n t ( s ) are a r e to t o be b e considered c o n s i d e r e d the t h e official o f f i c i a l documents. d o c u m e n t s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . This T h i s Consolidated C o n s o l i d a t e d version v e r s i o n of o f IEC I E C 62304 6 2 3 0 4 bears b e a r s the t h e edition e d i t i o n number n u m b e r 1.1. 1 . 1 . It I t consists c o n s i s t s of o f the t h e first f i r s t edition e d i t i o n (2006-05) ( 2 0 0 6 - 0 5 ) [documents [ d o c u m e n t s 62A/523/FDIS 6 2 A / 5 2 3 / F D I S and a n d 62A/528/RVD] 6 2 A / 5 2 8 / R V D ] and a n d its i t s amendment a m e n d m e n t 1 1 (2015-06) ( 2 0 1 5 - 0 6 ) [documents [ d o c u m e n t s 62A/1007/FDIS 6 2 A / 1 0 0 7 / F D I S and a n d 62A/1014/RVD]. 6 2 A / 1 0 1 4 / R V D ] . The T h e technical t e c h n i c a l content c o n t e n t is i s identical i d e n t i c a l to t o the t h e base b a s e edition e d i t i o n and a n d its i t s amendment. a m e n d m e n t . This T h i s Final F i n a l version v e r s i o n does d o e s not n o t show s h o w where w h e r e the t h e technical t e c h n i c a l content c o n t e n t is i s modified m o d i f i e d by b y amendment a m e n d m e n t 1. 1 . A A separate s e p a r a t e Redline R e d l i n e version v e r s i o n with w i t h all a l l changes c h a n g e s highlighted h i g h l i g h t e d is i s available a v a i l a b l e in i n this t h i s publication. p u b l i c a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 5 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 International I n t e r n a t i o n a l Standard S t a n d a r d IEC I E C 62304 6 2 3 0 4 has h a s been b e e n prepared p r e p a r e d by b y a a joint j o i n t working w o r k i n g group g r o u p of o f subcommittee s u b c o m m i t t e e 62A: 6 2 A : Common C o m m o n aspects a s p e c t s of o f electrical e l e c t r i c a l equipment e q u i p m e n t used u s e d in i n medical m e d i c a l practice, p r a c t i c e , of o f IEC I E C technical t e c h n i c a l committee c o m m i t t e e 62: 6 2 : Electrical E l e c t r i c a l equipment e q u i p m e n t in i n medical m e d i c a l practice p r a c t i c e and a n d ISO I S O Technical T e c h n i c a l Committee C o m m i t t e e 210, 2 1 0 , Quality Q u a l i t y management m a n a g e m e n t and a n d corresponding c o r r e s p o n d i n g general g e n e r a l aspects a s p e c t s for f o r MEDICAL M E D I C A L DEVICES. D E V I C E S . Table T a b l e C.5 C . 5 was w a s prepared p r e p a r e d by b y ISO/IEC I S O / I E C JTC J T C 1/SC 1 / S C 7, 7 , Software S o f t w a r e and a n d system s y s t e m engineering. e n g i n e e r i n g . It I t is i s published p u b l i s h e d as a s a a dual d u a l logo l o g o standard. s t a n d a r d . This T h i s publication p u b l i c a t i o n has h a s been b e e n drafted d r a f t e d in i n accordance a c c o r d a n c e with w i t h the t h e ISO/IEC I S O / I E C Directives, D i r e c t i v e s , Part P a r t 2. 2 . In I n this t h i s standard s t a n d a r d the t h e following f o l l o w i n g print p r i n t types t y p e s are a r e used: u s e d : requirements r e q u i r e m e n t s and a n d definitions: d e f i n i t i o n s : in i n roman r o m a n type; t y p e ; informative i n f o r m a t i v e material m a t e r i a l appearing a p p e a r i n g outside o u t s i d e of o f tables, t a b l e s , such s u c h as a s notes, n o t e s , examples e x a m p l e s and a n d references: r e f e r e n c e s : in i n smaller s m a l l e r type. t y p e . Normative N o r m a t i v e text t e x t of o f tables t a b l e s is i s also a l s o in i n a a smaller s m a l l e r type; t y p e ; terms t e r m s used u s e d throughout t h r o u g h o u t this t h i s standard s t a n d a r d that t h a t have h a v e been b e e n defined d e f i n e d in i n Clause C l a u s e 3 3 and a n d also a l s o given g i v e n in i n the t h e index: i n d e x : in i n small s m a l l capitals. c a p i t a l s . An A n asterisk a s t e r i s k (*) ( * ) as a s the t h e first f i r s t character c h a r a c t e r of o f a a title t i t l e or o r at a t the t h e beginning b e g i n n i n g of o f a a paragraph p a r a g r a p h indicates i n d i c a t e s that t h a t there t h e r e is i s guidance g u i d a n c e related r e l a t e d to t o that t h a t item i t e m in i n Annex A n n e x B. B . The T h e committee c o m m i t t e e has h a s decided d e c i d e d that t h a t the t h e contents c o n t e n t s of o f the t h e base b a s e publication p u b l i c a t i o n and a n d its i t s amendment a m e n d m e n t will w i l l remain r e m a i n unchanged u n c h a n g e d until u n t i l the t h e stability s t a b i l i t y date d a t e indicated i n d i c a t e d on o n the t h e IEC I E C web w e b site s i t e under u n d e r "http://webstore.iec.ch" " h t t p : / / w e b s t o r e . i e c . c h " in i n the t h e data d a t a related r e l a t e d to t o the t h e specific s p e c i f i c publication. p u b l i c a t i o n . At A t this t h i s date, d a t e , the t h e publication p u b l i c a t i o n will w i l l be b e � reconfirmed, r e c o n f i r m e d , � withdrawn, w i t h d r a w n , � replaced r e p l a c e d by b y a a revised r e v i s e d edition, e d i t i o n , or o r � amended. a m e n d e d . NOTE N O T E The T h e attention a t t e n t i o n of o f National N a t i o n a l Committees C o m m i t t e e s is i s drawn d r a w n to t o the t h e fact f a c t that t h a t equipment e q u i p m e n t MANUFACTURERS M A N U F A C T U R E R S and a n d testing t e s t i n g organizations o r g a n i z a t i o n s may m a y need n e e d a a transitional t r a n s i t i o n a l period p e r i o d following f o l l o w i n g publication p u b l i c a t i o n of o f a a new, n e w , amended a m e n d e d or o r revised r e v i s e d IEC I E C or o r ISO I S O publication p u b l i c a t i o n in i n which w h i c h to t o make m a k e products p r o d u c t s in i n accordance a c c o r d a n c e with w i t h the t h e new n e w requirements r e q u i r e m e n t s and a n d to t o equip e q u i p themselves t h e m s e l v e s for f o r conducting c o n d u c t i n g new n e w or o r revised r e v i s e d tests. t e s t s . It I t is i s the t h e recommendation r e c o m m e n d a t i o n of o f the t h e committee c o m m i t t e e that t h a t the t h e content c o n t e n t of o f this t h i s publication p u b l i c a t i o n be b e adopted a d o p t e d for f o r mandatory m a n d a t o r y implementation i m p l e m e n t a t i o n nationally n a t i o n a l l y not n o t earlier e a r l i e r than t h a n 3 3 years y e a r s from f r o m the t h e date d a t e of o f publication. p u b l i c a t i o n . IMPORTANT I M P O R T A N T – – The T h e 'colour ' c o l o u r inside' i n s i d e ' logo l o g o on o n the t h e cover c o v e r page p a g e of o f this t h i s publication p u b l i c a t i o n indicates i n d i c a t e s that t h a t it i t contains c o n t a i n s colours c o l o u r s which w h i c h are a r e considered c o n s i d e r e d to t o be b e useful u s e f u l for f o r the t h e correct c o r r e c t understanding u n d e r s t a n d i n g of o f its i t s contents. c o n t e n t s . Users U s e r s should s h o u l d therefore t h e r e f o r e print p r i n t this t h i s document d o c u m e n t using u s i n g a a colour c o l o u r printer. p r i n t e r . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 6 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 INTRODUCTION I N T R O D U C T I O N Software S o f t w a r e is i s often o f t e n an a n integral i n t e g r a l part p a r t of o f MEDICAL M E D I C A L DEVICE D E V I C E technology. t e c h n o l o g y . Establishing E s t a b l i s h i n g the t h e SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s of o f a a MEDICAL M E D I C A L DEVICE D E V I C E containing c o n t a i n i n g software s o f t w a r e requires r e q u i r e s knowledge k n o w l e d g e of o f what w h a t the t h e software s o f t w a r e is i s intended i n t e n d e d to t o do d o and a n d demonstration d e m o n s t r a t i o n that t h a t the t h e use u s e of o f the t h e software s o f t w a r e fulfils f u l f i l s those t h o s e intentions i n t e n t i o n s without w i t h o u t causing c a u s i n g any a n y unacceptable u n a c c e p t a b l e RISKS. R I S K S . This T h i s standard s t a n d a r d provides p r o v i d e s a a framework f r a m e w o r k of o f life l i f e cycle c y c l e PROCESSES P R O C E S S E S with w i t h ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S necessary n e c e s s a r y for f o r the t h e safe s a f e design d e s i g n and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s standard s t a n d a r d provides p r o v i d e s requirements r e q u i r e m e n t s for f o r each e a c h life l i f e cycle c y c l e PROCESS. P R O C E S S . Each E a c h life l i f e cycle c y c l e PROCESS P R O C E S S consists c o n s i s t s of o f a a set s e t of o f ACTIVITIES, A C T I V I T I E S , with w i t h most m o s t ACTIVITIES A C T I V I T I E S consisting c o n s i s t i n g of o f a a set s e t of o f TASKS. T A S K S . As A s a a basic b a s i c foundation f o u n d a t i o n it i t is i s assumed a s s u m e d that t h a t MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s developed d e v e l o p e d and a n d maintained m a i n t a i n e d within w i t h i n a a quality q u a l i t y management m a n a g e m e n t system s y s t e m (see ( s e e 4.1) 4 . 1 ) and a n d a a RISK R I S K MANAGEMENT M A N A G E M E N T system s y s t e m (see ( s e e 4.2). 4 . 2 ) . The T h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S is i s already a l r e a d y very v e r y well w e l l addressed a d d r e s s e d by b y the t h e International I n t e r n a t i o n a l Standard S t a n d a r d ISO I S O 14971. 1 4 9 7 1 . Therefore T h e r e f o r e IEC I E C 62304 6 2 3 0 4 makes m a k e s use u s e of o f this t h i s advantage a d v a n t a g e simply s i m p l y by b y a a normative n o r m a t i v e reference r e f e r e n c e to t o ISO I S O 14971. 1 4 9 7 1 . Some S o m e minor m i n o r additional a d d i t i o n a l RISK R I S K MANAGEMENT M A N A G E M E N T requirements r e q u i r e m e n t s are a r e needed n e e d e d for f o r software, s o f t w a r e , especially e s p e c i a l l y in i n the t h e area a r e a of o f identification i d e n t i f i c a t i o n of o f contributing c o n t r i b u t i n g software s o f t w a r e factors f a c t o r s related r e l a t e d to t o HAZARDS. H A Z A R D S . These T h e s e requirements r e q u i r e m e n t s are a r e summarized s u m m a r i z e d and a n d captured c a p t u r e d in i n Clause C l a u s e 7 7 as a s the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . Whether W h e t h e r software s o f t w a r e is i s a a contributing c o n t r i b u t i n g factor f a c t o r to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N is i s determined d e t e r m i n e d during d u r i n g the t h e HAZARD H A Z A R D identification i d e n t i f i c a t i o n ACTIVITY A C T I V I T Y of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t could c o u l d be b e indirectly i n d i r e c t l y caused c a u s e d by b y software s o f t w a r e (for ( f o r example, e x a m p l e , by b y providing p r o v i d i n g misleading m i s l e a d i n g information i n f o r m a t i o n that t h a t could c o u l d cause c a u s e inappropriate i n a p p r o p r i a t e treatment t r e a t m e n t to t o be b e administered) a d m i n i s t e r e d ) need n e e d to t o be b e considered c o n s i d e r e d when w h e n determining d e t e r m i n i n g whether w h e t h e r software s o f t w a r e is i s a a contributing c o n t r i b u t i n g factor. f a c t o r . The T h e decision d e c i s i o n to t o use u s e software s o f t w a r e to t o control c o n t r o l RISK R I S K is i s made m a d e during d u r i n g the t h e RISK R I S K CONTROL C O N T R O L ACTIVITY A C T I V I T Y of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S required r e q u i r e d in i n this t h i s standard s t a n d a r d has h a s to t o be b e embedded e m b e d d e d in i n the t h e device d e v i c e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S according a c c o r d i n g to t o ISO I S O 14971. 1 4 9 7 1 . The T h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S consists c o n s i s t s of o f a a number n u m b e r of o f ACTIVITIES. A C T I V I T I E S . These T h e s e ACTIVITIES A C T I V I T I E S are a r e shown s h o w n in i n Figure F i g u r e 1 1 and a n d described d e s c r i b e d in i n Clause C l a u s e 5. 5 . Because B e c a u s e many m a n y incidents i n c i d e n t s in i n the t h e field f i e l d are a r e related r e l a t e d to t o service s e r v i c e or o r maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SYSTEMS S Y S T E M S including i n c l u d i n g inappropriate i n a p p r o p r i a t e software s o f t w a r e updates u p d a t e s and a n d upgrades, u p g r a d e s , the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s considered c o n s i d e r e d to t o be b e as a s important i m p o r t a n t as a s the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS. P R O C E S S . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s very v e r y similar s i m i l a r to t o the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS. P R O C E S S . It I t is i s shown s h o w n in i n Figure F i g u r e 2 2 and a n d described d e s c r i b e d in i n Clause C l a u s e 6. 6 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 7 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Activities A c t i v i t i e s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard s t a n d a r d Customer C u s t o m e r needs n e e d s Customer C u s t o m e r needs n e e d s satisfied s a t i s f i e d SYSTEM S Y S T E M development d e v e l o p m e n t ACTIVITIES A C T I V I T I E S (including ( i n c l u d i n g RISK R I S K MANAGEMENT) M A N A G E M E N T ) 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T 5.1 5 . 1 5.2 5 . 2 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.4 5 . 4 5.5 5 . 5 5.6 5 . 6 Software S o f t w a r e Software S o f t w a r e detailed d e t a i l e d UNIT U N I T design d e s i g n implementation i m p l e m e n t a t i o n Software S o f t w a r e and a n d VERIFICATION V E R I F I C A T I O N integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 Software S o f t w a r e SYSTEM S Y S T E M testing t e s t i n g 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n IEC I E C 722/06 7 2 2 / 0 6 Figure F i g u r e 1 1 – – Overview O v e r v i e w of o f software s o f t w a r e development d e v e l o p m e n t PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S Maintenance M a i n t e n a n c e request r e q u e s t Activities A c t i v i t i e s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard s t a n d a r d Request R e q u e s t satisfied s a t i s f i e d System S y s t e m maintenance m a i n t e n a n c e ACTIVITIES A C T I V I T I E S (including ( i n c l u d i n g RISK R I S K MANAGEMENT) M A N A G E M E N T ) 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T 5.3 5 . 3 6.1 6 . 1 6.2 6 . 2 Software S o f t w a r e Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysisARCHITECTURAL a n a l y s i s A R C H I T E C T U R A L plan p l a n design d e s i g n 5.4 5 . 4 5.5 5 . 5 5.6 5 . 6 Software S o f t w a r e detailed d e t a i l e d design d e s i g n Software S o f t w a r e UNIT U N I T Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 Software S o f t w a r e SYSTEM S Y S T E M implementation i m p l e m e n t a t i o n and a n d VERIFICATION V E R I F I C A T I O N testing t e s t i n g 5.8 5 . 8 Software S o f t w a r e release r e l e a s e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n IEC I E C 723/06 7 2 3 / 0 6 Figure F i g u r e 2 2 – – Overview O v e r v i e w of o f software s o f t w a r e maintenance m a i n t e n a n c e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S This T h i s standard s t a n d a r d identifies i d e n t i f i e s two t w o additional a d d i t i o n a l PROCESSES P R O C E S S E S considered c o n s i d e r e d essential e s s e n t i a l for f o r developing d e v e l o p i n g safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . They T h e y are a r e the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) and a n d the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S (Clause ( C l a u s e 9). 9 ) . Amendment A m e n d m e n t 1 1 updates u p d a t e s the t h e standard s t a n d a r d to t o add a d d requirements r e q u i r e m e n t s to t o deal d e a l with w i t h LEGACY L E G A C Y SOFTWARE, S O F T W A R E , where w h e r e the t h e software s o f t w a r e design d e s i g n is i s prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version, v e r s i o n , to t o assist a s s i s t manufacturers m a n u f a c t u r e r s who w h o must m u s t show s h o w compliance c o m p l i a n c e to t o the t h e standard s t a n d a r d to t o meet m e e t European E u r o p e a n Directives. D i r e c t i v e s . Software S o f t w a r e safety s a f e t y granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 8 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 classification c l a s s i f i c a t i o n changes c h a n g e s include i n c l u d e clarification c l a r i f i c a t i o n of o f requirements r e q u i r e m e n t s and a n d updating u p d a t i n g of o f the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o include i n c l u d e a a risk-based r i s k - b a s e d approach. a p p r o a c h . This T h i s standard s t a n d a r d does d o e s not n o t specify s p e c i f y an a n organizational o r g a n i z a t i o n a l structure s t r u c t u r e for f o r the t h e MANUFACTURER M A N U F A C T U R E R or o r which w h i c h part p a r t of o f the t h e organization o r g a n i z a t i o n is i s to t o perform p e r f o r m which w h i c h PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , or o r TASK. T A S K . This T h i s standard s t a n d a r d requires r e q u i r e s only o n l y that t h a t the t h e PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , or o r TASK T A S K be b e completed c o m p l e t e d to t o establish e s t a b l i s h compliance c o m p l i a n c e with w i t h this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t prescribe p r e s c r i b e the t h e name, n a m e , format, f o r m a t , or o r explicit e x p l i c i t content c o n t e n t of o f the t h e documentation d o c u m e n t a t i o n to t o be b e produced. p r o d u c e d . This T h i s standard s t a n d a r d requires r e q u i r e s documentation d o c u m e n t a t i o n of o f TASKS, T A S K S , but b u t the t h e decision d e c i s i o n of o f how h o w to t o package p a c k a g e this t h i s documentation d o c u m e n t a t i o n is i s left l e f t to t o the t h e user u s e r of o f the t h e standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t prescribe p r e s c r i b e a a specific s p e c i f i c life l i f e cycle c y c l e model. m o d e l . The T h e users u s e r s of o f this t h i s standard s t a n d a r d are a r e responsible r e s p o n s i b l e for f o r selecting s e l e c t i n g a a life l i f e cycle c y c l e model m o d e l for f o r the t h e software s o f t w a r e project p r o j e c t and a n d for f o r mapping m a p p i n g the t h e PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S in i n this t h i s standard s t a n d a r d onto o n t o that t h a t model. m o d e l . Annex A n n e x A A provides p r o v i d e s rationale r a t i o n a l e for f o r the t h e clauses c l a u s e s of o f this t h i s standard. s t a n d a r d . Annex A n n e x B B provides p r o v i d e s guidance g u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard. s t a n d a r d . For F o r the t h e purposes p u r p o s e s of o f this t h i s standard: s t a n d a r d : “shall” “ s h a l l ” means m e a n s that t h a t compliance c o m p l i a n c e with w i t h a a requirement r e q u i r e m e n t is i s mandatory m a n d a t o r y for f o r compliance c o m p l i a n c e with w i t h this t h i s standard; s t a n d a r d ; “should” “ s h o u l d ” means m e a n s that t h a t compliance c o m p l i a n c e with w i t h a a requirement r e q u i r e m e n t is i s recommended r e c o m m e n d e d but b u t is i s not n o t mandatory m a n d a t o r y for f o r compliance c o m p l i a n c e with w i t h this t h i s standard; s t a n d a r d ; “may” “ m a y ” is i s used u s e d to t o describe d e s c r i b e a a permissible p e r m i s s i b l e way w a y to t o achieve a c h i e v e compliance c o m p l i a n c e with w i t h a a requirement; r e q u i r e m e n t ; “establish” “ e s t a b l i s h ” means m e a n s to t o define, d e f i n e , document, d o c u m e n t , and a n d implement; i m p l e m e n t ; and a n d � where w h e r e this t h i s standard s t a n d a r d uses u s e s the t h e term t e r m “as “ a s appropriate” a p p r o p r i a t e ” in i n conjunction c o n j u n c t i o n with w i t h a a required r e q u i r e d PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , TASK T A S K or o r output, o u t p u t , the t h e intention i n t e n t i o n is i s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e PROCESS, P R O C E S S , ACTIVITY, A C T I V I T Y , TASK T A S K or o r output o u t p u t unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R can c a n document d o c u m e n t a a justification j u s t i f i c a t i o n for f o r not n o t so s o doing. d o i n g . INTRODUCTION I N T R O D U C T I O N to t o Amendment A m e n d m e n t 1 1 The T h e first f i r s t edition e d i t i o n of o f IEC I E C 62304 6 2 3 0 4 was w a s published p u b l i s h e d in i n 2006. 2 0 0 6 . This T h i s amendment a m e n d m e n t is i s intended i n t e n d e d to t o add a d d requirements r e q u i r e m e n t s to t o deal d e a l with w i t h LEGACY L E G A C Y SOFTWARE, S O F T W A R E , where w h e r e the t h e software s o f t w a r e design d e s i g n is i s prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version, v e r s i o n , to t o assist a s s i s t manufacturers m a n u f a c t u r e r s who w h o must m u s t show s h o w compliance c o m p l i a n c e to t o the t h e standard s t a n d a r d to t o meet m e e t European E u r o p e a n Directives. D i r e c t i v e s . Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n changes c h a n g e s needed n e e d e d for f o r this t h i s amendment a m e n d m e n t include i n c l u d e clarification c l a r i f i c a t i o n of o f requirements r e q u i r e m e n t s and a n d updating u p d a t i n g of o f the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o include i n c l u d e a a risk-based r i s k - b a s e d approach. a p p r o a c h . Work W o r k is i s continuing c o n t i n u i n g in i n parallel p a r a l l e l to t o develop d e v e l o p the t h e second s e c o n d edition e d i t i o n of o f IEC I E C 62304. 6 2 3 0 4 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 9 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E – – SOFTWARE S O F T W A R E LIFE L I F E CYCLE C Y C L E PROCESSES P R O C E S S E S 1 1 Scope S c o p e 1.1 1 . 1 * * Purpose P u r p o s e This T h i s standard s t a n d a r d defines d e f i n e s the t h e life l i f e cycle c y c l e requirements r e q u i r e m e n t s for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . The T h e set s e t of o f PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S described d e s c r i b e d in i n this t h i s standard s t a n d a r d establishes e s t a b l i s h e s a a common c o m m o n framework f r a m e w o r k for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E life l i f e cycle c y c l e PROCESSES. P R O C E S S E S . 1.2 1 . 2 * * Field F i e l d of o f application a p p l i c a t i o n This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E when w h e n software s o f t w a r e is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE D E V I C E or o r when w h e n software s o f t w a r e is i s an a n embedded e m b e d d e d or o r integral i n t e g r a l part p a r t of o f the t h e final f i n a l MEDICAL M E D I C A L DEVICE. D E V I C E . NOTE N O T E 1 1 This T h i s standard s t a n d a r d can c a n be b e used u s e d in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f software s o f t w a r e that t h a t is i s itself i t s e l f a a medical m e d i c a l device. d e v i c e . However, H o w e v e r , additional a d d i t i o n a l development d e v e l o p m e n t activities a c t i v i t i e s are a r e needed n e e d e d at a t the t h e system s y s t e m level l e v e l before b e f o r e this t h i s type t y p e of o f software s o f t w a r e can c a n be b e placed p l a c e d into i n t o service. s e r v i c e . These T h e s e system s y s t e m activities a c t i v i t i e s are a r e not n o t covered c o v e r e d by b y this t h i s standard, s t a n d a r d , but b u t can c a n be b e found f o u n d in i n IEC I E C 82304-1 8 2 3 0 4 - 1 1 1 [22]. [ 2 2 ] . This T h i s standard s t a n d a r d describes d e s c r i b e s PROCESSES P R O C E S S E S that t h a t are a r e intended i n t e n d e d to t o be b e applied a p p l i e d to t o software s o f t w a r e which w h i c h executes e x e c u t e s on o n a a processor p r o c e s s o r or o r which w h i c h is i s executed e x e c u t e d by b y other o t h e r software s o f t w a r e (for ( f o r example e x a m p l e an a n interpreter) i n t e r p r e t e r ) which w h i c h executes e x e c u t e s on o n a a processor. p r o c e s s o r . This T h i s standard s t a n d a r d applies a p p l i e s regardless r e g a r d l e s s of o f the t h e persistent p e r s i s t e n t storage s t o r a g e device(s) d e v i c e ( s ) used u s e d to t o store s t o r e the t h e software s o f t w a r e (for ( f o r example: e x a m p l e : hard h a r d disk, d i s k , optical o p t i c a l disk, d i s k , permanent p e r m a n e n t or o r flash f l a s h memory). m e m o r y ) . This T h i s standard s t a n d a r d applies a p p l i e s regardless r e g a r d l e s s of o f the t h e method m e t h o d of o f delivery d e l i v e r y of o f the t h e software s o f t w a r e (for ( f o r example: e x a m p l e : transmission t r a n s m i s s i o n by b y network n e t w o r k or o r email, e m a i l , optical o p t i c a l disk, d i s k , flash f l a s h memory m e m o r y or o r EEPROM). E E P R O M ) . The T h e method m e t h o d of o f software s o f t w a r e delivery d e l i v e r y itself i t s e l f is i s not n o t considered c o n s i d e r e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r validation v a l i d a t i o n and a n d final f i n a l release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE, D E V I C E , even e v e n when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E consists c o n s i s t s entirely e n t i r e l y of o f software. s o f t w a r e . NOTE N O T E 2 2 If I f a a medical m e d i c a l device d e v i c e incorporates i n c o r p o r a t e s embedded e m b e d d e d software s o f t w a r e intended i n t e n d e d to t o be b e executed e x e c u t e d on o n a a processor, p r o c e s s o r , the t h e requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d apply a p p l y to t o the t h e software, s o f t w a r e , including i n c l u d i n g the t h e requirements r e q u i r e m e n t s concerning c o n c e r n i n g software s o f t w a r e of o f unknown u n k n o w n provenance p r o v e n a n c e (see ( s e e 8.1.2). 8 . 1 . 2 ) . NOTE N O T E 3 3 Validation V a l i d a t i o n and a n d other o t h e r development d e v e l o p m e n t activities a c t i v i t i e s are a r e needed n e e d e d at a t the t h e system s y s t e m level l e v e l before b e f o r e the t h e software s o f t w a r e and a n d medical m e d i c a l device d e v i c e can c a n be b e placed p l a c e d into i n t o service. s e r v i c e . These T h e s e system s y s t e m activities a c t i v i t i e s are a r e not n o t covered c o v e r e d by b y this t h i s standard, s t a n d a r d , but b u t can c a n be b e found f o u n d in i n related r e l a t e d product p r o d u c t standards s t a n d a r d s (e.g., ( e . g . , IEC I E C 60601-1, 6 0 6 0 1 - 1 , IEC I E C 82304-1, 8 2 3 0 4 - 1 , etc.). e t c . ) . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 1.3 1 . 3 Relationship R e l a t i o n s h i p to t o other o t h e r standards s t a n d a r d s This T h i s MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E life l i f e cycle c y c l e standard s t a n d a r d is i s to t o be b e used u s e d together t o g e t h e r with w i t h other o t h e r appropriate a p p r o p r i a t e standards s t a n d a r d s when w h e n developing d e v e l o p i n g a a MEDICAL M E D I C A L DEVICE. D E V I C E . Annex A n n e x C C shows s h o w s the t h e relationship r e l a t i o n s h i p between b e t w e e n this t h i s standard s t a n d a r d and a n d other o t h e r relevant r e l e v a n t standards. s t a n d a r d s . 1.4 1 . 4 Compliance C o m p l i a n c e Compliance C o m p l i a n c e with w i t h this t h i s standard s t a n d a r d is i s defined d e f i n e d as a s implementing i m p l e m e n t i n g all a l l of o f the t h e PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S identified i d e n t i f i e d in i n this t h i s standard s t a n d a r d in i n accordance a c c o r d a n c e with w i t h the t h e software s o f t w a r e safety s a f e t y class. c l a s s . NOTE N O T E The T h e software s o f t w a r e safety s a f e t y classes c l a s s e s assigned a s s i g n e d to t o each e a c h requirement r e q u i r e m e n t are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t following f o l l o w i n g the t h e requirement. r e q u i r e m e n t . 1 1 In I n preparation. p r e p a r a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 10 1 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Compliance C o m p l i a n c e is i s determined d e t e r m i n e d by b y inspection i n s p e c t i o n of o f all a l l documentation d o c u m e n t a t i o n required r e q u i r e d by b y this t h i s standard s t a n d a r d including i n c l u d i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE, F I L E , and a n d assessment a s s e s s m e n t of o f the t h e PROCESSES, P R O C E S S E S , ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S required r e q u i r e d for f o r the t h e software s o f t w a r e safety s a f e t y class. c l a s s . NOTE N O T E 1 1 This T h i s assessment a s s e s s m e n t could c o u l d be b e carried c a r r i e d out o u t by b y internal i n t e r n a l or o r external e x t e r n a l audit. a u d i t . NOTE N O T E 2 2 Although A l t h o u g h the t h e specified s p e c i f i e d PROCESSES, P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , and a n d TASKS T A S K S are a r e performed, p e r f o r m e d , flexibility f l e x i b i l i t y exists e x i s t s in i n the t h e methods m e t h o d s of o f implementing i m p l e m e n t i n g these t h e s e PROCESSES P R O C E S S E S and a n d performing p e r f o r m i n g these t h e s e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . NOTE N O T E 3 3 Where W h e r e any a n y requirements r e q u i r e m e n t s contain c o n t a i n “as “ a s appropriate” a p p r o p r i a t e ” and a n d were w e r e not n o t performed, p e r f o r m e d , documentation d o c u m e n t a t i o n for f o r the t h e justification j u s t i f i c a t i o n is i s necessary n e c e s s a r y for f o r this t h i s assessment. a s s e s s m e n t . NOTE N O T E 4 4 The T h e term t e r m “conformance” “ c o n f o r m a n c e ” is i s used u s e d in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 where w h e r e the t h e term t e r m “compliance” “ c o m p l i a n c e ” is i s used u s e d in i n this t h i s standard. s t a n d a r d . NOTE N O T E 5 5 For F o r compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E see s e e 4.4. 4 . 4 . 2 2 * * Normative N o r m a t i v e references r e f e r e n c e s The T h e following f o l l o w i n g referenced r e f e r e n c e d documents d o c u m e n t s are a r e indispensable i n d i s p e n s a b l e for f o r the t h e application a p p l i c a t i o n of o f this t h i s document. d o c u m e n t . For F o r dated d a t e d references, r e f e r e n c e s , only o n l y the t h e edition e d i t i o n cited c i t e d applies. a p p l i e s . For F o r undated u n d a t e d references, r e f e r e n c e s , the t h e latest l a t e s t edition e d i t i o n of o f the t h e referenced r e f e r e n c e d document d o c u m e n t (including ( i n c l u d i n g any a n y amendments) a m e n d m e n t s ) applies. a p p l i e s . ISO I S O 14971, 1 4 9 7 1 , Medical M e d i c a l devices d e v i c e s – – Application A p p l i c a t i o n of o f risk r i s k management m a n a g e m e n t to t o medical m e d i c a l devices. d e v i c e s . 3 3 * * Terms T e r m s and a n d definitions d e f i n i t i o n s For F o r the t h e purposes p u r p o s e s of o f this t h i s document, d o c u m e n t , the t h e following f o l l o w i n g terms t e r m s and a n d definitions d e f i n i t i o n s apply. a p p l y . 3.1 3 . 1 ACTIVITY A C T I V I T Y a a set s e t of o f one o n e or o r more m o r e interrelated i n t e r r e l a t e d or o r interacting i n t e r a c t i n g TASKS T A S K S 3.2 3 . 2 ANOMALY A N O M A L Y any a n y condition c o n d i t i o n that t h a t deviates d e v i a t e s from f r o m the t h e expected e x p e c t e d based b a s e d on o n requirements r e q u i r e m e n t s specifications, s p e c i f i c a t i o n s , design d e s i g n documents, d o c u m e n t s , standards, s t a n d a r d s , etc. e t c . or o r from f r o m someone’s s o m e o n e ’ s perceptions p e r c e p t i o n s or o r experiences. e x p e r i e n c e s . ANOMALIES A N O M A L I E S may m a y be b e found f o u n d during, d u r i n g , but b u t not n o t limited l i m i t e d to, t o , the t h e review, r e v i e w , test, t e s t , analysis, a n a l y s i s , compilation, c o m p i l a t i o n , or o r use u s e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E or o r applicable a p p l i c a b l e documentation d o c u m e n t a t i o n NOTE N O T E Based B a s e d on o n IEEE I E E E 1044:1993, 1 0 4 4 : 1 9 9 3 , definition d e f i n i t i o n 3.1. 3 . 1 . 3.3 3 . 3 ARCHITECTURE A R C H I T E C T U R E organizational o r g a n i z a t i o n a l structure s t r u c t u r e of o f a a SYSTEM S Y S T E M or o r component c o m p o n e n t [IEEE [ I E E E 610.12:1990] 6 1 0 . 1 2 : 1 9 9 0 ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 3.4 3 . 4 CHANGE C H A N G E REQUEST R E Q U E S T a a documented d o c u m e n t e d specification s p e c i f i c a t i o n of o f a a change c h a n g e to t o be b e made m a d e to t o a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E 3.5 3 . 5 CONFIGURATION C O N F I G U R A T I O N ITEM I T E M entity e n t i t y that t h a t can c a n be b e uniquely u n i q u e l y identified i d e n t i f i e d at a t a a given g i v e n reference r e f e r e n c e point p o i n t NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4,7. 4 , 7 . 3.6 3 . 6 DELIVERABLE D E L I V E R A B L E required r e q u i r e d result r e s u l t or o r output o u t p u t (includes ( i n c l u d e s documentation) d o c u m e n t a t i o n ) of o f an a n ACTIVITY A C T I V I T Y or o r TASK T A S K granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 11 1 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.7 3 . 7 EVALUATION E V A L U A T I O N a a systematic s y s t e m a t i c determination d e t e r m i n a t i o n of o f the t h e extent e x t e n t to t o which w h i c h an a n entity e n t i t y meets m e e t s its i t s specified s p e c i f i e d criteria c r i t e r i a [ISO/IEC [ I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4.12] 4 . 1 2 ] 3.8 3 . 8 HARM H A R M physical p h y s i c a l injury, i n j u r y , damage, d a m a g e , or o r both b o t h to t o the t h e health h e a l t h of o f people p e o p l e or o r damage d a m a g e to t o property p r o p e r t y or o r the t h e environment e n v i r o n m e n t [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.2] 2 . 2 ] 3.9 3 . 9 HAZARD H A Z A R D potential p o t e n t i a l source s o u r c e of o f HARM H A R M [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.3] 2 . 3 ] 3.10 3 . 1 0 MANUFACTURER M A N U F A C T U R E R natural n a t u r a l or o r legal l e g a l person p e r s o n with w i t h responsibility r e s p o n s i b i l i t y for f o r designing, d e s i g n i n g , manufacturing, m a n u f a c t u r i n g , packaging, p a c k a g i n g , or o r labelling l a b e l l i n g a a MEDICAL M E D I C A L DEVICE; D E V I C E ; assembling a s s e m b l i n g a a SYSTEM; S Y S T E M ; or o r adapting a d a p t i n g a a MEDICAL M E D I C A L DEVICE D E V I C E before b e f o r e it i t is i s placed p l a c e d on o n the t h e market m a r k e t and/or a n d / o r put p u t into i n t o service, s e r v i c e , regardless r e g a r d l e s s of o f whether w h e t h e r these t h e s e operations o p e r a t i o n s are a r e carried c a r r i e d out o u t by b y that t h a t person p e r s o n or o r by b y a a third t h i r d party p a r t y on o n that t h a t person’s p e r s o n ’ s behalf b e h a l f NOTE N O T E 1 1 Attention A t t e n t i o n is i s drawn d r a w n to t o the t h e fact f a c t that t h a t the t h e provisions p r o v i s i o n s of o f national n a t i o n a l or o r regional r e g i o n a l regulations r e g u l a t i o n s can c a n apply a p p l y to t o the t h e definition d e f i n i t i o n of o f manufacturer. m a n u f a c t u r e r . NOTE N O T E 2 2 For F o r a a definition d e f i n i t i o n of o f labelling, l a b e l l i n g , see s e e ISO I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , definition d e f i n i t i o n 3.6. 3 . 6 . [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2,8] 2 , 8 ] 3.11 3 . 1 1 MEDICAL M E D I C A L DEVICE D E V I C E any a n y instrument, i n s t r u m e n t , apparatus, a p p a r a t u s , implement, i m p l e m e n t , machine, m a c h i n e , appliance, a p p l i a n c e , implant, i m p l a n t , in i n vitro v i t r o reagent r e a g e n t or o r calibrator, c a l i b r a t o r , software, s o f t w a r e , material m a t e r i a l or o r other o t h e r similar s i m i l a r or o r related r e l a t e d article, a r t i c l e , intended i n t e n d e d by b y the t h e MANUFACTURER M A N U F A C T U R E R to t o be b e used, u s e d , alone a l o n e or o r in i n combination, c o m b i n a t i o n , for f o r human h u m a n beings b e i n g s for f o r one o n e or o r more m o r e of o f the t h e specific s p e c i f i c purpose(s) p u r p o s e ( s ) of o f – – diagnosis, d i a g n o s i s , prevention, p r e v e n t i o n , monitoring, m o n i t o r i n g , treatment t r e a t m e n t or o r alleviation a l l e v i a t i o n of o f disease, d i s e a s e , – – diagnosis, d i a g n o s i s , monitoring, m o n i t o r i n g , treatment, t r e a t m e n t , alleviation a l l e v i a t i o n of o f or o r compensation c o m p e n s a t i o n for f o r an a n injury, i n j u r y , – – investigation, i n v e s t i g a t i o n , replacement, r e p l a c e m e n t , modification, m o d i f i c a t i o n , or o r support s u p p o r t of o f the t h e anatomy a n a t o m y or o r of o f a a physiological p h y s i o l o g i c a l PROCESS, P R O C E S S , – – supporting s u p p o r t i n g or o r sustaining s u s t a i n i n g life, l i f e , – – control c o n t r o l of o f conception, c o n c e p t i o n , – – disinfection d i s i n f e c t i o n of o f MEDICAL M E D I C A L DEVICES, D E V I C E S , – – providing p r o v i d i n g information i n f o r m a t i o n for f o r medical m e d i c a l purposes p u r p o s e s by b y means m e a n s of o f in i n vitro v i t r o examination e x a m i n a t i o n of o f specimens s p e c i m e n s derived d e r i v e d from f r o m the t h e human h u m a n body, b o d y , and a n d which w h i c h does d o e s not n o t achieve a c h i e v e its i t s primary p r i m a r y intended i n t e n d e d action a c t i o n in i n or o r on o n the t h e human h u m a n body b o d y by b y pharmacological, p h a r m a c o l o g i c a l , immunological i m m u n o l o g i c a l or o r metabolic m e t a b o l i c means, m e a n s , but b u t which w h i c h may m a y be b e assisted a s s i s t e d in i n its i t s function f u n c t i o n by b y such s u c h means m e a n s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E 1 1 This T h i s definition d e f i n i t i o n has h a s been b e e n developed d e v e l o p e d by b y the t h e Global G l o b a l Harmonization H a r m o n i z a t i o n Task T a s k Force F o r c e (GHTF). ( G H T F ) . See S e e bibliographic b i b l i o g r a p h i c reference r e f e r e n c e [15] [ 1 5 ] (in ( i n ISO I S O 13485:2003). 1 3 4 8 5 : 2 0 0 3 ) . [ISO [ I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , definition d e f i n i t i o n 3.7] 3 . 7 ] NOTE N O T E 2 2 Some S o m e differences d i f f e r e n c e s can c a n occur o c c u r in i n the t h e definitions d e f i n i t i o n s used u s e d in i n regulations r e g u l a t i o n s of o f each e a c h country. c o u n t r y . NOTE N O T E 3 3 In I n conjunction c o n j u n c t i o n with w i t h IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 and a n d IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 the t h e term t e r m “medical “ m e d i c a l device” d e v i c e ” assumes a s s u m e s the t h e same s a m e meaning m e a n i n g as a s ME M E EQUIPMENT E Q U I P M E N T or o r ME M E SYSTEM S Y S T E M (which ( w h i c h are a r e defined d e f i n e d terms t e r m s of o f IEC I E C 60601-1). 6 0 6 0 1 - 1 ) . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 12 1 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.12 3 . 1 2 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E SOFTWARE S O F T W A R E SYSTEM S Y S T E M that t h a t has h a s been b e e n developed d e v e l o p e d for f o r the t h e purpose p u r p o s e of o f being b e i n g incorporated i n c o r p o r a t e d into i n t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E being b e i n g developed d e v e l o p e d or o r that t h a t is i s intended i n t e n d e d for f o r use u s e as a s a a MEDICAL M E D I C A L DEVICE D E V I C E NOTE N O T E This T h i s includes i n c l u d e s a a MEDICAL M E D I C A L DEVICE D E V I C E software s o f t w a r e product, p r o d u c t , which w h i c h then t h e n is i s a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right. r i g h t . 3.13 3 . 1 3 PROBLEM P R O B L E M REPORT R E P O R T a a record r e c o r d of o f actual a c t u a l or o r potential p o t e n t i a l behaviour b e h a v i o u r of o f a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t a a user u s e r or o r other o t h e r interested i n t e r e s t e d person p e r s o n believes b e l i e v e s to t o be b e unsafe, u n s a f e , inappropriate i n a p p r o p r i a t e for f o r the t h e intended i n t e n d e d use u s e or o r contrary c o n t r a r y to t o specification s p e c i f i c a t i o n NOTE N O T E 1 1 This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t every e v e r y PROBLEM P R O B L E M REPORT R E P O R T results r e s u l t s in i n a a change c h a n g e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . A A MANUFACTURER M A N U F A C T U R E R can c a n reject r e j e c t a a PROBLEM P R O B L E M REPORT R E P O R T as a s a a misunderstanding, m i s u n d e r s t a n d i n g , error e r r o r or o r insignificant i n s i g n i f i c a n t event. e v e n t . NOTE N O T E 2 2 A A PROBLEM P R O B L E M REPORT R E P O R T can c a n relate r e l a t e to t o a a released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E or o r to t o a a MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t is i s still s t i l l under u n d e r development. d e v e l o p m e n t . NOTE N O T E 3 3 This T h i s standard s t a n d a r d requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o perform p e r f o r m extra e x t r a decision d e c i s i o n making m a k i n g steps s t e p s (see ( s e e Clause C l a u s e 6) 6 ) for f o r a a PROBLEM P R O B L E M REPORT R E P O R T relating r e l a t i n g to t o a a released r e l e a s e d product p r o d u c t to t o ensure e n s u r e that t h a t regulatory r e g u l a t o r y actions a c t i o n s are a r e identified i d e n t i f i e d and a n d implemented. i m p l e m e n t e d . 3.14 3 . 1 4 PROCESS P R O C E S S a a set s e t of o f interrelated i n t e r r e l a t e d or o r interacting i n t e r a c t i n g ACTIVITIES A C T I V I T I E S that t h a t transform t r a n s f o r m inputs i n p u t s into i n t o outputs o u t p u t s [ISO [ I S O 9000:2000, 9 0 0 0 : 2 0 0 0 , definition d e f i n i t i o n 3.4.1] 3 . 4 . 1 ] NOTE N O T E The T h e term t e r m “ACTIVITIES” “ A C T I V I T I E S ” covers c o v e r s use u s e of o f resources. r e s o u r c e s . 3.15 3 . 1 5 REGRESSION R E G R E S S I O N TESTING T E S T I N G the t h e testing t e s t i n g required r e q u i r e d to t o determine d e t e r m i n e that t h a t a a change c h a n g e to t o a a SYSTEM S Y S T E M component c o m p o n e n t has h a s not n o t adversely a d v e r s e l y affected a f f e c t e d functionality, f u n c t i o n a l i t y , reliability r e l i a b i l i t y or o r performance p e r f o r m a n c e and a n d has h a s not n o t introduced i n t r o d u c e d additional a d d i t i o n a l defects d e f e c t s [ISO/IEC [ I S O / I E C 90003:2004, 9 0 0 0 3 : 2 0 0 4 , definition d e f i n i t i o n 3.11] 3 . 1 1 ] 3.16 3 . 1 6 RISK R I S K combination c o m b i n a t i o n of o f the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f HARM H A R M and a n d the t h e severity s e v e r i t y of o f that t h a t HARM H A R M [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.16] 2 . 1 6 ] 3.17 3 . 1 7 RISK R I S K ANALYSIS A N A L Y S I S systematic s y s t e m a t i c use u s e of o f available a v a i l a b l e information i n f o r m a t i o n to t o identify i d e n t i f y HAZARDS H A Z A R D S and a n d to t o estimate e s t i m a t e the t h e RISK R I S K [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.17] 2 . 1 7 ] 3.18 3 . 1 8 RISK R I S K CONTROL C O N T R O L PROCESS P R O C E S S in i n which w h i c h decisions d e c i s i o n s are a r e made m a d e and a n d RISKS R I S K S are a r e reduced r e d u c e d to, t o , or o r maintained m a i n t a i n e d within, w i t h i n , specified s p e c i f i e d levels l e v e l s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.19] 2 . 1 9 ] 3.19 3 . 1 9 RISK R I S K MANAGEMENT M A N A G E M E N T systematic s y s t e m a t i c application a p p l i c a t i o n of o f management m a n a g e m e n t policies, p o l i c i e s , procedures, p r o c e d u r e s , and a n d practices p r a c t i c e s to t o the t h e TASKS T A S K S of o f analyzing, a n a l y z i n g , evaluating, e v a l u a t i n g , and a n d controlling c o n t r o l l i n g RISK R I S K [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.22, 2 . 2 2 , modified m o d i f i e d – – The T h e phrase p h r a s e "and " a n d monitoring" m o n i t o r i n g " has h a s been b e e n removed] r e m o v e d ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 13 1 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.20 3 . 2 0 RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E set s e t of o f records r e c o r d s and a n d other o t h e r documents, d o c u m e n t s , not n o t necessarily n e c e s s a r i l y contiguous, c o n t i g u o u s , that t h a t are a r e produced p r o d u c e d by b y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.23] 2 . 2 3 ] 3.21 3 . 2 1 SAFETY S A F E T Y freedom f r e e d o m from f r o m unacceptable u n a c c e p t a b l e RISK R I S K [ISO [ I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.24] 2 . 2 4 ] 3.22 3 . 2 2 SECURITY S E C U R I T Y protection p r o t e c t i o n of o f information i n f o r m a t i o n and a n d data d a t a so s o that t h a t unauthorized u n a u t h o r i z e d persons p e r s o n s or o r systems s y s t e m s cannot c a n n o t read r e a d or o r modify m o d i f y them t h e m an a n authorized a u t h o r i z e d persons p e r s o n s or o r systems s y s t e m s are a r e not n o t denied d e n i e d access a c c e s s to t o them t h e m NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207: 1 2 2 0 7 : 2008, 2 0 0 8 , 4.39. 4 . 3 9 . 3.23 3 . 2 3 SERIOUS S E R I O U S INJURY I N J U R Y injury i n j u r y or o r illness i l l n e s s that: t h a t : is i s life l i f e threatening, t h r e a t e n i n g , results r e s u l t s in i n permanent p e r m a n e n t impairment i m p a i r m e n t of o f a a body b o d y function f u n c t i o n or o r permanent p e r m a n e n t damage d a m a g e to t o a a body b o d y structure, s t r u c t u r e , or o r necessitates n e c e s s i t a t e s medical m e d i c a l or o r surgical s u r g i c a l intervention i n t e r v e n t i o n to t o prevent p r e v e n t permanent p e r m a n e n t impairment i m p a i r m e n t of o f a a body b o d y function f u n c t i o n or o r permanent p e r m a n e n t damage d a m a g e to t o a a body b o d y structure s t r u c t u r e NOTE N O T E Permanent P e r m a n e n t impairment i m p a i r m e n t means m e a n s an a n irreversible i r r e v e r s i b l e impairment i m p a i r m e n t or o r damage d a m a g e to t o a a body b o d y structure s t r u c t u r e or o r function f u n c t i o n excluding e x c l u d i n g trivial t r i v i a l impairment i m p a i r m e n t or o r damage. d a m a g e . 3.24 3 . 2 4 SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L conceptual c o n c e p t u a l structure s t r u c t u r e spanning s p a n n i n g the t h e life l i f e of o f the t h e software s o f t w a r e from f r o m definition d e f i n i t i o n of o f its i t s requirements r e q u i r e m e n t s to t o its i t s release, r e l e a s e , which: w h i c h : – – identifies i d e n t i f i e s the t h e PROCESS, P R O C E S S , ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S involved i n v o l v e d in i n development d e v e l o p m e n t of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , – – describes d e s c r i b e s the t h e sequence s e q u e n c e of o f and a n d dependency d e p e n d e n c y between b e t w e e n ACTIVITIES A C T I V I T I E S and a n d TASKS, T A S K S , and a n d – – identifies i d e n t i f i e s the t h e milestones m i l e s t o n e s at a t which w h i c h the t h e completeness c o m p l e t e n e s s of o f specified s p e c i f i e d DELIVERABLES D E L I V E R A B L E S is i s verified. v e r i f i e d . NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:1995, 1 2 2 0 7 : 1 9 9 5 , definition d e f i n i t i o n 3.11 3 . 1 1 3.25 3 . 2 5 SOFTWARE S O F T W A R E ITEM I T E M any a n y identifiable i d e n t i f i a b l e part p a r t of o f a a computer c o m p u t e r program, p r o g r a m , i.e., i . e . , source s o u r c e code, c o d e , object o b j e c t code, c o d e , control c o n t r o l code, c o d e , control c o n t r o l data, d a t a , or o r a a collection c o l l e c t i o n of o f these t h e s e items i t e m s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E Three T h r e e terms t e r m s identify i d e n t i f y the t h e software s o f t w a r e decomposition. d e c o m p o s i t i o n . The T h e top t o p level l e v e l is i s the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e lowest l o w e s t level l e v e l that t h a t is i s not n o t further f u r t h e r decomposed d e c o m p o s e d is i s the t h e SOFTWARE S O F T W A R E UNIT. U N I T . All A l l levels l e v e l s of o f composition, c o m p o s i t i o n , including i n c l u d i n g the t h e top t o p and a n d bottom b o t t o m levels, l e v e l s , can c a n be b e called c a l l e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , then, t h e n , is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d each e a c h SOFTWARE S O F T W A R E ITEM I T E M is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E UNITS U N I T S or o r decomposable d e c o m p o s a b l e SOFTWARE S O F T W A R E ITEMS. I T E M S . The T h e responsibility r e s p o n s i b i l i t y is i s left l e f t to t o the t h e MANUFACTURER M A N U F A C T U R E R to t o provide p r o v i d e the t h e granularity g r a n u l a r i t y of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SOFTWARE S O F T W A R E UNITS. U N I T S . NOTE N O T E 2 2 Based B a s e d on o n ISO/IEC I S O / I E C 90003:2004, 9 0 0 0 3 : 2 0 0 4 , 3.14 3 . 1 4 and a n d ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4.41 4 . 4 1 3.26 3 . 2 6 Not N o t used u s e d 3.27 3 . 2 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M integrated i n t e g r a t e d collection c o l l e c t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S organized o r g a n i z e d to t o accomplish a c c o m p l i s h a a specific s p e c i f i c function f u n c t i o n or o r set s e t of o f functions f u n c t i o n s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 3.28 3 . 2 8 SOFTWARE S O F T W A R E UNIT U N I T SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s not n o t subdivided s u b d i v i d e d into i n t o other o t h e r items i t e m s – – 14 1 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E The T h e granularity g r a n u l a r i t y of o f SOFTWARE S O F T W A R E UNITS U N I T S is i s defined d e f i n e d by b y the t h e MANUFACTURER M A N U F A C T U R E R (see ( s e e B.3). B . 3 ) . 3.29 3 . 2 9 SOUP S O U P software s o f t w a r e of o f unknown u n k n o w n provenance p r o v e n a n c e (acronym) ( a c r o n y m ) SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s already a l r e a d y developed d e v e l o p e d and a n d generally g e n e r a l l y available a v a i l a b l e and a n d that t h a t has h a s not n o t been b e e n developed d e v e l o p e d for f o r the t h e purpose p u r p o s e of o f being b e i n g incorporated i n c o r p o r a t e d into i n t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E (also ( a l s o known k n o w n as a s “off- “ o f f - the- t h e - shelf s h e l f software”) s o f t w a r e ” ) or o r SOFTWARE S O F T W A R E ITEM I T E M previously p r e v i o u s l y developed d e v e l o p e d for f o r which w h i c h adequate a d e q u a t e records r e c o r d s of o f the t h e development d e v e l o p m e n t PROCESSES P R O C E S S E S are a r e not n o t available a v a i l a b l e NOTE N O T E A A MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E SYSTEM S Y S T E M in i n itself i t s e l f cannot c a n n o t be b e claimed c l a i m e d to t o be b e SOUP. S O U P . 3.30 3 . 3 0 SYSTEM S Y S T E M integrated i n t e g r a t e d composite c o m p o s i t e consisting c o n s i s t i n g of o f one o n e or o r more m o r e of o f the t h e PROCESSES, P R O C E S S E S , hardware, h a r d w a r e , software, s o f t w a r e , facilities, f a c i l i t i e s , and a n d people, p e o p l e , that t h a t provides p r o v i d e s a a capability c a p a b i l i t y to t o satisfy s a t i s f y a a stated s t a t e d need n e e d or o r objective o b j e c t i v e NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4.48. 4 . 4 8 . 3.31 3 . 3 1 TASK T A S K a a single s i n g l e piece p i e c e of o f work w o r k that t h a t needs n e e d s to t o be b e done d o n e 3.32 3 . 3 2 TRACEABILITY T R A C E A B I L I T Y degree d e g r e e to t o which w h i c h a a relationship r e l a t i o n s h i p can c a n be b e established e s t a b l i s h e d between b e t w e e n two t w o or o r more m o r e products p r o d u c t s of o f the t h e development d e v e l o p m e n t PROCESS P R O C E S S [IEEE [ I E E E 610.12:1990] 6 1 0 . 1 2 : 1 9 9 0 ] NOTE N O T E Requirements, R e q u i r e m e n t s , architecture, a r c h i t e c t u r e , risk r i s k control c o n t r o l measures, m e a s u r e s , etc. e t c . are a r e examples e x a m p l e s of o f deliverables d e l i v e r a b l e s of o f the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . 3.33 3 . 3 3 VERIFICATION V E R I F I C A T I O N confirmation c o n f i r m a t i o n through t h r o u g h provision p r o v i s i o n of o f objective o b j e c t i v e evidence e v i d e n c e that t h a t specified s p e c i f i e d requirements r e q u i r e m e n t s have h a v e been b e e n fulfilled f u l f i l l e d NOTE N O T E 1 1 “Verified” “ V e r i f i e d ” is i s used u s e d to t o designate d e s i g n a t e the t h e corresponding c o r r e s p o n d i n g status. s t a t u s . [ISO [ I S O 9000:2000, 9 0 0 0 : 2 0 0 0 , definition d e f i n i t i o n 3.8.4] 3 . 8 . 4 ] NOTE N O T E 2 2 In I n design d e s i g n and a n d development, d e v e l o p m e n t , VERIFICATION V E R I F I C A T I O N concerns c o n c e r n s the t h e PROCESS P R O C E S S of o f examining e x a m i n i n g the t h e result r e s u l t of o f a a given g i v e n ACTIVITY A C T I V I T Y to t o determine d e t e r m i n e conformity c o n f o r m i t y with w i t h the t h e stated s t a t e d requirement r e q u i r e m e n t for f o r that t h a t ACTIVITY. A C T I V I T Y . 3.34 3 . 3 4 VERSION V E R S I O N identified i d e n t i f i e d instance i n s t a n c e of o f a a CONFIGURATION C O N F I G U R A T I O N ITEM I T E M Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E 1 1 Modification M o d i f i c a t i o n to t o a a VERSION V E R S I O N of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , resulting r e s u l t i n g in i n a a new n e w VERSION, V E R S I O N , requires r e q u i r e s software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t action. a c t i o n . NOTE N O T E 2 2 Based B a s e d on o n ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , 4.56. 4 . 5 6 . 3.35 3 . 3 5 HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N circumstance c i r c u m s t a n c e in i n which w h i c h people, p e o p l e , property p r o p e r t y or o r the t h e environment e n v i r o n m e n t are a r e exposed e x p o s e d to t o one o n e or o r more m o r e HAZARD(S) H A Z A R D ( S ) [SOURCE: [ S O U R C E : ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.4] 2 . 4 ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 15 1 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 3.36 3 . 3 6 LEGACY L E G A C Y SOFTWARE S O F T W A R E MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E which w h i c h was w a s legally l e g a l l y placed p l a c e d on o n the t h e market m a r k e t and a n d is i s still s t i l l marketed m a r k e t e d today t o d a y but b u t for f o r which w h i c h there t h e r e is i s insufficient i n s u f f i c i e n t objective o b j e c t i v e evidence e v i d e n c e that t h a t it i t was w a s developed d e v e l o p e d in i n compliance c o m p l i a n c e with w i t h the t h e current c u r r e n t version v e r s i o n of o f this t h i s standard s t a n d a r d 3.37 3 . 3 7 RELEASE R E L E A S E particular p a r t i c u l a r VERSION V E R S I O N of o f a a CONFIGURATION C O N F I G U R A T I O N ITEM I T E M that t h a t is i s made m a d e available a v a i l a b l e for f o r a a specific s p e c i f i c purpose p u r p o s e NOTE N O T E Based B a s e d on o n ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , definition d e f i n i t i o n 4.35. 4 . 3 5 . 3.38 3 . 3 8 RESIDUAL R E S I D U A L RISK R I S K RISK R I S K remaining r e m a i n i n g after a f t e r RISK R I S K CONTROL C O N T R O L measures m e a s u r e s have h a v e been b e e n taken t a k e n NOTE N O T E 1 1 Adapted A d a p t e d from f r o m ISO/IEC I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.9. 3 . 9 . NOTE N O T E 2 2 ISO/IEC I S O / I E C Guide G u i d e 51:1999, 5 1 : 1 9 9 9 , definition d e f i n i t i o n 3.9 3 . 9 uses u s e s the t h e term t e r m “protective “ p r o t e c t i v e measures” m e a s u r e s ” rather r a t h e r than t h a n “RISK “ R I S K CONTROL C O N T R O L measures.” m e a s u r e s . ” However, H o w e v e r , in i n the t h e context c o n t e x t of o f this t h i s International I n t e r n a t i o n a l Standard, S t a n d a r d , “protective “ p r o t e c t i v e measures” m e a s u r e s ” are a r e only o n l y one o n e option o p t i o n for f o r controlling c o n t r o l l i n g RISK R I S K as a s described d e s c r i b e d in i n 6.2 6 . 2 [of [ o f ISO I S O 14971:2007]. 1 4 9 7 1 : 2 0 0 7 ] . [SOURCE: [ S O U R C E : ISO I S O 14971:2007, 1 4 9 7 1 : 2 0 0 7 , 2.15]. 2 . 1 5 ] . 3.39 3 . 3 9 RISK R I S K ESTIMATION E S T I M A T I O N PROCESS P R O C E S S used u s e d to t o assign a s s i g n values v a l u e s to t o the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f HARM H A R M and a n d the t h e severity s e v e r i t y of o f that t h a t HARM H A R M [SOURCE: [ S O U R C E : ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 2.20] 2 . 2 0 ] 3.40 3 . 4 0 RISK R I S K EVALUATION E V A L U A T I O N PROCESS P R O C E S S of o f comparing c o m p a r i n g the t h e estimated e s t i m a t e d RISK R I S K against a g a i n s t given g i v e n RISK R I S K criteria c r i t e r i a to t o determine d e t e r m i n e the t h e acceptability a c c e p t a b i l i t y of o f the t h e RISK R I S K [SOURCE: [ S O U R C E : ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 2.21] 2 . 2 1 ] 4 4 * * General G e n e r a l requirements r e q u i r e m e n t s 4.1 4 . 1 * * Quality Q u a l i t y management m a n a g e m e n t system s y s t e m The T h e MANUFACTURER M A N U F A C T U R E R of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E shall s h a l l demonstrate d e m o n s t r a t e the t h e ability a b i l i t y to t o provide p r o v i d e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t consistently c o n s i s t e n t l y meets m e e t s customer c u s t o m e r requirements r e q u i r e m e n t s and a n d applicable a p p l i c a b l e regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . NOTE N O T E 1 1 Demonstration D e m o n s t r a t i o n of o f this t h i s ability a b i l i t y can c a n be b e by b y the t h e use u s e of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m that t h a t complies c o m p l i e s with: w i t h : - - ISO I S O 13485 1 3 4 8 5 [8]; [ 8 ] ; or o r - - a a national n a t i o n a l quality q u a l i t y management m a n a g e m e n t system s y s t e m standard; s t a n d a r d ; or o r - - a a quality q u a l i t y management m a n a g e m e n t system s y s t e m required r e q u i r e d by b y national n a t i o n a l regulation. r e g u l a t i o n . NOTE N O T E 2 2 Guidance G u i d a n c e for f o r applying a p p l y i n g quality q u a l i t y management m a n a g e m e n t system s y s t e m requirements r e q u i r e m e n t s to t o software s o f t w a r e can c a n be b e found f o u n d in i n ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15]. [ 1 5 ] . 4.2 4 . 2 * * RISK R I S K MANAGEMENT M A N A G E M E N T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l apply a p p l y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S complying c o m p l y i n g with w i t h ISO I S O 14971. 1 4 9 7 1 . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 4.3 4 . 3 * * Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n – – 16 1 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l assign a s s i g n to t o each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M a a software s o f t w a r e safety s a f e t y class c l a s s (A, ( A , B, B , or o r C) C ) according a c c o r d i n g to t o the t h e RISK R I S K of o f HARM H A R M to t o the t h e patient, p a t i e n t , operator, o p e r a t o r , or o r other o t h e r people p e o p l e resulting r e s u l t i n g from f r o m a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N to t o which w h i c h the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e in i n a a worst-case- w o r s t - c a s e - scenario s c e n a r i o as a s indicated i n d i c a t e d in i n Figure F i g u r e 3. 3 . IEC I E C Figure F i g u r e 3 3 – – Assigning A s s i g n i n g software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s A A if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M cannot c a n n o t contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION; S I T U A T I O N ; or o r – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h does d o e s not n o t result r e s u l t in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s B B if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h results r e s u l t s in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d the t h e resulting r e s u l t i n g possible p o s s i b l e HARM H A R M is i s non-SERIOUS n o n - S E R I O U S INJURY. I N J U R Y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s C C if: i f : – – the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N which w h i c h results r e s u l t s in i n unacceptable u n a c c e p t a b l e RISK R I S K after a f t e r consideration c o n s i d e r a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d the t h e resulting r e s u l t i n g possible p o s s i b l e HARM H A R M is i s death d e a t h or o r SERIOUS S E R I O U S INJURY. I N J U R Y . For F o r a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M initially i n i t i a l l y classified c l a s s i f i e d as a s software s o f t w a r e safety s a f e t y class c l a s s B B or o r C, C , the t h e MANUFACTURER M A N U F A C T U R E R may m a y implement i m p l e m e n t additional a d d i t i o n a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M (including ( i n c l u d i n g revising r e v i s i n g the t h e system s y s t e m architecture a r c h i t e c t u r e containing c o n t a i n i n g the t h e SOFTWARE S O F T W A R E SYSTEM) S Y S T E M ) and a n d subsequently s u b s e q u e n t l y assign a s s i g n a a new n e w software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n to t o the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . NOTE N O T E 1 1 External E x t e r n a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s can c a n be b e hardware, h a r d w a r e , an a n independent i n d e p e n d e n t SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , health h e a l t h care c a r e procedures, p r o c e d u r e s , or o r other o t h e r means m e a n s to t o minimize m i n i m i z e that t h a t software s o f t w a r e can c a n contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . NOTE N O T E 2 2 See S e e ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 subclause s u b c l a u s e 3.2, 3 . 2 , Management M a n a g e m e n t Responsibilities, R e s p o n s i b i l i t i e s , for f o r the t h e definition d e f i n i t i o n of o f risk r i s k acceptability. a c c e p t a b i l i t y . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 17 1 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Not N o t used. u s e d . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e software s o f t w a r e safety s a f e t y class c l a s s assigned a s s i g n e d to t o each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . When W h e n a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s decomposed d e c o m p o s e d into i n t o SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d when w h e n a a SOFTWARE S O F T W A R E ITEM I T E M is i s decomposed d e c o m p o s e d into i n t o further f u r t h e r SOFTWARE S O F T W A R E ITEMS, I T E M S , such s u c h SOFTWARE S O F T W A R E ITEMS I T E M S shall s h a l l inherit i n h e r i t the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e original o r i g i n a l SOFTWARE S O F T W A R E ITEM I T E M (or ( o r SOFTWARE S O F T W A R E SYSTEM) S Y S T E M ) unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R documents d o c u m e n t s a a rationale r a t i o n a l e for f o r classification c l a s s i f i c a t i o n into i n t o a a different d i f f e r e n t software s o f t w a r e safety s a f e t y class c l a s s (software ( s o f t w a r e safety s a f e t y classes c l a s s e s assigned a s s i g n e d according a c c o r d i n g to t o 4.3 4 . 3 a) a ) replacing r e p l a c i n g “SOFTWARE “ S O F T W A R E SYSTEM” S Y S T E M ” with w i t h “SOFTWARE “ S O F T W A R E ITEM”). I T E M ” ) . Such S u c h a a rationale r a t i o n a l e shall s h a l l explain e x p l a i n how h o w the t h e new n e w SOFTWARE S O F T W A R E ITEMS I T E M S are a r e segregated s e g r e g a t e d so s o that t h a t they t h e y may m a y be b e classified c l a s s i f i e d separately. s e p a r a t e l y . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e software s o f t w a r e safety s a f e t y class c l a s s of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M if i f that t h a t class c l a s s is i s different d i f f e r e n t from f r o m the t h e class c l a s s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M from f r o m which w h i c h it i t was w a s created c r e a t e d by b y decomposition. d e c o m p o s i t i o n . For F o r compliance c o m p l i a n c e with w i t h this t h i s standard, s t a n d a r d , when w h e n applying a p p l y i n g this t h i s standard s t a n d a r d to t o a a group g r o u p of o f SOFTWARE S O F T W A R E ITEMS, I T E M S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e PROCESSES P R O C E S S E S and a n d TASKS T A S K S which w h i c h are a r e required r e q u i r e d by b y the t h e classification c l a s s i f i c a t i o n of o f the t h e highest-classified h i g h e s t - c l a s s i f i e d SOFTWARE S O F T W A R E ITEM I T E M in i n the t h e group g r o u p unless u n l e s s the t h e MANUFACTURER M A N U F A C T U R E R documents d o c u m e n t s in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E a a rationale r a t i o n a l e for f o r using u s i n g a a lower l o w e r classification. c l a s s i f i c a t i o n . For F o r each e a c h SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , until u n t i l a a software s o f t w a r e safety s a f e t y class c l a s s is i s assigned, a s s i g n e d , Class C l a s s C C requirements r e q u i r e m e n t s shall s h a l l apply. a p p l y . NOTE N O T E In I n the t h e clauses c l a u s e s and a n d subclauses s u b c l a u s e s that t h a t follow, f o l l o w , the t h e software s o f t w a r e safety s a f e t y classesfor c l a s s e s f o r which w h i c h a a specific s p e c i f i c requirement r e q u i r e m e n t applies a p p l i e s are a r e identified i d e n t i f i e d following f o l l o w i n g the t h e requirement r e q u i r e m e n t in i n the t h e form f o r m [Class [ C l a s s . . . . .]. . ] . 4.4 4 . 4 * * LEGACY L E G A C Y SOFTWARE S O F T W A R E 4.4.1 4 . 4 . 1 General G e n e r a l As A s an a n alternative a l t e r n a t i v e to t o applying a p p l y i n g Clauses C l a u s e s 5 5 through t h r o u g h 9 9 of o f this t h i s standard, s t a n d a r d , compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E may m a y be b e demonstrated d e m o n s t r a t e d as a s indicated i n d i c a t e d in i n 4.4.2 4 . 4 . 2 to t o 4.4.5. 4 . 4 . 5 . 4.4.2 4 . 4 . 2 RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S In I n accordance a c c o r d a n c e with w i t h 4.2 4 . 2 of o f this t h i s standard, s t a n d a r d , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : assess a s s e s s any a n y feedback, f e e d b a c k , including i n c l u d i n g post-production p o s t - p r o d u c t i o n information, i n f o r m a t i o n , on o n LEGACY L E G A C Y SOFTWARE S O F T W A R E regarding r e g a r d i n g incidents i n c i d e n t s and a n d / / or o r near n e a r incidents, i n c i d e n t s , both b o t h from f r o m inside i n s i d e its i t s own o w n organization o r g a n i z a t i o n and a n d / / or o r from f r o m users; u s e r s ; perform p e r f o r m RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S associated a s s o c i a t e d with w i t h continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , considering c o n s i d e r i n g the t h e following f o l l o w i n g aspects: a s p e c t s : – – integration i n t e g r a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E architecture; a r c h i t e c t u r e ; – – continuing c o n t i n u i n g validity v a l i d i t y of o f RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , implemented i m p l e m e n t e d as a s part p a r t of o f the t h e LEGACY L E G A C Y SOFTWARE; S O F T W A R E ; – – identification i d e n t i f i c a t i o n of o f HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S associated a s s o c i a t e d with w i t h the t h e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE; S O F T W A R E ; – – identification i d e n t i f i c a t i o n of o f potential p o t e n t i a l causes c a u s e s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E contributing c o n t r i b u t i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION; S I T U A T I O N ; – – definition d e f i n i t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s for f o r each e a c h potential p o t e n t i a l cause c a u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E contributing c o n t r i b u t i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 4.4.3 4 . 4 . 3 Gap G a p analysis a n a l y s i s Based B a s e d on o n the t h e software s o f t w a r e safety s a f e t y class c l a s s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E (see ( s e e 4.3), 4 . 3 ) , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m a a gap g a p analysis a n a l y s i s of o f available a v a i l a b l e DELIVERABLES D E L I V E R A B L E S against a g a i n s t those t h o s e required r e q u i r e d according a c c o r d i n g to t o 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7. 7 . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l assess a s s e s s the t h e continuing c o n t i n u i n g validity v a l i d i t y of o f available a v a i l a b l e DELIVERABLES. D E L I V E R A B L E S . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 18 1 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Where W h e r e gaps g a p s are a r e identified, i d e n t i f i e d , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e potential p o t e n t i a l reduction r e d u c t i o n in i n RISK R I S K resulting r e s u l t i n g from f r o m the t h e generation g e n e r a t i o n of o f the t h e missing m i s s i n g DELIVERABLES D E L I V E R A B L E S and a n d associated a s s o c i a t e d ACTIVITIES. A C T I V I T I E S . Based B a s e d on o n this t h i s evaluation, e v a l u a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l determine d e t e r m i n e the t h e DELIVERABLES D E L I V E R A B L E S to t o be b e created c r e a t e d and a n d associated a s s o c i a t e d ACTIVITIES A C T I V I T I E S to t o be b e performed. p e r f o r m e d . The T h e minimum m i n i m u m DELIVERABLE D E L I V E R A B L E shall s h a l l be b e SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t records r e c o r d s (see ( s e e 5.7.5). 5 . 7 . 5 ) . NOTE N O T E Such S u c h gap g a p analysis a n a l y s i s should s h o u l d assure a s s u r e that t h a t RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , implemented i m p l e m e n t e d in i n LEGACY L E G A C Y SOFTWARE, S O F T W A R E , are a r e included i n c l u d e d in i n the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . 4.4.4 4 . 4 . 4 Gap G a p closure c l o s u r e activities a c t i v i t i e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h and a n d execute e x e c u t e a a plan p l a n to t o generate g e n e r a t e the t h e identified i d e n t i f i e d DELIVERABLES. D E L I V E R A B L E S . Where W h e r e available, a v a i l a b l e , objective o b j e c t i v e evidence e v i d e n c e may m a y be b e used u s e d to t o generate g e n e r a t e required r e q u i r e d DELIVERABLES D E L I V E R A B L E S without w i t h o u t performing p e r f o r m i n g ACTIVITIES A C T I V I T I E S required r e q u i r e d by b y 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7 5 . 7 and a n d Clause C l a u s e 7. 7 . NOTE N O T E A A plan p l a n on o n how h o w to t o address a d d r e s s the t h e identified i d e n t i f i e d gaps g a p s can c a n be b e included i n c l u d e d in i n a a software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n (see ( s e e 6.1). 6 . 1 ) . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e use u s e of o f the t h e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S for f o r handling h a n d l i n g problems p r o b l e m s detected d e t e c t e d in i n the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d DELIVERABLES D E L I V E R A B L E S in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 9. 9 . Changes C h a n g e s to t o the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E shall s h a l l be b e performed p e r f o r m e d in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 6. 6 . 4.4.5 4 . 4 . 5 Rationale R a t i o n a l e for f o r use u s e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E together t o g e t h e r with w i t h a a rationale r a t i o n a l e for f o r the t h e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E based b a s e d on o n the t h e outputs o u t p u t s of o f 4.4. 4 . 4 . NOTE N O T E Fulfilling F u l f i l l i n g 4.4 4 . 4 enables e n a b l e s further f u r t h e r use u s e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n accordance a c c o r d a n c e with w i t h IEC I E C 62304. 6 2 3 0 4 . 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S 5.1 5 . 1 * * Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a software s o f t w a r e development d e v e l o p m e n t plan p l a n (or ( o r plans) p l a n s ) for f o r conducting c o n d u c t i n g the t h e ACTIVITIES A C T I V I T I E S of o f the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S appropriate a p p r o p r i a t e to t o the t h e scope, s c o p e , magnitude, m a g n i t u d e , and a n d software s o f t w a r e safety s a f e t y classifications c l a s s i f i c a t i o n s of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M to t o be b e developed. d e v e l o p e d . The T h e sOFTWARE s O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L shall s h a l l either e i t h e r be b e fully f u l l y defined d e f i n e d or o r be b e referenced r e f e r e n c e d in i n the t h e plan p l a n (or ( o r plans). p l a n s ) . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e following: f o l l o w i n g : the t h e PROCESSES P R O C E S S E S to t o be b e used u s e d in i n the t h e development d e v e l o p m e n t of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M (see ( s e e Note N o t e 4); 4 ) ; the t h e DELIVERABLES D E L I V E R A B L E S (includes ( i n c l u d e s documentation) d o c u m e n t a t i o n ) of o f the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS; T A S K S ; TRACEABILITY T R A C E A B I L I T Y between b e t w e e n SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , software s o f t w a r e requirements, r e q u i r e m e n t s , SOFTWARE S O F T W A R E SYSTEM S Y S T E M test, t e s t , and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software; s o f t w a r e ; software s o f t w a r e configuration c o n f i g u r a t i o n and a n d change c h a n g e management, m a n a g e m e n t , including i n c l u d i n g SOUP S O U P CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d software s o f t w a r e used u s e d to t o support s u p p o r t development; d e v e l o p m e n t ; and a n d software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n for f o r handling h a n d l i n g problems p r o b l e m s detected d e t e c t e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , DELIVERABLES D E L I V E R A B L E S and a n d ACTIVITIES A C T I V I T I E S at a t each e a c h stage s t a g e of o f the t h e life l i f e cycle. c y c l e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 1 1 The T h e SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L can c a n identify i d e n t i f y different d i f f e r e n t elements e l e m e n t s (PROCESSES, ( P R O C E S S E S , ACTIVITIES, A C T I V I T I E S , TASKS T A S K S and a n d DELIVERABLES) D E L I V E R A B L E S ) for f o r different d i f f e r e n t SOFTWARE S O F T W A R E ITEMS I T E M S according a c c o r d i n g to t o the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M of o f the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . NOTE N O T E 2 2 These T h e s e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S can c a n overlap o v e r l a p or o r interact i n t e r a c t and a n d can c a n be b e performed p e r f o r m e d iteratively i t e r a t i v e l y or o r recursively. r e c u r s i v e l y . It I t is i s not n o t the t h e intent i n t e n t to t o imply i m p l y that t h a t a a specific s p e c i f i c life l i f e cycle c y c l e model m o d e l should s h o u l d be b e used. u s e d . NOTE N O T E 3 3 Other O t h e r PROCESSES P R O C E S S E S are a r e described d e s c r i b e d in i n this t h i s standard s t a n d a r d separately s e p a r a t e l y from f r o m the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . This T h i s does d o e s not n o t imply i m p l y that t h a t they t h e y must m u s t be b e implemented i m p l e m e n t e d as a s separate s e p a r a t e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . The T h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e other o t h e r PROCESSES P R O C E S S E S can c a n be b e integrated i n t e g r a t e d into i n t o the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . NOTE N O T E 4 4 The T h e software s o f t w a r e development d e v e l o p m e n t plan p l a n can c a n reference r e f e r e n c e existing e x i s t i n g PROCESSES P R O C E S S E S or o r define d e f i n e new n e w ones. o n e s . NOTE N O T E 5 5 The T h e software s o f t w a r e development d e v e l o p m e n t plan p l a n may m a y be b e integrated i n t e g r a t e d in i n an a n overall o v e r a l l SYSTEM S Y S T E M development d e v e l o p m e n t plan. p l a n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 19 1 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.1.2 5 . 1 . 2 Keep K e e p software s o f t w a r e development d e v e l o p m e n t plan p l a n updated u p d a t e d The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l update u p d a t e the t h e plan p l a n as a s development d e v e l o p m e n t proceeds p r o c e e d s as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] 5.1.3 5 . 1 . 3 Software S o f t w a r e development d e v e l o p m e n t plan p l a n reference r e f e r e n c e to t o SYSTEM S Y S T E M design d e s i g n and a n d development d e v e l o p m e n t As A s inputs i n p u t s for f o r software s o f t w a r e development, d e v e l o p m e n t , SYSTEM S Y S T E M requirements r e q u i r e m e n t s shall s h a l l be b e referenced r e f e r e n c e d in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n by b y the t h e MANUFACTURER. M A N U F A C T U R E R . In I n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e procedures p r o c e d u r e s for f o r coordinating c o o r d i n a t i n g the t h e software s o f t w a r e development d e v e l o p m e n t with w i t h the t h e system s y s t e m development d e v e l o p m e n t necessary n e c e s s a r y to t o satisfy s a t i s f y 4.1 4 . 1 (such ( s u c h as a s system s y s t e m integration, i n t e g r a t i o n , verification, v e r i f i c a t i o n , and a n d validation). v a l i d a t i o n ) . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E There T h e r e might m i g h t not n o t be b e a a difference d i f f e r e n c e between b e t w e e n SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s if i f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a stand s t a n d alone a l o n e SYSTEM S Y S T E M (software-only ( s o f t w a r e - o n l y device). d e v i c e ) . 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan: p l a n : standards, s t a n d a r d s , methods, m e t h o d s , and a n d tools t o o l s associated a s s o c i a t e d with w i t h the t h e development d e v e l o p m e n t of o f SOFTWARE S O F T W A R E ITEMS I T E M S of o f class c l a s s C. C . [Class [ C l a s s C] C ] 5.1.5 5 . 1 . 5 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , a a plan p l a n to t o integrate i n t e g r a t e the t h e SOFTWARE S O F T W A R E ITEMS I T E M S (including ( i n c l u d i n g SOUP) S O U P ) and a n d perform p e r f o r m testing t e s t i n g during d u r i n g integration. i n t e g r a t i o n . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . NOTE N O T E 2 2 See S e e 5.6. 5 . 6 . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n the t h e following f o l l o w i n g VERIFICATION V E R I F I C A T I O N information: i n f o r m a t i o n : DELIVERABLES D E L I V E R A B L E S requiring r e q u i r i n g VERIFICATION; V E R I F I C A T I O N ; the t h e required r e q u i r e d VERIFICATION V E R I F I C A T I O N TASKS T A S K S for f o r each e a c h life l i f e cycle c y c l e ACTIVITY; A C T I V I T Y ; milestones m i l e s t o n e s at a t which w h i c h the t h e DELIVERABLES D E L I V E R A B L E S are a r e VERIFIED; V E R I F I E D ; and a n d the t h e acceptance a c c e p t a n c e criteria c r i t e r i a for f o r VERIFICATION V E R I F I C A T I O N of o f the t h e DELIVERABLES. D E L I V E R A B L E S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] 5.1.7 5 . 1 . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan, p l a n , a a plan p l a n to t o conduct c o n d u c t the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS, P R O C E S S , including i n c l u d i n g the t h e management m a n a g e m e n t of o f RISKS R I S K S relating r e l a t i n g to t o SOUP. S O U P . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 7. 7 . 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n information i n f o r m a t i o n about a b o u t the t h e documents d o c u m e n t s to t o be b e produced p r o d u c e d during d u r i n g the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle. c y c l e . For F o r each e a c h granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 20 2 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 identified i d e n t i f i e d document d o c u m e n t or o r type t y p e of o f document d o c u m e n t the t h e following f o l l o w i n g information i n f o r m a t i o n shall s h a l l be b e included i n c l u d e d or o r referenced: r e f e r e n c e d : title, t i t l e , name n a m e or o r naming n a m i n g convention; c o n v e n t i o n ; purpose; p u r p o s e ; procedures p r o c e d u r e s and a n d responsibilities r e s p o n s i b i l i t i e s for f o r development, d e v e l o p m e n t , review, r e v i e w , approval a p p r o v a l and a n d modification. m o d i f i c a t i o n . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 8 8 for f o r consideration c o n s i d e r a t i o n of o f configuration c o n f i g u r a t i o n management m a n a g e m e n t of o f documentation. d o c u m e n t a t i o n . 5.1.9 5 . 1 . 9 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t planning p l a n n i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t information i n f o r m a t i o n in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan. p l a n . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t information i n f o r m a t i o n shall s h a l l include i n c l u d e or o r reference: r e f e r e n c e : the t h e classes, c l a s s e s , types, t y p e s , categories c a t e g o r i e s or o r lists l i s t s of o f items i t e m s to t o be b e controlled; c o n t r o l l e d ; the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t ACTIVITIES A C T I V I T I E S and a n d TASKS; T A S K S ; the t h e organization(s) o r g a n i z a t i o n ( s ) responsible r e s p o n s i b l e for f o r performing p e r f o r m i n g software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t ACTIVITIES; A C T I V I T I E S ; their t h e i r relationship r e l a t i o n s h i p with w i t h other o t h e r organizations, o r g a n i z a t i o n s , such s u c h as a s software s o f t w a r e development d e v e l o p m e n t or o r maintenance; m a i n t e n a n c e ; when w h e n the t h e items i t e m s are a r e to t o be b e placed p l a c e d under u n d e r configuration c o n f i g u r a t i o n control; c o n t r o l ; and a n d when w h e n the t h e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S is i s to t o be b e used. u s e d . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 8. 8 . 5.1.10 5 . 1 . 1 0 Supporting S u p p o r t i n g items i t e m s to t o be b e controlled c o n t r o l l e d The T h e items i t e m s to t o be b e controlled c o n t r o l l e d shall s h a l l include i n c l u d e tools, t o o l s , items i t e m s or o r settings, s e t t i n g s , used u s e d to t o develop d e v e l o p the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , which w h i c h could c o u l d impact i m p a c t the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 Examples E x a m p l e s of o f such s u c h items i t e m s include i n c l u d e compiler/assembler c o m p i l e r / a s s e m b l e r versions, v e r s i o n s , make m a k e files, f i l e s , batch b a t c h files, f i l e s , and a n d specific s p e c i f i c environment e n v i r o n m e n t settings. s e t t i n g s . NOTE N O T E 2 2 See S e e Clause C l a u s e 8. 8 . 5.1.11 5 . 1 . 1 1 Software S o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEM I T E M control c o n t r o l before b e f o r e VERIFICATION V E R I F I C A T I O N The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l plan p l a n to t o place p l a c e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S under u n d e r configuration c o n f i g u r a t i o n management m a n a g e m e n t control c o n t r o l before b e f o r e they t h e y are a r e VERIFIED. V E R I F I E D . [Class [ C l a s s B, B , C] C ] 5.1.12 5 . 1 . 1 2 Identification I d e n t i f i c a t i o n and a n d avoidance a v o i d a n c e of o f common c o m m o n software s o f t w a r e defects d e f e c t s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e or o r reference r e f e r e n c e in i n the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n a a procedure p r o c e d u r e for: f o r : identifying i d e n t i f y i n g categories c a t e g o r i e s of o f defects d e f e c t s that t h a t may m a y be b e introduced i n t r o d u c e d based b a s e d on o n the t h e selected s e l e c t e d programming p r o g r a m m i n g technology t e c h n o l o g y that t h a t are a r e relevant r e l e v a n t to t o their t h e i r SOFTWARE S O F T W A R E SYSTEM; S Y S T E M ; and a n d documenting d o c u m e n t i n g evidence e v i d e n c e that t h a t demonstrates d e m o n s t r a t e s that t h a t these t h e s e defects d e f e c t s do d o not n o t contribute c o n t r i b u t e to t o unacceptable u n a c c e p t a b l e RISK. R I S K . NOTE N O T E See S e e Annex A n n e x B B of o f IEC I E C TR T R 80002-1:2009 8 0 0 0 2 - 1 : 2 0 0 9 for f o r examples e x a m p l e s of o f categories c a t e g o r i e s of o f defects d e f e c t s or o r causes c a u s e s contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS. S I T U A T I O N S . [Class [ C l a s s B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 21 2 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.2 5 . 2 * * Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements r e q u i r e m e n t s For F o r each e a c h SOFTWARE S O F T W A R E SYSTEM S Y S T E M of o f the t h e MEDICAL M E D I C A L DEVICE, D E V I C E , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l define d e f i n e and a n d document d o c u m e n t SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s from f r o m the t h e SYSTEM S Y S T E M level l e v e l requirements. r e q u i r e m e n t s . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E There T h e r e might m i g h t not n o t be b e a a difference d i f f e r e n c e between b e t w e e n SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s if i f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a stand s t a n d alone a l o n e SYSTEM S Y S T E M (software-only ( s o f t w a r e - o n l y device). d e v i c e ) . 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t As A s appropriate a p p r o p r i a t e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e in i n the t h e software s o f t w a r e requirements: r e q u i r e m e n t s : functional f u n c t i o n a l and a n d capability c a p a b i l i t y requirements; r e q u i r e m e n t s ; NOTE N O T E 1 1 Examples E x a m p l e s include: i n c l u d e : – – performance p e r f o r m a n c e (e.g., ( e . g . , purpose p u r p o s e of o f software, s o f t w a r e , timing t i m i n g requirements), r e q u i r e m e n t s ) , – – physical p h y s i c a l characteristics c h a r a c t e r i s t i c s (e.g., ( e . g . , code c o d e language, l a n g u a g e , platform, p l a t f o r m , operating o p e r a t i n g system), s y s t e m ) , – – computing c o m p u t i n g environment e n v i r o n m e n t (e.g., ( e . g . , hardware, h a r d w a r e , memory m e m o r y size, s i z e , processing p r o c e s s i n g unit, u n i t , time t i m e zone, z o n e , network n e t w o r k infrastructure) i n f r a s t r u c t u r e ) under u n d e r which w h i c h the t h e software s o f t w a r e is i s to t o perform, p e r f o r m , and a n d – – need n e e d for f o r compatibility c o m p a t i b i l i t y with w i t h upgrades u p g r a d e s or o r multiple m u l t i p l e SOUP S O U P or o r other o t h e r device d e v i c e versions. v e r s i o n s . SOFTWARE S O F T W A R E SYSTEM S Y S T E M inputs i n p u t s and a n d outputs; o u t p u t s ; NOTE N O T E 2 2 Examples E x a m p l e s include: i n c l u d e : – – data d a t a characteristics c h a r a c t e r i s t i c s (e.g., ( e . g . , numerical, n u m e r i c a l , alpha-numeric, a l p h a - n u m e r i c , format) f o r m a t ) – – ranges, r a n g e s , – – limits, l i m i t s , and a n d – – defaults. d e f a u l t s . interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d other o t h e r SYSTEMS; S Y S T E M S ; software-driven s o f t w a r e - d r i v e n alarms, a l a r m s , warnings, w a r n i n g s , and a n d operator o p e r a t o r messages; m e s s a g e s ; SECURITY S E C U R I T Y requirements; r e q u i r e m e n t s ; NOTE N O T E 3 3 Examples E x a m p l e s include: i n c l u d e : – – those t h o s e related r e l a t e d to t o the t h e compromise c o m p r o m i s e of o f sensitive s e n s i t i v e information, i n f o r m a t i o n , – – authentication, a u t h e n t i c a t i o n , – – authorization, a u t h o r i z a t i o n , – – audit a u d i t trail, t r a i l , and a n d – – communication c o m m u n i c a t i o n integrity, i n t e g r i t y , – – system s y s t e m security/malware s e c u r i t y / m a l w a r e protection. p r o t e c t i o n . user u s e r interface i n t e r f a c e requirements r e q u i r e m e n t s implemented i m p l e m e n t e d by b y software; s o f t w a r e ; NOTE N O T E 4 4 Examples E x a m p l e s include i n c l u d e those t h o s e related r e l a t e d to: t o : – – support s u p p o r t for f o r manual m a n u a l operations, o p e r a t i o n s , – – human-equipment h u m a n - e q u i p m e n t interactions, i n t e r a c t i o n s , – – constraints c o n s t r a i n t s on o n personnel, p e r s o n n e l , and a n d – – areas a r e a s needing n e e d i n g concentrated c o n c e n t r a t e d human h u m a n attention. a t t e n t i o n . NOTE N O T E 5 5 Information I n f o r m a t i o n regarding r e g a r d i n g usability u s a b i l i t y engineering e n g i n e e r i n g requirements r e q u i r e m e n t s can c a n be b e found f o u n d in i n IEC I E C 62366-1 6 2 3 6 6 - 1 [21] [ 2 1 ] among a m o n g others o t h e r s (e.g., ( e . g . , IEC I E C 60601-1-6 6 0 6 0 1 - 1 - 6 [3]). [ 3 ] ) . data d a t a definition d e f i n i t i o n and a n d database d a t a b a s e requirements; r e q u i r e m e n t s ; NOTE N O T E 6 6 Examples E x a m p l e s include: i n c l u d e : – – form; f o r m ; – – fit; f i t ; – – function. f u n c t i o n . installation i n s t a l l a t i o n and a n d acceptance a c c e p t a n c e requirements r e q u i r e m e n t s of o f the t h e delivered d e l i v e r e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E at a t the t h e operation o p e r a t i o n and a n d maintenance m a i n t e n a n c e site s i t e or o r sites; s i t e s ; Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} requirements r e q u i r e m e n t s related r e l a t e d to t o methods m e t h o d s of o f operation o p e r a t i o n and a n d maintenance; m a i n t e n a n c e ; requirements r e q u i r e m e n t s related r e l a t e d to t o IT-network I T - n e t w o r k aspects; a s p e c t s ; NOTE N O T E 9 9 Examples E x a m p l e s include i n c l u d e those t h o s e related r e l a t e d to: t o : – – networked n e t w o r k e d alarms, a l a r m s , warnings, w a r n i n g s , and a n d operator o p e r a t o r messages; m e s s a g e s ; – – network n e t w o r k protocols; p r o t o c o l s ; – – handling h a n d l i n g of o f unavailability u n a v a i l a b i l i t y of o f network n e t w o r k services. s e r v i c e s . user u s e r maintenance m a i n t e n a n c e requirements; r e q u i r e m e n t s ; and a n d regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . NOTE N O T E 10 1 0 The T h e requirements r e q u i r e m e n t s in i n a) a ) through t h r o u g h l) l ) can c a n overlap. o v e r l a p . – – 22 2 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 7 7 All A l l of o f these t h e s e requirements r e q u i r e m e n t s might m i g h t not n o t be b e available a v a i l a b l e at a t the t h e beginning b e g i n n i n g of o f the t h e software s o f t w a r e development. d e v e l o p m e n t . NOTE N O T E 8 8 Among A m o n g others, o t h e r s , ISO/IEC I S O / I E C 25010 2 5 0 1 0 [12] [ 1 2 ] provides p r o v i d e s information i n f o r m a t i o n on o n quality q u a l i t y characteristics c h a r a c t e r i s t i c s that t h a t may m a y be b e useful u s e f u l in i n defining d e f i n i n g software s o f t w a r e requirements. r e q u i r e m e n t s . 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e in i n the t h e requirements r e q u i r e m e n t s as a s appropriate a p p r o p r i a t e to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . [Class [ C l a s s B, B , C] C ] NOTE N O T E These T h e s e requirements r e q u i r e m e n t s might m i g h t not n o t be b e available a v a i l a b l e at a t the t h e beginning b e g i n n i n g of o f the t h e software s o f t w a r e development d e v e l o p m e n t and a n d can c a n change c h a n g e as a s the t h e software s o f t w a r e is i s designed d e s i g n e d and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s are a r e further f u r t h e r defined. d e f i n e d . 5.2.4 5 . 2 . 4 Re-EVALUATE R e - E V A L U A T E MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l re-EVALUATE r e - E V A L U A T E the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S when w h e n software s o f t w a r e requirements r e q u i r e m e n t s are a r e established e s t a b l i s h e d and a n d update u p d a t e it i t as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] 5.2.5 5 . 2 . 5 Update U p d a t e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t existing e x i s t i n g requirements, r e q u i r e m e n t s , including i n c l u d i n g SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , are a r e re- r e - EVALUATED E V A L U A T E D and a n d updated u p d a t e d as a s appropriate a p p r o p r i a t e as a s a a result r e s u l t of o f the t h e software s o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY. A C T I V I T Y . [Class [ C l a s s A, A , B, B , C] C ] 5.2.6 5 . 2 . 6 Verify V e r i f y software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that t h a t the t h e software s o f t w a r e requirements: r e q u i r e m e n t s : implement i m p l e m e n t SYSTEM S Y S T E M requirements r e q u i r e m e n t s including i n c l u d i n g those t h o s e relating r e l a t i n g to t o RISK R I S K CONTROL; C O N T R O L ; do d o not n o t contradict c o n t r a d i c t one o n e another; a n o t h e r ; are a r e expressed e x p r e s s e d in i n terms t e r m s that t h a t avoid a v o i d ambiguity; a m b i g u i t y ; are a r e stated s t a t e d in i n terms t e r m s that t h a t permit p e r m i t establishment e s t a b l i s h m e n t of o f test t e s t criteria c r i t e r i a and a n d performance p e r f o r m a n c e of o f tests; t e s t s ; can c a n be b e uniquely u n i q u e l y identified; i d e n t i f i e d ; and a n d are a r e traceable t r a c e a b l e to t o SYSTEM S Y S T E M requirements r e q u i r e m e n t s or o r other o t h e r source. s o u r c e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e the t h e use u s e of o f a a formal f o r m a l specification s p e c i f i c a t i o n language. l a n g u a g e . 5.3 5 . 3 * * Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.1 5 . 3 . 1 Transform T r a n s f o r m software s o f t w a r e requirements r e q u i r e m e n t s into i n t o an a n ARCHITECTURE A R C H I T E C T U R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l transform t r a n s f o r m the t h e requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E into i n t o a a documented d o c u m e n t e d ARCHITECTURE A R C H I T E C T U R E that t h a t describes d e s c r i b e s the t h e software’s s o f t w a r e ’ s structure s t r u c t u r e and a n d identifies i d e n t i f i e s the t h e SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 23 2 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.3.2 5 . 3 . 2 Develop D e v e l o p an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s of o f SOFTWARE S O F T W A R E ITEMS I T E M S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l develop d e v e l o p and a n d document d o c u m e n t an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d the t h e components c o m p o n e n t s external e x t e r n a l to t o the t h e SOFTWARE S O F T W A R E ITEMS I T E M S (both ( b o t h software s o f t w a r e and a n d hardware), h a r d w a r e ) , and a n d between b e t w e e n the t h e SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s B, B , C] C ] 5.3.3 5 . 3 . 3 Specify S p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s of o f SOUP S O U P item i t e m If I f a a SOFTWARE S O F T W A R E ITEM I T E M is i s identified i d e n t i f i e d as a s SOUP, S O U P , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l specify s p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s for f o r the t h e SOUP S O U P item i t e m that t h a t are a r e necessary n e c e s s a r y for f o r its i t s intended i n t e n d e d use. u s e . [Class [ C l a s s B, B , C] C ] 5.3.4 5 . 3 . 4 Specify S p e c i f y SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e required r e q u i r e d by b y SOUP S O U P item i t e m If I f a a SOFTWARE S O F T W A R E ITEM I T E M is i s identified i d e n t i f i e d as a s SOUP, S O U P , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l specify s p e c i f y the t h e SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e necessary n e c e s s a r y to t o support s u p p o r t the t h e proper p r o p e r operation o p e r a t i o n of o f the t h e SOUP S O U P item. i t e m . [Class [ C l a s s B, B , C] C ] NOTE N O T E Examples E x a m p l e s include i n c l u d e processor p r o c e s s o r type t y p e and a n d speed, s p e e d , memory m e m o r y type t y p e and a n d size, s i z e , SYSTEM S Y S T E M software s o f t w a r e type, t y p e , communication c o m m u n i c a t i o n and a n d display d i s p l a y software s o f t w a r e requirements. r e q u i r e m e n t s . 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y any a n y segregation s e g r e g a t i o n between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t is i s necessary n e c e s s a r y for f o r RISK R I S K CONTROL, C O N T R O L , and a n d state s t a t e how h o w to t o ensure e n s u r e that t h a t such s u c h segregation s e g r e g a t i o n is i s effective. e f f e c t i v e . [Class [ C l a s s C] C ] NOTE N O T E An A n example e x a m p l e of o f segregation s e g r e g a t i o n is i s to t o have h a v e SOFTWARE S O F T W A R E ITEMS I T E M S execute e x e c u t e on o n different d i f f e r e n t processors. p r o c e s s o r s . The T h e effectiveness e f f e c t i v e n e s s of o f the t h e segregation s e g r e g a t i o n can c a n be b e ensured e n s u r e d by b y having h a v i n g no n o shared s h a r e d resources r e s o u r c e s between b e t w e e n the t h e processors. p r o c e s s o r s . Other O t h e r means m e a n s of o f segregation s e g r e g a t i o n can c a n be b e applied a p p l i e d when w h e n effectiveness e f f e c t i v e n e s s can c a n be b e ensured e n s u r e d by b y the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E design d e s i g n (see ( s e e B.4.3). B . 4 . 3 ) . 5.3.6 5 . 3 . 6 Verify V e r i f y software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that: t h a t : the t h e ARCHITECTURE A R C H I T E C T U R E of o f the t h e software s o f t w a r e implements i m p l e m e n t s SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s including i n c l u d i n g those t h o s e relating r e l a t i n g to t o RISK R I S K CONTROL; C O N T R O L ; the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s able a b l e to t o support s u p p o r t interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S and a n d between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S and a n d hardware; h a r d w a r e ; and a n d the t h e MEDICAL M E D I C A L DEVICE D E V I C E ARCHITECTURE A R C H I T E C T U R E supports s u p p o r t s proper p r o p e r operation o p e r a t i o n of o f any a n y SOUP S O U P items. i t e m s . [Class [ C l a s s B, B , C] C ] NOTE N O T E A A TRACEABILITY T R A C E A B I L I T Y analysis a n a l y s i s of o f ARCHITECTURE A R C H I T E C T U R E to t o software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e used u s e d to t o satisfy s a t i s f y requirement r e q u i r e m e n t a). a ) . 5.4 5 . 4 * * Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.1 5 . 4 . 1 Subdivide S u b d i v i d e software s o f t w a r e into i n t o SOFTWARE S O F T W A R E UNITS U N I T S Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l subdvide s u b d v i d e the t h e software s o f t w a r e until u n t i l it i t is i s represented r e p r e s e n t e d by b y SOFTWARE S O F T W A R E UNITS. U N I T S . [Class [ C l a s s B, B , C] C ] NOTE N O T E Some S o m e SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S are a r e not n o t divided d i v i d e d further. f u r t h e r . 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t a a design d e s i g n with w i t h enough e n o u g h detail d e t a i l to t o allow a l l o w correct c o r r e c t implementation i m p l e m e n t a t i o n of o f each e a c h SOFTWARE S O F T W A R E UNIT. U N I T . [Class [ C l a s s C] C ] 5.4.3 5 . 4 . 3 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r interfaces i n t e r f a c e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t a a design d e s i g n for f o r any a n y interfaces i n t e r f a c e s between b e t w e e n the t h e SOFTWARE S O F T W A R E UNIT U N I T and a n d external e x t e r n a l components c o m p o n e n t s (hardware ( h a r d w a r e or o r software), s o f t w a r e ) , as a s well w e l l as a s any a n y interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E UNITS, U N I T S , detailed d e t a i l e d enough e n o u g h to t o implement i m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T and a n d its i t s interfaces i n t e r f a c e s correctly. c o r r e c t l y . [Class [ C l a s s C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 5.4.4 5 . 4 . 4 Verify V e r i f y detailed d e t a i l e d design d e s i g n – – 24 2 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y and a n d document d o c u m e n t that t h a t the t h e software s o f t w a r e detailed d e t a i l e d design: d e s i g n : implements i m p l e m e n t s the t h e software s o f t w a r e ARCHITECTURE; A R C H I T E C T U R E ; and a n d is i s free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . [Class [ C l a s s C] C ] NOTE N O T E It I t is i s acceptable a c c e p t a b l e to t o use u s e a a TRACEABILITY T R A C E A B I L I T Y analysis a n a l y s i s of o f ARCHITECTURE A R C H I T E C T U R E to t o software s o f t w a r e detailed d e t a i l e d design d e s i g n to t o satisfy s a t i s f y requirement r e q u i r e m e n t a). a ) . 5.5 5 . 5 * * SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n 5.5.1 5 . 5 . 1 Implement I m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l implement i m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT. U N I T . [Class [ C l a s s A, A , B, B , C] C ] 5.5.2 5 . 5 . 2 Establish E s t a b l i s h SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h strategies, s t r a t e g i e s , methods m e t h o d s and a n d procedures p r o c e d u r e s for f o r verifying v e r i f y i n g the t h e SOFTWARE S O F T W A R E UNITS. U N I T S . Where W h e r e VERIFICATION V E R I F I C A T I O N is i s done d o n e by b y testing, t e s t i n g , the t h e test t e s t procedures p r o c e d u r e s shall s h a l l be b e EVALUATED E V A L U A T E D for f o r adequacy. a d e q u a c y . [Class [ C l a s s B, B , C] C ] NOTE N O T E It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . 5.5.3 5 . 5 . 3 SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h acceptance a c c e p t a n c e criteria c r i t e r i a for f o r SOFTWARE S O F T W A R E UNITS U N I T S prior p r i o r to t o integration i n t e g r a t i o n into i n t o larger l a r g e r SOFTWARE S O F T W A R E ITEMS I T E M S as a s appropriate, a p p r o p r i a t e , and a n d ensure e n s u r e that t h a t SOFTWARE S O F T W A R E UNITS U N I T S meet m e e t acceptance a c c e p t a n c e criteria. c r i t e r i a . [Class [ C l a s s B, B , C] C ] NOTE N O T E Examples E x a m p l e s of o f acceptance a c c e p t a n c e criteria c r i t e r i a are: a r e : – – does d o e s the t h e software s o f t w a r e code c o d e implement i m p l e m e n t requirements r e q u i r e m e n t s including i n c l u d i n g RISK R I S K CONTROL C O N T R O L measures? m e a s u r e s ? – – is i s the t h e software s o f t w a r e code c o d e free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e interface i n t e r f a c e design d e s i g n of o f the t h e SOFTWARE S O F T W A R E UNIT? U N I T ? – – does d o e s the t h e software s o f t w a r e code c o d e conform c o n f o r m to t o programming p r o g r a m m i n g procedures p r o c e d u r e s or o r coding c o d i n g standards? s t a n d a r d s ? 5.5.4 5 . 5 . 4 Additional A d d i t i o n a l SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a When W h e n present p r e s e n t in i n the t h e design, d e s i g n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e additional a d d i t i o n a l acceptance a c c e p t a n c e criteria c r i t e r i a as a s appropriate a p p r o p r i a t e for: f o r : proper p r o p e r event e v e n t sequence; s e q u e n c e ; data d a t a and a n d control c o n t r o l flow; f l o w ; planned p l a n n e d resource r e s o u r c e allocation; a l l o c a t i o n ; fault f a u l t handling h a n d l i n g (error ( e r r o r definition, d e f i n i t i o n , isolation, i s o l a t i o n , and a n d recovery); r e c o v e r y ) ; initialisation i n i t i a l i s a t i o n of o f variables; v a r i a b l e s ; self-diagnostics; s e l f - d i a g n o s t i c s ; memory m e m o r y management m a n a g e m e n t and a n d memory m e m o r y overflows; o v e r f l o w s ; and a n d boundary b o u n d a r y conditions. c o n d i t i o n s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s C] C ] 5.5.5 5 . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m the t h e SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N and a n d document d o c u m e n t the t h e results. r e s u l t s . [Class [ C l a s s B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 25 2 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.6 5 . 6 * * Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.6.1 5 . 6 . 1 Integrate I n t e g r a t e SOFTWARE S O F T W A R E UNITS U N I T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l integrate i n t e g r a t e the t h e SOFTWARE S O F T W A R E UNITS U N I T S in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5). 5 . 1 . 5 ) . [Class [ C l a s s B, B , C] C ] 5.6.2 5 . 6 . 2 Verify V e r i f y software s o f t w a r e integration i n t e g r a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y that t h a t the t h e SOFTWARE S O F T W A R E UNITS U N I T S have h a v e been b e e n integrated i n t e g r a t e d into i n t o SOFTWARE S O F T W A R E ITEMS I T E M S and/or a n d / o r the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5) 5 . 1 . 5 ) and a n d retain r e t a i n records r e c o r d s of o f the t h e evidence e v i d e n c e of o f such s u c h verification. v e r i f i c a t i o n . [Class [ C l a s s B, B , C] C ] NOTE N O T E This T h i s VERIFICATION V E R I F I C A T I O N is i s only o n l y that t h a t the t h e integration i n t e g r a t i o n has h a s been b e e n done d o n e according a c c o r d i n g to t o the t h e plan. p l a n . This T h i s VERIFICATION V E R I F I C A T I O N is i s most m o s t likely l i k e l y implemented i m p l e m e n t e d by b y some s o m e form f o r m of o f inspection. i n s p e c t i o n . 5.6.3 5 . 6 . 3 Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l test t e s t the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS I T E M S in i n accordance a c c o r d a n c e with w i t h the t h e integration i n t e g r a t i o n plan p l a n (see ( s e e 5.1.5) 5 . 1 . 5 ) and a n d document d o c u m e n t the t h e results. r e s u l t s . [Class [ C l a s s B, B , C] C ] 5.6.4 5 . 6 . 4 Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g content c o n t e n t For F o r software s o f t w a r e integration i n t e g r a t i o n testing, t e s t i n g , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l address a d d r e s s whether w h e t h e r the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEM I T E M performs p e r f o r m s as a s intended. i n t e n d e d . [Class [ C l a s s B, B , C] C ] NOTE N O T E 1 1 Examples E x a m p l e s to t o be b e considered c o n s i d e r e d are: a r e : - - the t h e required r e q u i r e d functionality f u n c t i o n a l i t y of o f the t h e software; s o f t w a r e ; - - implementation i m p l e m e n t a t i o n of o f RISK R I S K CONTROL C O N T R O L measures; m e a s u r e s ; - - specified s p e c i f i e d timing t i m i n g and a n d other o t h e r behaviour; b e h a v i o u r ; - - specified s p e c i f i e d functioning f u n c t i o n i n g of o f internal i n t e r n a l and a n d external e x t e r n a l interfaces; i n t e r f a c e s ; and a n d - - testing t e s t i n g under u n d e r abnormal a b n o r m a l conditions c o n d i t i o n s including i n c l u d i n g foreseeable f o r e s e e a b l e misuse. m i s u s e . NOTE N O T E 2 2 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . 5.6.5 5 . 6 . 5 EVALUATE E V A L U A T E software s o f t w a r e integration i n t e g r a t i o n test t e s t procedures p r o c e d u r e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e integration i n t e g r a t i o n test t e s t procedures p r o c e d u r e s for f o r adequacy. a d e q u a c y . [Class [ C l a s s B, B , C] C ] 5.6.6 5 . 6 . 6 Conduct C o n d u c t regression r e g r e s s i o n tests t e s t s When W h e n software s o f t w a r e items i t e m s are a r e integrated, i n t e g r a t e d , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l conduct c o n d u c t REGRESSION R E G R E S S I O N TESTING T E S T I N G appropriate a p p r o p r i a t e to t o demonstrate d e m o n s t r a t e that t h a t defects d e f e c t s have h a v e not n o t been b e e n introduced i n t r o d u c e d into i n t o previously p r e v i o u s l y integrated i n t e g r a t e d software. s o f t w a r e . [Class [ C l a s s B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.6.7 5 . 6 . 7 Integration I n t e g r a t i o n test t e s t record r e c o r d contents c o n t e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : document d o c u m e n t the t h e test t e s t result r e s u l t (pass/fail ( p a s s / f a i l and a n d a a list l i s t of o f ANOMALIES); A N O M A L I E S ) ; retain r e t a i n sufficient s u f f i c i e n t records r e c o r d s to t o permit p e r m i t the t h e test t e s t to t o be b e repeated; r e p e a t e d ; and a n d identify i d e n t i f y the t h e tester. t e s t e r . [Class [ C l a s s B, B , C] C ] NOTE N O T E Requirement R e q u i r e m e n t b) b ) could c o u l d be b e implemented i m p l e m e n t e d by b y retaining, r e t a i n i n g , for f o r example: e x a m p l e : - - test t e s t case c a s e specifications s p e c i f i c a t i o n s showing s h o w i n g required r e q u i r e d actions a c t i o n s and a n d expected e x p e c t e d results; r e s u l t s ; granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} - - records r e c o r d s of o f the t h e equipment; e q u i p m e n t ; - - records r e c o r d s of o f the t h e test t e s t environment e n v i r o n m e n t (including ( i n c l u d i n g software s o f t w a r e tools) t o o l s ) used u s e d for f o r test. t e s t . – – 26 2 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 5.6.8 5 . 6 . 8 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l enter e n t e r ANOMALIES A N O M A L I E S found f o u n d during d u r i n g software s o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g into i n t o a a software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e Clause C l a u s e 9. 9 . 5.7 5 . 7 * * SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 5.7.1 5 . 7 . 1 Establish E s t a b l i s h tests t e s t s for f o r software s o f t w a r e requirements r e q u i r e m e n t s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h and a n d perform p e r f o r m a a set s e t of o f tests, t e s t s , expressed e x p r e s s e d as a s input i n p u t stimuli, s t i m u l i , expected e x p e c t e d outcomes, o u t c o m e s , pass/fail p a s s / f a i l criteria c r i t e r i a and a n d procedures, p r o c e d u r e s , for f o r conducting c o n d u c t i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , such s u c h that t h a t all a l l software s o f t w a r e requirements r e q u i r e m e n t s are a r e covered. c o v e r e d . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 1 1 It I t is i s acceptable a c c e p t a b l e to t o combine c o m b i n e integration i n t e g r a t i o n testing t e s t i n g and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g into i n t o a a single s i n g l e plan p l a n and a n d set s e t of o f ACTIVITIES. A C T I V I T I E S . It I t is i s also a l s o acceptable a c c e p t a b l e to t o test t e s t software s o f t w a r e requirements r e q u i r e m e n t s in i n earlier e a r l i e r phases. p h a s e s . NOTE N O T E 2 2 Not N o t only o n l y separate s e p a r a t e tests t e s t s for f o r each e a c h requirement, r e q u i r e m e n t , but b u t also a l s o tests t e s t s of o f combinations c o m b i n a t i o n s of o f requirements r e q u i r e m e n t s can c a n be b e performed, p e r f o r m e d , especially e s p e c i a l l y if i f dependencies d e p e n d e n c i e s between b e t w e e n requirements r e q u i r e m e n t s exist. e x i s t . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e adequacy a d e q u a c y of o f VERIFICATION V E R I F I C A T I O N strategies s t r a t e g i e s and a n d test t e s t procedures. p r o c e d u r e s . 5.7.2 5 . 7 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l enter e n t e r ANOMALIES A N O M A L I E S found f o u n d during d u r i n g software s o f t w a r e system s y s t e m testing t e s t i n g into i n t o a a software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . [Class [ C l a s s A, A , B, B , C] C ] 5.7.3 5 . 7 . 3 Retest R e t e s t after a f t e r changes c h a n g e s When W h e n changes c h a n g e s are a r e made m a d e during d u r i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : repeat r e p e a t tests, t e s t s , perform p e r f o r m modified m o d i f i e d tests t e s t s or o r perform p e r f o r m additional a d d i t i o n a l tests, t e s t s , as a s appropriate, a p p r o p r i a t e , to t o verify v e r i f y the t h e effectiveness e f f e c t i v e n e s s of o f the t h e change c h a n g e in i n correcting c o r r e c t i n g the t h e problem; p r o b l e m ; conduct c o n d u c t testing t e s t i n g appropriate a p p r o p r i a t e to t o demonstrate d e m o n s t r a t e that t h a t unintended u n i n t e n d e d side s i d e effects e f f e c t s have h a v e not n o t been b e e n introduced; i n t r o d u c e d ; and a n d perform p e r f o r m relevant r e l e v a n t RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S as a s defined d e f i n e d in i n 7.4. 7 . 4 . [Class [ C l a s s A, A , B, B , C] C ] 5.7.4 5 . 7 . 4 Evaluate E v a l u a t e SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E the t h e appropriateness a p p r o p r i a t e n e s s of o f VERIFICATION V E R I F I C A T I O N strategies s t r a t e g i e s and a n d test t e s t procedures. p r o c e d u r e s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y that: t h a t : all a l l software s o f t w a r e requirements r e q u i r e m e n t s have h a v e been b e e n tested t e s t e d or o r otherwise o t h e r w i s e VERIFIED; V E R I F I E D ; the t h e TRACEABILITY T R A C E A B I L I T Y between b e t w e e n software s o f t w a r e requirements r e q u i r e m e n t s and a n d tests t e s t s or o r other o t h e r VERIFICATION V E R I F I C A T I O N is i s recorded; r e c o r d e d ; and a n d test t e s t results r e s u l t s meet m e e t the t h e required r e q u i r e d pass/fail p a s s / f a i l criteria. c r i t e r i a . [Class [ C l a s s A, A , B, B , C] C ] 5.7.5 5 . 7 . 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t record r e c o r d contents c o n t e n t s In I n order o r d e r to t o support s u p p o r t the t h e repeatability r e p e a t a b i l i t y of o f tests, t e s t s , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document: d o c u m e n t : granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 27 2 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 a a reference r e f e r e n c e to t o test t e s t case c a s e procedures p r o c e d u r e s showing s h o w i n g required r e q u i r e d actions a c t i o n s and a n d expected e x p e c t e d results; r e s u l t s ; the t h e test t e s t result r e s u l t (pass/fail ( p a s s / f a i l and a n d a a list l i s t of o f ANOMALIES); A N O M A L I E S ) ; the t h e version v e r s i o n of o f software s o f t w a r e tested; t e s t e d ; relevant r e l e v a n t hardware h a r d w a r e and a n d software s o f t w a r e test t e s t configurations; c o n f i g u r a t i o n s ; relevant r e l e v a n t test t e s t tools; t o o l s ; date d a t e tested; t e s t e d ; and a n d the t h e identity i d e n t i t y of o f the t h e person p e r s o n responsible r e s p o n s i b l e for f o r executing e x e c u t i n g the t h e test t e s t and a n d recording r e c o r d i n g the t h e test t e s t results. r e s u l t s . [Class [ C l a s s A, A , B, B , C] C ] 5.8 5 . 8 * * Software S o f t w a r e RELEASE R E L E A S E for f o r utilization u t i l i z a t i o n at a t a a SYSTEM S Y S T E M level l e v e l 5.8.1 5 . 8 . 1 Ensure E n s u r e software s o f t w a r e VERIFICATION V E R I F I C A T I O N is i s complete c o m p l e t e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l software s o f t w a r e VERIFICATION V E R I F I C A T I O N ACTIVITIES A C T I V I T I E S have h a v e been b e e n completed c o m p l e t e d and a n d the t h e results r e s u l t s have h a v e been b e e n EVALUATED E V A L U A T E D before b e f o r e the t h e software s o f t w a r e is i s released. r e l e a s e d . [Class [ C l a s s A, A , B, B , C] C ] 5.8.2 5 . 8 . 2 Document D o c u m e n t known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t all a l l known k n o w n residual r e s i d u a l ANOMALIES. A N O M A L I E S . [Class [ C l a s s A, A , B, B , C] C ] 5.8.3 5 . 8 . 3 EVALUATE E V A L U A T E known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S have h a v e been b e e n EVALUATED E V A L U A T E D to t o ensure e n s u r e that t h a t they t h e y do d o not n o t contribute c o n t r i b u t e to t o an a n unacceptable u n a c c e p t a b l e RISK. R I S K . [Class [ C l a s s B, B , C] C ] 5.8.4 5 . 8 . 4 Document D o c u m e n t released r e l e a s e d VERSIONS V E R S I O N S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t is i s being b e i n g released. r e l e a s e d . [Class [ C l a s s A, A , B, B , C] C ] 5.8.5 5 . 8 . 5 Document D o c u m e n t how h o w released r e l e a s e d software s o f t w a r e was w a s created c r e a t e d The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e procedure p r o c e d u r e and a n d environment e n v i r o n m e n t used u s e d to t o create c r e a t e the t h e released r e l e a s e d software. s o f t w a r e . [Class [ C l a s s B, B , C] C ] 5.8.6 5 . 8 . 6 Ensure E n s u r e activities a c t i v i t i e s and a n d tasks t a s k s are a r e complete c o m p l e t e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l ensure e n s u r e that t h a t all a l l software s o f t w a r e development d e v e l o p m e n t plan p l a n (or ( o r maintenance m a i n t e n a n c e plan) p l a n ) ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S are a r e complete c o m p l e t e along a l o n g with w i t h the t h e associated a s s o c i a t e d documentation. d o c u m e n t a t i o n . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e 5.1.3.b). 5 . 1 . 3 . b ) . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 5.8.7 5 . 8 . 7 Archive A r c h i v e software s o f t w a r e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l archive: a r c h i v e : the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d CONFIGURATION C O N F I G U R A T I O N ITEMS; I T E M S ; and a n d the t h e documentation d o c u m e n t a t i o n for f o r at a t least l e a s t a a period p e r i o d of o f time t i m e determined d e t e r m i n e d as a s the t h e longer l o n g e r of: o f : the t h e life l i f e time t i m e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E as a s defined d e f i n e d by b y the t h e MANUFACTURER M A N U F A C T U R E R or o r a a time t i m e specified s p e c i f i e d by b y relevant r e l e v a n t regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . [Class [ C l a s s A, A , B, B , C] C ] 5.8.8 5 . 8 . 8 Assure A s s u r e reliable r e l i a b l e delivery d e l i v e r y of o f released r e l e a s e d software s o f t w a r e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h procedures p r o c e d u r e s to t o ensure e n s u r e that t h a t the t h e released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E can c a n be b e reliably r e l i a b l y delivered d e l i v e r e d to t o the t h e point p o i n t of o f use u s e without w i t h o u t corruption c o r r u p t i o n or o r unauthorised u n a u t h o r i s e d granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 28 2 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 change. c h a n g e . These T h e s e procedures p r o c e d u r e s shall s h a l l address a d d r e s s the t h e production p r o d u c t i o n and a n d handling h a n d l i n g of o f media m e d i a containing c o n t a i n i n g the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E including i n c l u d i n g as a s appropriate: a p p r o p r i a t e : – – replication, r e p l i c a t i o n , – – media m e d i a labelling, l a b e l l i n g , – – packaging, p a c k a g i n g , – – protection, p r o t e c t i o n , – – storage, s t o r a g e , and a n d – – delivery. d e l i v e r y . [Class [ C l a s s A, A , B, B , C] C ] 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S 6.1 6 . 1 * * Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n (or ( o r plans) p l a n s ) for f o r conducting c o n d u c t i n g the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e maintenance m a i n t e n a n c e PROCESS. P R O C E S S . The T h e plan p l a n shall s h a l l address a d d r e s s the t h e following: f o l l o w i n g : procedures p r o c e d u r e s for: f o r : – – receiving, r e c e i v i n g , – – documenting, d o c u m e n t i n g , – – evaluating, e v a l u a t i n g , – – resolving r e s o l v i n g and a n d – – tracking t r a c k i n g feedback f e e d b a c k arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE; S O F T W A R E ; criteria c r i t e r i a for f o r determining d e t e r m i n i n g whether w h e t h e r feedback f e e d b a c k is i s considered c o n s i d e r e d to t o be b e a a problem; p r o b l e m ; use u s e of o f the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS; P R O C E S S ; use u s e of o f the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S for f o r analysing a n a l y s i n g and a n d resolving r e s o l v i n g problems p r o b l e m s arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE; S O F T W A R E ; use u s e of o f the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) for f o r managing m a n a g i n g modifications m o d i f i c a t i o n s to t o the t h e existing e x i s t i n g SOFTWARE S O F T W A R E SYSTEM; S Y S T E M ; and a n d procedures p r o c e d u r e s to t o EVALUATE E V A L U A T E and a n d implement: i m p l e m e n t : – – upgrades, u p g r a d e s , – – bug b u g fixes, f i x e s , – – patches p a t c h e s and a n d – – obsolescence o b s o l e s c e n c e of o f SOUP. S O U P . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] 6.2 6 . 2 * * Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.2.1 6 . 2 . 1 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k 6.2.1.1 6 . 2 . 1 . 1 Monitor M o n i t o r feedback f e e d b a c k The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l monitor m o n i t o r feedback f e e d b a c k on o n MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E released r e l e a s e d for f o r intended i n t e n d e d use. u s e . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 29 2 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 6.2.1.2 6 . 2 . 1 . 2 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k Feedback F e e d b a c k shall s h a l l be b e documented d o c u m e n t e d and a n d EVALUATED E V A L U A T E D to t o determine d e t e r m i n e whether w h e t h e r a a problem p r o b l e m exists e x i s t s in i n a a released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Any A n y such s u c h problem p r o b l e m shall s h a l l be b e recorded r e c o r d e d as a s a a PROBLEM P R O B L E M REPORT R E P O R T (see ( s e e Clause C l a u s e 9). 9 ) . PROBLEM P R O B L E M REPORTS R E P O R T S shall s h a l l include i n c l u d e actual a c t u a l or o r potential p o t e n t i a l adverse a d v e r s e events, e v e n t s , and a n d deviations d e v i a t i o n s from f r o m specifications. s p e c i f i c a t i o n s . [Class [ C l a s s A, A , B, B , C] C ] 6.2.1.3 6 . 2 . 1 . 3 Evaluate E v a l u a t e PROBLEM P R O B L E M REPORT’S R E P O R T ’ S affects a f f e c t s on o n SAFETY S A F E T Y Each E a c h PROBLEM P R O B L E M REPORT R E P O R T shall s h a l l be b e EVALUATED E V A L U A T E D to t o determine d e t e r m i n e how h o w it i t affects a f f e c t s the t h e SAFETY S A F E T Y of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E released r e l e a s e d for f o r intended i n t e n d e d use u s e (see ( s e e 9.2) 9 . 2 ) and a n d whether w h e t h e r a a change c h a n g e to t o that t h a t software s o f t w a r e is i s needed n e e d e d to t o address a d d r e s s the t h e problem. p r o b l e m . [Class [ C l a s s A, A , B, B , C] C ] 6.2.2 6 . 2 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l use u s e the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S (see ( s e e Clause C l a u s e 9) 9 ) to t o address a d d r e s s PROBLEM P R O B L E M REPORTS. R E P O R T S . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E A A problem p r o b l e m could c o u l d show s h o w that t h a t a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r SOFTWARE S O F T W A R E ITEM I T E M has h a s not n o t been b e e n placed p l a c e d in i n the t h e correct c o r r e c t software s o f t w a r e safety s a f e t y class. c l a s s . The T h e problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s can c a n suggest s u g g e s t changes c h a n g e s of o f the t h e software s o f t w a r e safety s a f e t y class. c l a s s . When W h e n the t h e PROCESS P R O C E S S has h a s been b e e n completed, c o m p l e t e d , any a n y change c h a n g e of o f safety s a f e t y class c l a s s in i n the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r its i t s SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e made m a d e known k n o w n and a n d documented. d o c u m e n t e d . 6.2.3 6 . 2 . 3 Analyse A n a l y s e CHANGE C H A N G E REQUESTS R E Q U E S T S In I n addition a d d i t i o n to t o the t h e analysis a n a l y s i s required r e q u i r e d by b y Clause C l a u s e 9, 9 , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e each e a c h CHANGE C H A N G E REQUEST R E Q U E S T for f o r its i t s effect e f f e c t on o n the t h e organization, o r g a n i z a t i o n , MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E released r e l e a s e d for f o r intended i n t e n d e d use u s e , , and a n d SYSTEMS S Y S T E M S with w i t h which w h i c h it i t interfaces. i n t e r f a c e s . [Class [ C l a s s A, A , B, B , C] C ] 6.2.4 6 . 2 . 4 CHANGE C H A N G E REQUEST R E Q U E S T approval a p p r o v a l The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E and a n d approve a p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S which w h i c h modify m o d i f y released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . [Class [ C l a s s A, A , B, B , C] C ] 6.2.5 6 . 2 . 5 Communicate C o m m u n i c a t e to t o users u s e r s and a n d regulators r e g u l a t o r s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y the t h e approved a p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S that t h a t affect a f f e c t released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . As A s required r e q u i r e d by b y local l o c a l regulation, r e g u l a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l inform i n f o r m users u s e r s and a n d regulators r e g u l a t o r s about: a b o u t : any a n y problem p r o b l e m in i n released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d the t h e consequences c o n s e q u e n c e s of o f continued c o n t i n u e d unchanged u n c h a n g e d use; u s e ; and a n d the t h e nature n a t u r e of o f any a n y available a v a i l a b l e changes c h a n g e s to t o released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d how h o w to t o obtain o b t a i n and a n d install i n s t a l l the t h e changes. c h a n g e s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] 6.3 6 . 3 * * Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 6.3.1 6 . 3 . 1 Use U s e established e s t a b l i s h e d PROCESS P R O C E S S to t o implement i m p l e m e n t modification m o d i f i c a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y and a n d perform p e r f o r m any a n y Clause C l a u s e 5 5 ACTIVITIES A C T I V I T I E S that t h a t need n e e d to t o be b e repeated r e p e a t e d as a s a a result r e s u l t of o f the t h e modification. m o d i f i c a t i o n . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E For F o r requirements r e q u i r e m e n t s relating r e l a t i n g to t o RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s see s e e 7.4. 7 . 4 . 6.3.2 6 . 3 . 2 Re-release R e - r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEM S Y S T E M The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l release r e l e a s e modifications m o d i f i c a t i o n s according a c c o r d i n g to t o 5.8. 5 . 8 . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 30 3 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 NOTE N O T E Modifications M o d i f i c a t i o n s can c a n be b e released r e l e a s e d as a s part p a r t of o f a a full f u l l re-release r e - r e l e a s e of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M or o r as a s a a modification m o d i f i c a t i o n kit k i t comprising c o m p r i s i n g changed c h a n g e d SOFTWARE S O F T W A R E ITEMS I T E M S and a n d the t h e necessary n e c e s s a r y tools t o o l s to t o install i n s t a l l the t h e changes c h a n g e s as a s modifications m o d i f i c a t i o n s to t o an a n existing e x i s t i n g SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . 7 7 * * Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 7.1 7 . 1 * * Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s 7.1.1 7 . 1 . 1 Identify I d e n t i f y SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t could c o u l d contribute c o n t r i b u t e to t o a a hazardous h a z a r d o u s situation s i t u a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y SOFTWARE S O F T W A R E ITEMS I T E M S that t h a t could c o u l d contribute c o n t r i b u t e to t o a a hazardous h a z a r d o u s situation s i t u a t i o n identified i d e n t i f i e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S ACTIVITY A C T I V I T Y of o f ISO I S O 14971 1 4 9 7 1 (see ( s e e 4.2). 4 . 2 ) . [Class [ C l a s s B, B , C] C ] NOTE N O T E The T h e hazardous h a z a r d o u s situation s i t u a t i o n could c o u l d be b e the t h e direct d i r e c t result r e s u l t of o f software s o f t w a r e failure f a i l u r e or o r the t h e result r e s u l t of o f the t h e failure f a i l u r e of o f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e that t h a t is i s implemented i m p l e m e n t e d in i n software. s o f t w a r e . 7.1.2 7 . 1 . 2 Identify I d e n t i f y potential p o t e n t i a l causes c a u s e s of o f contribution c o n t r i b u t i o n to t o a a hazardous h a z a r d o u s situation s i t u a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y potential p o t e n t i a l causes c a u s e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M identified i d e n t i f i e d above a b o v e contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation. s i t u a t i o n . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l consider c o n s i d e r potential p o t e n t i a l causes c a u s e s including, i n c l u d i n g , as a s appropriate: a p p r o p r i a t e : incorrect i n c o r r e c t or o r incomplete i n c o m p l e t e specification s p e c i f i c a t i o n of o f functionality; f u n c t i o n a l i t y ; software s o f t w a r e defects d e f e c t s in i n the t h e identified i d e n t i f i e d SOFTWARE S O F T W A R E ITEM I T E M functionality; f u n c t i o n a l i t y ; failure f a i l u r e or o r unexpected u n e x p e c t e d results r e s u l t s from f r o m SOUP; S O U P ; hardware h a r d w a r e failures f a i l u r e s or o r other o t h e r software s o f t w a r e defects d e f e c t s that t h a t could c o u l d result r e s u l t in i n unpredictable u n p r e d i c t a b l e software s o f t w a r e operation; o p e r a t i o n ; and a n d reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e misuse. m i s u s e . [Class [ C l a s s B, B , C] C ] 7.1.3 7 . 1 . 3 EVALUATE E V A L U A T E published p u b l i s h e d SOUP S O U P ANOMALY A N O M A L Y lists l i s t s If I f failure f a i l u r e or o r unexpected u n e x p e c t e d results r e s u l t s from f r o m SOUP S O U P is i s a a potential p o t e n t i a l cause c a u s e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation, s i t u a t i o n , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l EVALUATE E V A L U A T E as a s a a minimum m i n i m u m any a n y ANOMALY A N O M A L Y list l i s t published p u b l i s h e d by b y the t h e supplier s u p p l i e r of o f the t h e SOUP S O U P item i t e m relevant r e l e v a n t to t o the t h e VERSION V E R S I O N of o f the t h e SOUP S O U P item i t e m used u s e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E to t o determine d e t e r m i n e if i f any a n y of o f the t h e known k n o w n ANOMALIES A N O M A L I E S result r e s u l t in i n a a sequence s e q u e n c e of o f events e v e n t s that t h a t could c o u l d result r e s u l t in i n a a hazardous h a z a r d o u s situation. s i t u a t i o n . [Class [ C l a s s B, B , C] C ] 7.1.4 7 . 1 . 4 Document D o c u m e n t potential p o t e n t i a l causes c a u s e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E potential p o t e n t i a l causes c a u s e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation s i t u a t i o n (see ( s e e ISO I S O 14971). 1 4 9 7 1 ) . [Class [ C l a s s B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.2.1 7 . 2 . 1 Define D e f i n e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s For F o r each e a c h case c a s e documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E where w h e r e a a SOFTWARE S O F T W A R E ITEM I T E M could c o u l d contribute c o n t r i b u t e to t o a a HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l define d e f i n e and a n d document d o c u m e n t RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n accordance a c c o r d a n c e with w i t h ISO I S O 14971. 1 4 9 7 1 . [Class [ C l a s s B, B , C] C ] NOTE N O T E The T h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s can c a n be b e implemented i m p l e m e n t e d in i n hardware, h a r d w a r e , software, s o f t w a r e , the t h e working w o r k i n g environment e n v i r o n m e n t or o r user u s e r instruction. i n s t r u c t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 31 3 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 7.2.2 7 . 2 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e If I f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s implemented i m p l e m e n t e d as a s part p a r t of o f the t h e functions f u n c t i o n s of o f a a SOFTWARE S O F T W A R E ITEM, I T E M , the t h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : include i n c l u d e the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e in i n the t h e software s o f t w a r e requirements; r e q u i r e m e n t s ; assign a s s i g n to t o each e a c h SOFTWARE S O F T W A R E ITEM I T E M that t h a t contributes c o n t r i b u t e s to t o the t h e implementation i m p l e m e n t a t i o n of o f a a RISK R I S K CONTROL C O N T R O L measure m e a s u r e a a software s o f t w a r e safety s a f e t y class c l a s s based b a s e d on o n the t h e RISK R I S K that t h a t the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e is i s controlling c o n t r o l l i n g (see ( s e e 4.3 4 . 3 a)); a ) ) ; and a n d develop d e v e l o p the t h e SOFTWARE S O F T W A R E ITEM I T E M in i n accordance a c c o r d a n c e with w i t h Clause C l a u s e 5. 5 . [Class [ C l a s s B, B , C] C ] NOTE N O T E This T h i s requirement r e q u i r e m e n t provides p r o v i d e s additional a d d i t i o n a l detail d e t a i l for f o r RISK R I S K CONTROL C O N T R O L requirements r e q u i r e m e n t s of o f ISO I S O 14971 1 4 9 7 1 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.3.1 7 . 3 . 1 Verify V e r i f y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s The T h e implementation i m p l e m e n t a t i o n of o f each e a c h RISK R I S K CONTROL C O N T R O L measure m e a s u r e documented d o c u m e n t e d in i n 7.2 7 . 2 shall s h a l l be b e VERIFIED, V E R I F I E D , and a n d this t h i s VERIFICATION V E R I F I C A T I O N shall s h a l l be b e documented. d o c u m e n t e d . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l review r e v i e w the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e and a n d determine d e t e r m i n e if i f it i t could c o u l d result r e s u l t in i n a a new n e w HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . [Class [ C l a s s B, B , C] C ] 7.3.2 7 . 3 . 2 Not N o t used. u s e d . 7.3.3 7 . 3 . 3 Document D o c u m e n t TRACEABILITY T R A C E A B I L I T Y The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t TRACEABILITY T R A C E A B I L I T Y of o f software s o f t w a r e HAZARDS H A Z A R D S as a s appropriate: a p p r o p r i a t e : from f r o m the t h e hazardous h a z a r d o u s situation s i t u a t i o n to t o the t h e SOFTWARE S O F T W A R E ITEM; I T E M ; from f r o m the t h e SOFTWARE S O F T W A R E ITEM I T E M to t o the t h e specific s p e c i f i c software s o f t w a r e cause; c a u s e ; from f r o m the t h e software s o f t w a r e cause c a u s e to t o the t h e RISK R I S K CONTROL C O N T R O L measure; m e a s u r e ; and a n d from f r o m the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e to t o the t h e VERIFICATION V E R I F I C A T I O N of o f the t h e RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . [Class [ C l a s s B, B , C] C ] NOTE N O T E See S e e ISO I S O 14971 1 4 9 7 1 – – RISK R I S K MANAGEMENT M A N A G E M E N T report. r e p o r t . 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s 7.4.1 7 . 4 . 1 Analyse A n a l y s e changes c h a n g e s to t o MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E with w i t h respect r e s p e c t to t o SAFETY S A F E T Y The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e changes c h a n g e s to t o the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E (including ( i n c l u d i n g SOUP) S O U P ) to t o determine d e t e r m i n e whether: w h e t h e r : additional a d d i t i o n a l potential p o t e n t i a l causes c a u s e s are a r e introduced i n t r o d u c e d contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation; s i t u a t i o n ; and a n d additional a d d i t i o n a l software s o f t w a r e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s are a r e required. r e q u i r e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . [Class [ C l a s s A, A , B, B , C] C ] 7.4.2 7 . 4 . 2 Analyse A n a l y s e impact i m p a c t of o f software s o f t w a r e changes c h a n g e s on o n existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l analyse a n a l y s e changes c h a n g e s to t o the t h e software, s o f t w a r e , including i n c l u d i n g changes c h a n g e s to t o SOUP, S O U P , to t o determine d e t e r m i n e whether w h e t h e r the t h e software s o f t w a r e modification m o d i f i c a t i o n could c o u l d interfere i n t e r f e r e with w i t h existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . [Class [ C l a s s B, B , C] C ] 7.4.3 7 . 4 . 3 Perform P e r f o r m RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S based b a s e d on o n analyses a n a l y s e s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 32 3 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m relevant r e l e v a n t RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n 7.1, 7 . 1 , 7.2 7 . 2 and a n d 7.3 7 . 3 based b a s e d on o n these t h e s e analyses. a n a l y s e s . [Class [ C l a s s B, B , C] C ] 8 8 * * Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S 8.1 8 . 1 * * Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 8.1.1 8 . 1 . 1 Establish E s t a b l i s h means m e a n s to t o identify i d e n t i f y CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l establish e s t a b l i s h a a scheme s c h e m e for f o r the t h e unique u n i q u e identification i d e n t i f i c a t i o n of o f CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS V E R S I O N S to t o be b e controlled c o n t r o l l e d according a c c o r d i n g to t o the t h e development d e v e l o p m e n t and a n d configuration c o n f i g u r a t i o n planning p l a n n i n g specified s p e c i f i e d in i n 5.1. 5 . 1 . [Class [ C l a s s A, A , B, B , C] C ] 8.1.2 8 . 1 . 2 Identify I d e n t i f y SOUP S O U P For F o r each e a c h SOUP S O U P CONFIGURATION C O N F I G U R A T I O N ITEM I T E M being b e i n g used, u s e d , including i n c l u d i n g standard s t a n d a r d libraries, l i b r a r i e s , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document: d o c u m e n t : the t h e title, t i t l e , the t h e MANUFACTURER, M A N U F A C T U R E R , and a n d the t h e unique u n i q u e SOUP S O U P designator d e s i g n a t o r [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E The T h e unique u n i q u e SOUP S O U P designator d e s i g n a t o r could c o u l d be, b e , for f o r example, e x a m p l e , a a VERSION, V E R S I O N , a a release r e l e a s e date, d a t e , a a patch p a t c h number n u m b e r or o r an a n upgrade u p g r a d e designation. d e s i g n a t i o n . 8.1.3 8 . 1 . 3 Identify I d e n t i f y SYSTEM S Y S T E M configuration c o n f i g u r a t i o n documentation d o c u m e n t a t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e set s e t of o f CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS V E R S I O N S that t h a t comprise c o m p r i s e the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M configuration. c o n f i g u r a t i o n . [Class [ C l a s s A, A , B, B , C] C ] 8.2 8 . 2 * * Change C h a n g e control c o n t r o l 8.2.1 8 . 2 . 1 Approve A p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l change c h a n g e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S identified i d e n t i f i e d to t o be b e controlled c o n t r o l l e d according a c c o r d i n g to t o 8.1 8 . 1 only o n l y in i n response r e s p o n s e to t o an a n approved a p p r o v e d CHANGE C H A N G E REQUEST. R E Q U E S T . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E 1 1 The T h e decision d e c i s i o n to t o approve a p p r o v e a a CHANGE C H A N G E REQUEST R E Q U E S T can c a n be b e integral i n t e g r a l to t o the t h e change c h a n g e control c o n t r o l PROCESS P R O C E S S or o r part p a r t of o f another a n o t h e r PROCESS. P R O C E S S . This T h i s subclause s u b c l a u s e only o n l y requires r e q u i r e s that t h a t approval a p p r o v a l of o f a a change c h a n g e precede p r e c e d e its i t s implementation. i m p l e m e n t a t i o n . NOTE N O T E 2 2 Different D i f f e r e n t acceptance a c c e p t a n c e PROCESSES P R O C E S S E S can c a n be b e used u s e d for f o r CHANGE C H A N G E REQUESTS R E Q U E S T S at a t different d i f f e r e n t stages s t a g e s of o f the t h e life l i f e cycle, c y c l e , as a s stated s t a t e d in i n plans, p l a n s , see s e e 5.1.1 5 . 1 . 1 d) d ) and a n d 6.1 6 . 1 e). e ) . 8.2.2 8 . 2 . 2 Implement I m p l e m e n t changes c h a n g e s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l implement i m p l e m e n t the t h e change c h a n g e as a s specified s p e c i f i e d in i n the t h e CHANGE C H A N G E REQUEST. R E Q U E S T . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l identify i d e n t i f y and a n d perform p e r f o r m any a n y ACTIVITY A C T I V I T Y that t h a t needs n e e d s to t o be b e repeated r e p e a t e d as a s a a result r e s u l t of o f the t h e change, c h a n g e , including i n c l u d i n g changes c h a n g e s to t o the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S and a n d SOFTWARE S O F T W A R E ITEMS. I T E M S . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s subclause s u b c l a u s e states s t a t e s how h o w the t h e change c h a n g e should s h o u l d be b e implemented i m p l e m e n t e d to t o achieve a c h i e v e adequate a d e q u a t e change c h a n g e control. c o n t r o l . It I t does d o e s not n o t imply i m p l y that t h a t the t h e implementation i m p l e m e n t a t i o n is i s an a n integral i n t e g r a l part p a r t of o f the t h e change c h a n g e control c o n t r o l PROCESS. P R O C E S S . Implementation I m p l e m e n t a t i o n should s h o u l d use u s e planned p l a n n e d PROCESSES, P R O C E S S E S , see s e e 5.1.1 5 . 1 . 1 e) e ) and a n d 6.1 6 . 1 e). e ) . 8.2.3 8 . 2 . 3 Verify V e r i f y changes c h a n g e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y the t h e change, c h a n g e , including i n c l u d i n g repeating r e p e a t i n g any a n y VERIFICATION V E R I F I C A T I O N that t h a t has h a s been b e e n invalidated i n v a l i d a t e d by b y the t h e change c h a n g e and a n d taking t a k i n g into i n t o account a c c o u n t 5.7.3 5 . 7 . 3 and a n d 9.7. 9 . 7 . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E This T h i s subclause s u b c l a u s e only o n l y requires r e q u i r e s that t h a t changes c h a n g e s be b e VERIFIED. V E R I F I E D . It I t does d o e s not n o t imply i m p l y that t h a t VERIFICATION V E R I F I C A T I O N is i s an a n integral i n t e g r a l part p a r t of o f the t h e change c h a n g e control c o n t r o l PROCESS. P R O C E S S . VERIFICATION V E R I F I C A T I O N should s h o u l d use u s e planned p l a n n e d PROCESSES, P R O C E S S E S , see s e e 5.1.1 5 . 1 . 1 e) e ) and a n d 6.1 6 . 1 e). e ) . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 33 3 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 8.2.4 8 . 2 . 4 Provide P r o v i d e means m e a n s for f o r TRACEABILITY T R A C E A B I L I T Y of o f change c h a n g e The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l maintain m a i n t a i n records r e c o r d s of o f the t h e relationships r e l a t i o n s h i p s and a n d dependencies d e p e n d e n c i e s between: b e t w e e n : a) a ) CHANGE C H A N G E REQUEST; R E Q U E S T ; relevant r e l e v a n t PROBLEM P R O B L E M REPORT; R E P O R T ; and a n d approval a p p r o v a l of o f the t h e CHANGE C H A N G E REQUEST R E Q U E S T [Class [ C l a s s A, A , B, B , C] C ] 8.3 8 . 3 * * Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l retain r e t a i n retrievable r e t r i e v a b l e records r e c o r d s of o f the t h e history h i s t o r y of o f controlled c o n t r o l l e d CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S including i n c l u d i n g SYSTEM S Y S T E M configuration. c o n f i g u r a t i o n . [Class [ C l a s s A, A , B, B , C] C ] 9 9 * * Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l prepare p r e p a r e a a PROBLEM P R O B L E M REPORT R E P O R T for f o r each e a c h problem p r o b l e m detected d e t e c t e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . PROBLEM P R O B L E M REPORTS R E P O R T S shall s h a l l include i n c l u d e a a statement s t a t e m e n t of o f criticality c r i t i c a l i t y (for ( f o r example, e x a m p l e , effect e f f e c t on o n performance, p e r f o r m a n c e , SAFETY, S A F E T Y , or o r SECURITY) S E C U R I T Y ) as a s well w e l l as a s other o t h e r information i n f o r m a t i o n that t h a t may m a y aid a i d in i n the t h e resolution r e s o l u t i o n of o f the t h e problem p r o b l e m (for ( f o r example, e x a m p l e , devices d e v i c e s affected, a f f e c t e d , supported s u p p o r t e d accessories a c c e s s o r i e s affected). a f f e c t e d ) . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Problems P r o b l e m s can c a n be b e discovered d i s c o v e r e d before b e f o r e or o r after a f t e r release, r e l e a s e , inside i n s i d e the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S organization o r g a n i z a t i o n or o r outside o u t s i d e it. i t . 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem p r o b l e m The T h e MANUFACTURER M A N U F A C T U R E R shall: s h a l l : investigate i n v e s t i g a t e the t h e problem p r o b l e m and a n d if i f possible p o s s i b l e identify i d e n t i f y the t h e causes; c a u s e s ; EVALUATE E V A L U A T E the t h e problem’s p r o b l e m ’ s relevance r e l e v a n c e to t o SAFETY S A F E T Y using u s i n g the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S (Clause ( C l a u s e 7); 7 ) ; document d o c u m e n t the t h e outcome o u t c o m e of o f the t h e investigation i n v e s t i g a t i o n and a n d evaluation; e v a l u a t i o n ; and a n d create c r e a t e a a CHANGE C H A N G E REQUEST(S) R E Q U E S T ( S ) for f o r actions a c t i o n s needed n e e d e d to t o correct c o r r e c t the t h e problem, p r o b l e m , or o r document d o c u m e n t the t h e rationale r a t i o n a l e for f o r taking t a k i n g no n o action. a c t i o n . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E A A problem p r o b l e m does d o e s not n o t have h a v e to t o be b e corrected c o r r e c t e d for f o r the t h e MANUFACTURER M A N U F A C T U R E R to t o comply c o m p l y with w i t h the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS, P R O C E S S , provided p r o v i d e d that t h a t the t h e problem p r o b l e m is i s not n o t relevant r e l e v a n t to t o SAFETY. S A F E T Y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties p a r t i e s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l advise a d v i s e relevant r e l e v a n t parties p a r t i e s of o f the t h e existence e x i s t e n c e of o f the t h e problem, p r o b l e m , as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] NOTE N O T E Problems P r o b l e m s can c a n be b e discovered d i s c o v e r e d before b e f o r e or o r after a f t e r release, r e l e a s e , inside i n s i d e the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S organisation o r g a n i s a t i o n or o r outside o u t s i d e it. i t . The T h e MANUFACTURER M A N U F A C T U R E R determines d e t e r m i n e s the t h e relevant r e l e v a n t parties p a r t i e s depending d e p e n d i n g on o n the t h e situation. s i t u a t i o n . 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process p r o c e s s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l approve a p p r o v e and a n d implement i m p l e m e n t all a l l CHANGE C H A N G E REQUESTS, R E Q U E S T S , observing o b s e r v i n g the t h e requirements r e q u i r e m e n t s of o f the t h e change c h a n g e control c o n t r o l PROCESS P R O C E S S (see ( s e e 8.2). 8 . 2 ) . [Class [ C l a s s A, A , B, B , C] C ] granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} 9.5 9 . 5 Maintain M a i n t a i n records r e c o r d s – – 34 3 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l maintain m a i n t a i n records r e c o r d s of o f PROBLEM P R O B L E M REPORTS R E P O R T S and a n d their t h e i r resolution r e s o l u t i o n including i n c l u d i n g their t h e i r VERIFICATION. V E R I F I C A T I O N . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l update u p d a t e the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E as a s appropriate. a p p r o p r i a t e . [Class [ C l a s s A, A , B, B , C] C ] 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends t r e n d s The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l perform p e r f o r m analysis a n a l y s i s to t o detect d e t e c t trends t r e n d s in i n PROBLEM P R O B L E M REPORTS. R E P O R T S . [Class [ C l a s s A, A , B, B , C] C ] 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l verify v e r i f y resolutions r e s o l u t i o n s to t o determine d e t e r m i n e whether: w h e t h e r : problem p r o b l e m has h a s been b e e n resolved r e s o l v e d and a n d the t h e PROBLEM P R O B L E M REPORT R E P O R T has h a s been b e e n closed; c l o s e d ; adverse a d v e r s e trends t r e n d s have h a v e been b e e n reversed; r e v e r s e d ; CHANGE C H A N G E REQUESTS R E Q U E S T S have h a v e been b e e n implemented i m p l e m e n t e d in i n the t h e appropriate a p p r o p r i a t e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d ACTIVITIES; A C T I V I T I E S ; and a n d additional a d d i t i o n a l problems p r o b l e m s have h a v e been b e e n introduced. i n t r o d u c e d . [Class [ C l a s s A, A , B, B , C] C ] 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents c o n t e n t s When W h e n testing, t e s t i n g , retesting r e t e s t i n g or o r REGRESSION R E G R E S S I O N TESTING T E S T I N G SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SYSTEMS S Y S T E M S following f o l l o w i n g a a change, c h a n g e , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l include i n c l u d e in i n the t h e test t e s t documentation: d o c u m e n t a t i o n : test t e s t results; r e s u l t s ; ANOMALIES A N O M A L I E S found; f o u n d ; the t h e VERSION V E R S I O N of o f software s o f t w a r e tested; t e s t e d ; relevant r e l e v a n t hardware h a r d w a r e and a n d software s o f t w a r e test t e s t configurations; c o n f i g u r a t i o n s ; relevant r e l e v a n t test t e s t tools; t o o l s ; date d a t e tested; t e s t e d ; and a n d identification i d e n t i f i c a t i o n of o f the t h e tester. t e s t e r . [Class [ C l a s s A, A , B, B , C] C ] Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 35 3 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x A A (informative) ( i n f o r m a t i v e ) Rationale R a t i o n a l e for f o r the t h e requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d Rationale R a t i o n a l e for f o r the t h e clauses c l a u s e s of o f this t h i s standard s t a n d a r d is i s provided p r o v i d e d in i n this t h i s annex. a n n e x . A.1 A . 1 Rationale R a t i o n a l e The T h e primary p r i m a r y requirement r e q u i r e m e n t of o f this t h i s standard s t a n d a r d is i s that t h a t a a set s e t of o f PROCESSES P R O C E S S E S be b e followed f o l l o w e d in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , and a n d that t h a t the t h e choice c h o i c e of o f PROCESSES P R O C E S S E S be b e appropriate a p p r o p r i a t e to t o the t h e RISKS R I S K S to t o the t h e patient p a t i e n t and a n d other o t h e r people. p e o p l e . This T h i s follows f o l l o w s from f r o m the t h e belief b e l i e f that t h a t testing t e s t i n g of o f software s o f t w a r e is i s not n o t sufficient s u f f i c i e n t to t o determine d e t e r m i n e that t h a t it i t is i s safe s a f e in i n operation. o p e r a t i o n . The T h e PROCESSES P R O C E S S E S required r e q u i r e d by b y this t h i s standard s t a n d a r d fall f a l l into i n t o two t w o categories: c a t e g o r i e s : – – PROCESSES P R O C E S S E S which w h i c h are a r e required r e q u i r e d to t o determine d e t e r m i n e the t h e RISKS R I S K S arising a r i s i n g from f r o m the t h e operation o p e r a t i o n of o f each e a c h SOFTWARE S O F T W A R E ITEM I T E M in i n the t h e software; s o f t w a r e ; – – PROCESSES P R O C E S S E S which w h i c h are a r e required r e q u i r e d to t o achieve a c h i e v e an a n appropriately a p p r o p r i a t e l y low l o w probability p r o b a b i l i t y of o f software s o f t w a r e failure f a i l u r e for f o r each e a c h SOFTWARE S O F T W A R E ITEM, I T E M , chosen c h o s e n on o n the t h e basis b a s i s of o f these t h e s e determined d e t e r m i n e d RISKS. R I S K S . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e first f i r s t category c a t e g o r y to t o be b e performed p e r f o r m e d for f o r all a l l MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E and a n d the t h e second s e c o n d category c a t e g o r y to t o be b e performed p e r f o r m e d for f o r selected s e l e c t e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A claim c l a i m of o f compliance c o m p l i a n c e with w i t h this t h i s standard s t a n d a r d should s h o u l d therefore t h e r e f o r e include i n c l u d e a a documented d o c u m e n t e d RISK R I S K ANALYSIS A N A L Y S I S that t h a t identifies i d e n t i f i e s foreseeable f o r e s e e a b l e sequences s e q u e n c e s of o f events e v e n t s that t h a t include i n c l u d e software s o f t w a r e and a n d that t h a t can c a n result r e s u l t in i n a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N (see ( s e e ISO I S O 14971). 1 4 9 7 1 ) . HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t can c a n be b e indirectly i n d i r e c t l y caused c a u s e d by b y software s o f t w a r e (for ( f o r example, e x a m p l e , by b y providing p r o v i d i n g misleading m i s l e a d i n g information i n f o r m a t i o n that t h a t could c o u l d cause c a u s e inappropriate i n a p p r o p r i a t e treatment t r e a t m e n t to t o be b e administered) a d m i n i s t e r e d ) should s h o u l d be b e included i n c l u d e d in i n this t h i s RISK R I S K ANALYSIS. A N A L Y S I S . All A l l ACTIVITIES A C T I V I T I E S that t h a t are a r e required r e q u i r e d as a s part p a r t of o f the t h e first f i r s t category c a t e g o r y of o f PROCESSES P R O C E S S E S are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t as a s "[Class " [ C l a s s A, A , B, B , C]", C ] " , indicating i n d i c a t i n g that t h a t they t h e y are a r e required r e q u i r e d irrespective i r r e s p e c t i v e of o f the t h e classification c l a s s i f i c a t i o n of o f the t h e software s o f t w a r e to t o which w h i c h they t h e y apply. a p p l y . ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d for f o r all a l l classes c l a s s e s A, A , B, B , and a n d C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s a a plan p l a n relevant r e l e v a n t to t o RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s an a n output o u t p u t that t h a t is i s an a n input i n p u t to t o RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y is i s a a part p a r t of o f RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y establishes e s t a b l i s h e s an a n administration a d m i n i s t r a t i o n system, s y s t e m , documentation d o c u m e n t a t i o n or o r record-keeping r e c o r d - k e e p i n g system s y s t e m that t h a t supports s u p p o r t s RISK R I S K MANAGEMENT M A N A G E M E N T or o r software s o f t w a r e safety s a f e t y classification; c l a s s i f i c a t i o n ; – – the t h e ACTIVITY A C T I V I T Y normally n o r m a l l y takes t a k e s place p l a c e when w h e n the t h e classification c l a s s i f i c a t i o n of o f the t h e related r e l a t e d software s o f t w a r e is i s unknown; u n k n o w n ; – – the t h e ACTIVITY A C T I V I T Y can c a n cause c a u s e a a change c h a n g e that t h a t could c o u l d invalidate i n v a l i d a t e the t h e current c u r r e n t software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e associated a s s o c i a t e d software. s o f t w a r e . This T h i s includes i n c l u d e s the t h e discovery d i s c o v e r y and a n d analysis a n a l y s i s of o f safety s a f e t y related r e l a t e d problems p r o b l e m s after a f t e r release. r e l e a s e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Other O t h e r PROCESSES P R O C E S S E S are a r e required r e q u i r e d only o n l y for f o r SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S or o r SOFTWARE S O F T W A R E ITEMS I T E M S classified c l a s s i f i e d in i n software s o f t w a r e safety s a f e t y classes c l a s s e s B B or o r C. C . ACTIVITIES A C T I V I T I E S required r e q u i r e d as a s parts p a r t s of o f these t h e s e PROCESSES P R O C E S S E S are a r e identified i d e n t i f i e d in i n the t h e normative n o r m a t i v e text t e x t as a s "[Class " [ C l a s s B, B , C]", C ] " , or o r "[Class " [ C l a s s C]" C ] " indicating i n d i c a t i n g that t h a t they t h e y are a r e required r e q u i r e d selectively s e l e c t i v e l y depending d e p e n d i n g on o n the t h e classification c l a s s i f i c a t i o n of o f the t h e software s o f t w a r e to t o which w h i c h they t h e y apply. a p p l y . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 36 3 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d selectively s e l e c t i v e l y for f o r software s o f t w a r e in i n classes c l a s s e s B B and a n d C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y enhances e n h a n c e s the t h e reliability r e l i a b i l i t y of o f the t h e software s o f t w a r e by b y requiring r e q u i r i n g more m o r e detail d e t a i l or o r more m o r e rigor r i g o r in i n the t h e design, d e s i g n , testing t e s t i n g or o r other o t h e r VERIFICATION; V E R I F I C A T I O N ; – – the t h e ACTIVITY A C T I V I T Y is i s an a n administrative a d m i n i s t r a t i v e ACTIVITY A C T I V I T Y that t h a t supports s u p p o r t s another a n o t h e r ACTIVITY A C T I V I T Y required r e q u i r e d for f o r classes c l a s s e s B B or o r C; C ; – – the t h e ACTIVITY A C T I V I T Y supports s u p p o r t s the t h e correction c o r r e c t i o n of o f safety-related s a f e t y - r e l a t e d problems; p r o b l e m s ; – – the t h e ACTIVITY A C T I V I T Y produces p r o d u c e s records r e c o r d s of o f design, d e s i g n , implementation, i m p l e m e n t a t i o n , VERIFICATION V E R I F I C A T I O N and a n d release r e l e a s e of o f safety- s a f e t y - related r e l a t e d software. s o f t w a r e . ACTIVITIES A C T I V I T I E S are a r e required r e q u i r e d selectively s e l e c t i v e l y for f o r software s o f t w a r e in i n class c l a s s C C for f o r the t h e following f o l l o w i n g reasons: r e a s o n s : – – the t h e ACTIVITY A C T I V I T Y further f u r t h e r enhances e n h a n c e s the t h e reliability r e l i a b i l i t y of o f the t h e software s o f t w a r e by b y requiring r e q u i r i n g more m o r e detail, d e t a i l , or o r more m o r e rigour, r i g o u r , or o r attention a t t e n t i o n to t o specific s p e c i f i c issues i s s u e s in i n the t h e design, d e s i g n , testing t e s t i n g or o r other o t h e r VERIFICATION V E R I F I C A T I O N Note N o t e that t h a t all a l l PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n this t h i s standard s t a n d a r d are a r e considered c o n s i d e r e d valuable v a l u a b l e in i n assuring a s s u r i n g the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f high h i g h quality q u a l i t y software. s o f t w a r e . The T h e omission o m i s s i o n of o f many m a n y of o f these t h e s e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S as a s requirements r e q u i r e m e n t s for f o r software s o f t w a r e in i n class c l a s s A A should s h o u l d not n o t imply i m p l y that t h a t these t h e s e PROCESSES P R O C E S S E S and a n d ACTIVITIES A C T I V I T I E S would w o u l d not n o t be b e of o f value v a l u e or o r are a r e not n o t recommended. r e c o m m e n d e d . Their T h e i r omission o m i s s i o n is i s intended i n t e n d e d to t o recognize r e c o g n i z e that t h a t software s o f t w a r e that t h a t cannot c a n n o t cause c a u s e a a HAZARD H A Z A R D can c a n be b e assured a s s u r e d of o f SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s primarily p r i m a r i l y through t h r o u g h overall o v e r a l l validation v a l i d a t i o n ACTIVITY A C T I V I T Y during d u r i n g the t h e design d e s i g n of o f a a MEDICAL M E D I C A L DEVICE D E V I C E (which ( w h i c h is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard) s t a n d a r d ) and a n d through t h r o u g h some s o m e simple s i m p l e software s o f t w a r e life l i f e cycle c y c l e controls. c o n t r o l s . A.2 A . 2 Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y class c l a s s Table T a b l e A.1 A . 1 summarizes s u m m a r i z e s which w h i c h software s o f t w a r e safety s a f e t y classes c l a s s e s are a r e assigned a s s i g n e d to t o each e a c h requirement. r e q u i r e m e n t . This T h i s table t a b l e is i s informative i n f o r m a t i v e and a n d only o n l y provided p r o v i d e d for f o r convenience. c o n v e n i e n c e . The T h e normative n o r m a t i v e section s e c t i o n identifies i d e n t i f i e s the t h e software s o f t w a r e safety s a f e t y classes c l a s s e s for f o r each e a c h requirement. r e q u i r e m e n t . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 37 3 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e A.1 A . 1 – – Summary S u m m a r y of o f requirements r e q u i r e m e n t s by b y software s o f t w a r e safety s a f e t y class c l a s s Clauses C l a u s e s and a n d subclauses s u b c l a u s e s Class C l a s s A A Class C l a s s B B Class C l a s s C C Clause C l a u s e 4 4 All A l l requirements r e q u i r e m e n t s X X X X X X 5.1 5 . 1 5.1.1, 5 . 1 . 1 , 5.1.2, 5 . 1 . 2 , 5.1.3, 5 . 1 . 3 , 5.1.6, 5 . 1 . 6 , 5.1.7, 5 . 1 . 7 , 5.1.8, 5 . 1 . 8 , 5.1.9 5 . 1 . 9 X X X X X X 5.1.5, 5 . 1 . 5 , 5.1.10, 5 . 1 . 1 0 , 5.1.11, 5 . 1 . 1 1 , 5.1.12 5 . 1 . 1 2 X X X X 5.1.4 5 . 1 . 4 X X 5.2 5 . 2 5.2.1, 5 . 2 . 1 , 5.2.2, 5 . 2 . 2 , 5.2.4, 5 . 2 . 4 , 5.2.5, 5 . 2 . 5 , 5.2.6 5 . 2 . 6 X X X X X X 5.2.3 5 . 2 . 3 X X X X 5.3 5 . 3 5.3.1, 5 . 3 . 1 , 5.3.2, 5 . 3 . 2 , 5.3.3, 5 . 3 . 3 , 5.3.4, 5 . 3 . 4 , 5.3.6 5 . 3 . 6 X X X X 5.3.5 5 . 3 . 5 X X 5.4 5 . 4 5.4.1 5 . 4 . 1 X X X X 5.4.2, 5 . 4 . 2 , 5.4.3, 5 . 4 . 3 , 5.4.4 5 . 4 . 4 X X 5.5 5 . 5 5.5.1 5 . 5 . 1 X X X X X X 5.5.2, 5 . 5 . 2 , 5.5.3, 5 . 5 . 3 , 5.5.5 5 . 5 . 5 X X X X 5.5.4 5 . 5 . 4 X X 5.6 5 . 6 All A l l requirements r e q u i r e m e n t s X X X X 5.7 5 . 7 All A l l requirements r e q u i r e m e n t s X X X X X X 5.8 5 . 8 5.8.1, 5 . 8 . 1 , 5.8.2, 5 . 8 . 2 , 5.8.4, 5 . 8 . 4 , 5.8.7, 5 . 8 . 7 , 5.8.8 5 . 8 . 8 X X X X X X 5.8.3, 5 . 8 . 3 , 5.8.5, 5 . 8 . 5 , 5.8.6 5 . 8 . 6 X X X X Clause C l a u s e 6 6 All A l l requirements r e q u i r e m e n t s X X X X X X 7.1 7 . 1 All A l l requirements r e q u i r e m e n t s X X X X 7.2 7 . 2 All A l l requirements r e q u i r e m e n t s X X X X 7.3 7 . 3 All A l l requirements r e q u i r e m e n t s X X X X 7.4 7 . 4 7.4.1 7 . 4 . 1 X X X X X X 7.4.2, 7 . 4 . 2 , 7.4.3 7 . 4 . 3 X X X X Clause C l a u s e 8 8 All A l l requirements r e q u i r e m e n t s X X X X X X Clause C l a u s e 9 9 All A l l requirements r e q u i r e m e n t s X X X X X X Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 38 3 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x B B (informative) ( i n f o r m a t i v e ) Guidance G u i d a n c e on o n the t h e provisions p r o v i s i o n s of o f this t h i s standard s t a n d a r d B.1 B . 1 Scope S c o p e B.1.1 B . 1 . 1 Purpose P u r p o s e The T h e purpose p u r p o s e of o f this t h i s standard s t a n d a r d is i s to t o provide p r o v i d e a a development d e v e l o p m e n t PROCESS P R O C E S S that t h a t will w i l l consistently c o n s i s t e n t l y produce p r o d u c e high h i g h quality, q u a l i t y , safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . To T o accomplish a c c o m p l i s h this, t h i s , the t h e standard s t a n d a r d identifies i d e n t i f i e s the t h e minimum m i n i m u m ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S that t h a t need n e e d to t o be b e accomplished a c c o m p l i s h e d to t o provide p r o v i d e confidence c o n f i d e n c e that t h a t the t h e software s o f t w a r e has h a s been b e e n developed d e v e l o p e d in i n a a manner m a n n e r that t h a t is i s likely l i k e l y to t o produce p r o d u c e highly h i g h l y reliable r e l i a b l e and a n d safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s annex a n n e x provides p r o v i d e s guidance g u i d a n c e for f o r the t h e application a p p l i c a t i o n of o f the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . It I t does d o e s not n o t add a d d to, t o , or o r otherwise o t h e r w i s e change, c h a n g e , the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . This T h i s annex a n n e x can c a n be b e used u s e d to t o better b e t t e r understand u n d e r s t a n d the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . Note N o t e that t h a t in i n this t h i s standard, s t a n d a r d , ACTIVITIES A C T I V I T I E S are a r e subclauses s u b c l a u s e s called c a l l e d out o u t within w i t h i n the t h e PROCESSES P R O C E S S E S and a n d TASKS T A S K S are a r e defined d e f i n e d within w i t h i n the t h e ACTIVITIES. A C T I V I T I E S . For F o r example, e x a m p l e , the t h e ACTIVITIES A C T I V I T I E S defined d e f i n e d for f o r the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S are a r e software s o f t w a r e development d e v e l o p m e n t planning, p l a n n i n g , software s o f t w a r e requirements r e q u i r e m e n t s analysis, a n a l y s i s , software s o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design, d e s i g n , software s o f t w a r e detailed d e t a i l e d design, d e s i g n , SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d VERIFICATION, V E R I F I C A T I O N , software s o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing, t e s t i n g , SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing, t e s t i n g , and a n d software s o f t w a r e release. r e l e a s e . The T h e TASKS T A S K S within w i t h i n these t h e s e ACTIVITIES A C T I V I T I E S are a r e the t h e individual i n d i v i d u a l requirements. r e q u i r e m e n t s . This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e a a particular p a r t i c u l a r SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL. M O D E L . However, H o w e v e r , compliance c o m p l i a n c e with w i t h this t h i s standard s t a n d a r d does d o e s imply i m p l y dependencies d e p e n d e n c i e s between b e t w e e n PROCESSES, P R O C E S S E S , because b e c a u s e inputs i n p u t s of o f a a PROCESS P R O C E S S are a r e generated g e n e r a t e d by b y another a n o t h e r PROCESS. P R O C E S S . For F o r example, e x a m p l e , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M should s h o u l d be b e completed c o m p l e t e d after a f t e r the t h e RISK R I S K ANALYSIS A N A L Y S I S PROCESS P R O C E S S has h a s established e s t a b l i s h e d what w h a t HARM H A R M could c o u l d arise a r i s e from f r o m failure f a i l u r e of o f the t h e SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . Because B e c a u s e of o f such s u c h logical l o g i c a l dependencies d e p e n d e n c i e s between b e t w e e n processes, p r o c e s s e s , it i t is i s easiest e a s i e s t to t o describe d e s c r i b e the t h e processes p r o c e s s e s in i n this t h i s standard s t a n d a r d in i n a a sequence, s e q u e n c e , implying i m p l y i n g a a “waterfall” “ w a t e r f a l l ” or o r “once-through” “ o n c e - t h r o u g h ” life l i f e cycle c y c l e model. m o d e l . However, H o w e v e r , other o t h e r life l i f e cycles c y c l e s can c a n also a l s o be b e used. u s e d . Some S o m e development d e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d at a t ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] include i n c l u d e (see ( s e e also a l s o Table T a b l e B.1): B . 1 ) : – – Waterfall. W a t e r f a l l . The T h e “once-through" “ o n c e - t h r o u g h " strategy, s t r a t e g y , also a l s o called c a l l e d “waterfall”, “ w a t e r f a l l ” , consists c o n s i s t s of o f performing p e r f o r m i n g the t h e development d e v e l o p m e n t PROCESS P R O C E S S a a single s i n g l e time. t i m e . Simplistically: S i m p l i s t i c a l l y : determine d e t e r m i n e customer c u s t o m e r needs, n e e d s , define d e f i n e requirements, r e q u i r e m e n t s , design d e s i g n the t h e SYSTEM, S Y S T E M , implement i m p l e m e n t the t h e system, s y s t e m , test, t e s t , fix f i x and a n d deliver. d e l i v e r . – – Incremental: I n c r e m e n t a l : The T h e “incremental” “ i n c r e m e n t a l ” strategy s t r a t e g y determines d e t e r m i n e s customer c u s t o m e r needs n e e d s and a n d defines d e f i n e s the t h e SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , then t h e n performs p e r f o r m s the t h e rest r e s t of o f the t h e development d e v e l o p m e n t in i n a a sequence s e q u e n c e of o f builds. b u i l d s . The T h e first f i r s t build b u i l d incorporates i n c o r p o r a t e s part p a r t of o f the t h e planned p l a n n e d capabilities, c a p a b i l i t i e s , the t h e next n e x t build b u i l d adds a d d s more m o r e capabilities, c a p a b i l i t i e s , and a n d so s o on, o n , until u n t i l the t h e SYSTEM S Y S T E M is i s complete. c o m p l e t e . – – Evolutionary: E v o l u t i o n a r y : The T h e “evolutionary” “ e v o l u t i o n a r y ” strategy s t r a t e g y also a l s o develops d e v e l o p s a a SYSTEM S Y S T E M in i n builds b u i l d s but b u t differs d i f f e r s from f r o m the t h e incremental i n c r e m e n t a l strategy s t r a t e g y in i n acknowledging a c k n o w l e d g i n g that t h a t the t h e user u s e r need n e e d is i s not n o t fully f u l l y understood u n d e r s t o o d and a n d all a l l requirements r e q u i r e m e n t s cannot c a n n o t be b e defined d e f i n e d up u p front. f r o n t . In I n this t h i s strategy, s t r a t e g y , customer c u s t o m e r needs n e e d s and a n d SYSTEM S Y S T E M requirements r e q u i r e m e n t s are a r e partially p a r t i a l l y defined d e f i n e d up u p front, f r o n t , then t h e n are a r e refined r e f i n e d in i n each e a c h succeeding s u c c e e d i n g build. b u i l d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 39 3 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e B.1 B . 1 – – Development D e v e l o p m e n t (model) ( m o d e l ) strategies s t r a t e g i e s as a s defined d e f i n e d in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 Development D e v e l o p m e n t Strategy S t r a t e g y Define D e f i n e all a l l requirements r e q u i r e m e n t s first? f i r s t ? Multiple M u l t i p l e development d e v e l o p m e n t cycles? c y c l e s ? Distribute D i s t r i b u t e interim i n t e r i m software? s o f t w a r e ? Waterfall W a t e r f a l l (Once-through) ( O n c e - t h r o u g h ) Incremental I n c r e m e n t a l (Preplanned ( P r e p l a n n e d product p r o d u c t improvement) i m p r o v e m e n t ) yes y e s no n o no n o yes y e s yes y e s maybe m a y b e Evolutionary E v o l u t i o n a r y no n o yes y e s yes y e s Whichever W h i c h e v e r life l i f e cycle c y c l e is i s chosen c h o s e n it i t is i s necessary n e c e s s a r y to t o maintain m a i n t a i n the t h e logical l o g i c a l dependencies d e p e n d e n c i e s between b e t w e e n PROCESS P R O C E S S outputs o u t p u t s such s u c h as a s specifications, s p e c i f i c a t i o n s , design d e s i g n documents d o c u m e n t s and a n d software. s o f t w a r e . The T h e waterfall w a t e r f a l l life l i f e cycle c y c l e model m o d e l achieves a c h i e v e s this t h i s by b y delaying d e l a y i n g the t h e start s t a r t of o f a a PROCESS P R O C E S S until u n t i l the t h e inputs i n p u t s for f o r that t h a t PROCESS P R O C E S S are a r e complete c o m p l e t e and a n d approved. a p p r o v e d . Other O t h e r life l i f e cycles, c y c l e s , particularly p a r t i c u l a r l y evolutionary e v o l u t i o n a r y life l i f e cycles, c y c l e s , permit p e r m i t PROCESS P R O C E S S outputs o u t p u t s to t o be b e produced p r o d u c e d before b e f o r e all a l l the t h e inputs i n p u t s for f o r that t h a t PROCESS P R O C E S S are a r e available. a v a i l a b l e . For F o r example, e x a m p l e , a a new n e w SOFTWARE S O F T W A R E ITEM I T E M can c a n be b e specified, s p e c i f i e d , classified, c l a s s i f i e d , implemented i m p l e m e n t e d and a n d VERIFIED V E R I F I E D before b e f o r e the t h e whole w h o l e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E has h a s been b e e n finalised. f i n a l i s e d . Such S u c h life l i f e cycles c y c l e s carry c a r r y the t h e RISK R I S K that t h a t a a change c h a n g e or o r development d e v e l o p m e n t in i n one o n e PROCESS P R O C E S S output o u t p u t will w i l l invalidate i n v a l i d a t e another a n o t h e r PROCESS P R O C E S S output. o u t p u t . All A l l life l i f e cycles c y c l e s therefore t h e r e f o r e use u s e a a comprehensive c o m p r e h e n s i v e configuration c o n f i g u r a t i o n management m a n a g e m e n t system s y s t e m to t o ensure e n s u r e that t h a t all a l l PROCESS P R O C E S S outputs o u t p u t s are a r e brought b r o u g h t to t o a a consistent c o n s i s t e n t state s t a t e and a n d the t h e dependencies d e p e n d e n c i e s maintained. m a i n t a i n e d . The T h e following f o l l o w i n g principles p r i n c i p l e s are a r e important i m p o r t a n t regardless r e g a r d l e s s of o f the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle c y c l e used: u s e d : – – All A l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e maintained m a i n t a i n e d in i n a a consistent c o n s i s t e n t state; s t a t e ; whenever w h e n e v e r any a n y PROCESS P R O C E S S output o u t p u t is i s created c r e a t e d or o r changed, c h a n g e d , all a l l related r e l a t e d PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e updated u p d a t e d promptly p r o m p t l y to t o maintain m a i n t a i n their t h e i r consistency c o n s i s t e n c y with w i t h each e a c h other o t h e r and a n d to t o maintain m a i n t a i n all a l l dependencies d e p e n d e n c i e s explicitly e x p l i c i t l y or o r implicitly i m p l i c i t l y required r e q u i r e d by b y this t h i s standard; s t a n d a r d ; – – all a l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e available a v a i l a b l e when w h e n needed n e e d e d as a s input i n p u t to t o further f u r t h e r work w o r k on o n the t h e software. s o f t w a r e . – – before b e f o r e any a n y MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s released, r e l e a s e d , all a l l PROCESS P R O C E S S outputs o u t p u t s should s h o u l d be b e consistent c o n s i s t e n t with w i t h each e a c h other o t h e r and a n d all a l l dependencies d e p e n d e n c i e s between b e t w e e n PROCESS P R O C E S S outputs o u t p u t s explicitly e x p l i c i t l y or o r implicitly i m p l i c i t l y required r e q u i r e d by b y this t h i s standard s t a n d a r d should s h o u l d be b e observed. o b s e r v e d . B.1.2 B . 1 . 2 Field F i e l d of o f application a p p l i c a t i o n This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E as a s well w e l l as a s the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f a a MEDICAL M E D I C A L DEVICE D E V I C E that t h a t includes i n c l u d e s SOUP. S O U P . The T h e use u s e of o f this t h i s standard s t a n d a r d requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o perform p e r f o r m MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971. 1 4 9 7 1 . Therefore, T h e r e f o r e , when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E includes i n c l u d e s an a n acquired a c q u i r e d component c o m p o n e n t (this ( t h i s could c o u l d be b e a a purchased p u r c h a s e d component c o m p o n e n t or o r a a component c o m p o n e n t of o f unknown u n k n o w n provenance), p r o v e n a n c e ) , such s u c h as a s a a printer/plotter p r i n t e r / p l o t t e r that t h a t includes i n c l u d e s SOUP, S O U P , the t h e acquired a c q u i r e d component c o m p o n e n t becomes b e c o m e s the t h e responsibility r e s p o n s i b i l i t y of o f the t h e MANUFACTURER M A N U F A C T U R E R and a n d must m u s t be b e included i n c l u d e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T of o f the t h e MEDICAL M E D I C A L DEVICE. D E V I C E . It I t is i s assumed a s s u m e d that t h a t through t h r o u g h proper p r o p e r performance p e r f o r m a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT, M A N A G E M E N T , the t h e MANUFACTURER M A N U F A C T U R E R would w o u l d understand u n d e r s t a n d the t h e component c o m p o n e n t and a n d recognize r e c o g n i z e that t h a t it i t includes i n c l u d e s SOUP. S O U P . The T h e MANUFACTURER M A N U F A C T U R E R using u s i n g this t h i s standard s t a n d a r d would w o u l d invoke i n v o k e the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S as a s part p a r t of o f the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e maintenance m a i n t e n a n c e of o f released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E applies a p p l i e s to t o the t h e post-production p o s t - p r o d u c t i o n experience e x p e r i e n c e with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Software S o f t w a r e maintenance m a i n t e n a n c e includes i n c l u d e s the t h e combination c o m b i n a t i o n of o f all a l l technical t e c h n i c a l and a n d administrative a d m i n i s t r a t i v e means, m e a n s , including i n c l u d i n g supervision s u p e r v i s i o n actions, a c t i o n s , to t o act a c t on o n problem p r o b l e m reports r e p o r t s to t o retain r e t a i n an a n item i t e m in, i n , or o r restore r e s t o r e it i t to, t o , a a state s t a t e in i n which w h i c h it i t can c a n perform p e r f o r m a a required r e q u i r e d function f u n c t i o n as a s well w e l l as a s modification m o d i f i c a t i o n requests r e q u e s t s related r e l a t e d to t o released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . For F o r example, e x a m p l e , this t h i s includes i n c l u d e s problem p r o b l e m rectification, r e c t i f i c a t i o n , regulatory r e g u l a t o r y reporting, r e p o r t i n g , re-validation r e - v a l i d a t i o n and a n d preventive p r e v e n t i v e action. a c t i o n . See S e e ISO/IEC I S O / I E C 14764 1 4 7 6 4 [10]. [ 1 0 ] . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} B.2 B . 2 Normative N o r m a t i v e references r e f e r e n c e s – – 40 4 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15] [ 1 5 ] provides p r o v i d e s guidance g u i d a n c e for f o r applying a p p l y i n g a a quality q u a l i t y management m a n a g e m e n t system s y s t e m to t o software s o f t w a r e development. d e v e l o p m e n t . This T h i s guidance g u i d a n c e is i s not n o t required r e q u i r e d by b y this t h i s standard s t a n d a r d but b u t is i s highly h i g h l y recommended. r e c o m m e n d e d . B.3 B . 3 Terms T e r m s and a n d definitions d e f i n i t i o n s Where W h e r e possible, p o s s i b l e , terms t e r m s have h a v e been b e e n defined d e f i n e d using u s i n g definitions d e f i n i t i o n s from f r o m international i n t e r n a t i o n a l standards. s t a n d a r d s . This T h i s standard s t a n d a r d chose c h o s e to t o use u s e three t h r e e terms t e r m s to t o describe d e s c r i b e the t h e decomposition d e c o m p o s i t i o n of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (top ( t o p level). l e v e l ) . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M can c a n be b e a a subsystem s u b s y s t e m of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E (see ( s e e IEC I E C 60601- 6 0 6 0 1 - 1- 1 - 4 4 [2]) [ 2 ] ) or o r a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right, r i g h t , which w h i c h then t h e n becomes b e c o m e s a a software s o f t w a r e MEDICAL M E D I C A L DEVICE. D E V I C E . The T h e lowest l o w e s t level l e v e l that t h a t is i s not n o t further f u r t h e r decomposed d e c o m p o s e d for f o r the t h e purposes p u r p o s e s of o f testing t e s t i n g or o r software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t is i s the t h e SOFTWARE S O F T W A R E UNIT. U N I T . All A l l levels l e v e l s of o f composition, c o m p o s i t i o n , including i n c l u d i n g the t h e top t o p and a n d bottom b o t t o m levels, l e v e l s , can c a n be b e called c a l l e d SOFTWARE S O F T W A R E ITEMS. I T E M S . A A SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , then, t h e n , is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E ITEMS, I T E M S , and a n d each e a c h SOFTWARE S O F T W A R E ITEM I T E M is i s composed c o m p o s e d of o f one o n e or o r more m o r e SOFTWARE S O F T W A R E UNITS U N I T S or o r decomposable d e c o m p o s a b l e SOFTWARE S O F T W A R E ITEMS. I T E M S . The T h e responsibility r e s p o n s i b i l i t y is i s left l e f t to t o the t h e MANUFACTURER M A N U F A C T U R E R to t o provide p r o v i d e the t h e definition d e f i n i t i o n and a n d granularity g r a n u l a r i t y of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d SOFTWARE S O F T W A R E UNITS. U N I T S . Leaving L e a v i n g these t h e s e terms t e r m s vague v a g u e allows a l l o w s one o n e to t o apply a p p l y them t h e m to t o the t h e many m a n y different d i f f e r e n t development d e v e l o p m e n t methods m e t h o d s and a n d types t y p e s of o f software s o f t w a r e used u s e d in i n MEDICAL M E D I C A L DEVICES. D E V I C E S . B.4 B . 4 General G e n e r a l requirements r e q u i r e m e n t s There T h e r e is i s no n o known k n o w n method m e t h o d to t o guarantee g u a r a n t e e 100 1 0 0 % % SAFETY S A F E T Y for f o r any a n y kind k i n d of o f software. s o f t w a r e . There T h e r e are a r e three t h r e e major m a j o r principles p r i n c i p l e s which w h i c h promote p r o m o t e SAFETY S A F E T Y for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE: S O F T W A R E : – – RISK R I S K MANAGEMENT; M A N A G E M E N T ; – – quality q u a l i t y management; m a n a g e m e n t ; – – software s o f t w a r e engineering. e n g i n e e r i n g . For F o r the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E it i t is i s necessary n e c e s s a r y to t o establish e s t a b l i s h RISK R I S K MANAGEMENT M A N A G E M E N T as a s an a n integral i n t e g r a l part p a r t of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m as a s an a n overall o v e r a l l framework f r a m e w o r k for f o r the t h e application a p p l i c a t i o n of o f appropriate a p p r o p r i a t e software s o f t w a r e engineering e n g i n e e r i n g methods m e t h o d s and a n d techniques. t e c h n i q u e s . The T h e combination c o m b i n a t i o n of o f these t h e s e three t h r e e concepts c o n c e p t s allows a l l o w s a a MEDICAL M E D I C A L DEVICE D E V I C E MANUFACTURER M A N U F A C T U R E R to t o follow f o l l o w a a clearly c l e a r l y structured s t r u c t u r e d and a n d consistently c o n s i s t e n t l y repeatable r e p e a t a b l e decision-making d e c i s i o n - m a k i n g PROCESS P R O C E S S to t o promote p r o m o t e SAFETY S A F E T Y for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . B.4.1 B . 4 . 1 Quality Q u a l i t y management m a n a g e m e n t system s y s t e m A A disciplined d i s c i p l i n e d and a n d effective e f f e c t i v e set s e t of o f software s o f t w a r e PROCESSES P R O C E S S E S includes i n c l u d e s organizational o r g a n i z a t i o n a l PROCESSES P R O C E S S E S such s u c h as a s management, m a n a g e m e n t , infrastructure, i n f r a s t r u c t u r e , improvement, i m p r o v e m e n t , and a n d training. t r a i n i n g . To T o avoid a v o i d duplication d u p l i c a t i o n and a n d to t o focus f o c u s this t h i s standard s t a n d a r d on o n software s o f t w a r e engineering, e n g i n e e r i n g , these t h e s e PROCESSES P R O C E S S E S have h a v e been b e e n omitted o m i t t e d from f r o m this t h i s standard. s t a n d a r d . These T h e s e PROCESSES P R O C E S S E S are a r e covered c o v e r e d by b y a a quality q u a l i t y management m a n a g e m e n t system. s y s t e m . ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] is i s an a n International I n t e r n a t i o n a l Standard S t a n d a r d that t h a t is i s specifically s p e c i f i c a l l y intended i n t e n d e d for f o r applying a p p l y i n g the t h e concepts c o n c e p t s of o f quality q u a l i t y management m a n a g e m e n t to t o MEDICAL M E D I C A L DEVICES. D E V I C E S . Conformance C o n f o r m a n c e to t o ISO I S O 13485 1 3 4 8 5 quality q u a l i t y management m a n a g e m e n t system s y s t e m requirements r e q u i r e m e n t s does d o e s not n o t automatically a u t o m a t i c a l l y constitute c o n s t i t u t e conformity c o n f o r m i t y with w i t h national n a t i o n a l or o r regional r e g i o n a l regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . It I t is i s the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S responsibility r e s p o n s i b i l i t y to t o identify i d e n t i f y and a n d establish e s t a b l i s h compliance c o m p l i a n c e with w i t h relevant r e l e v a n t regulatory r e g u l a t o r y requirements. r e q u i r e m e n t s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.4.2 B . 4 . 2 RISK R I S K MANAGEMENT M A N A G E M E N T Software S o f t w a r e development d e v e l o p m e n t participates p a r t i c i p a t e s in i n RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S sufficiently s u f f i c i e n t l y to t o ensure e n s u r e that t h a t all a l l reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E are a r e considered. c o n s i d e r e d . Rather R a t h e r than t h a n trying t r y i n g to t o define d e f i n e an a n appropriate a p p r o p r i a t e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s software s o f t w a r e engineering e n g i n e e r i n g standard, s t a n d a r d , it i t is i s required r e q u i r e d that t h a t the t h e MANUFACTURER M A N U F A C T U R E R apply a p p l y a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 41 4 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971, 1 4 9 7 1 , which w h i c h deals d e a l s explicitly e x p l i c i t l y with w i t h RISK R I S K MANAGEMENT M A N A G E M E N T for f o r MEDICAL M E D I C A L DEVICES. D E V I C E S . Specific S p e c i f i c software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S resulting r e s u l t i n g from f r o m HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t have h a v e software s o f t w a r e as a s a a contributing c o n t r i b u t i n g cause c a u s e are a r e identified i d e n t i f i e d in i n a a supporting s u p p o r t i n g PROCESS P R O C E S S described d e s c r i b e d in i n Clause C l a u s e 7. 7 . B.4.3 B . 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e RISK R I S K associated a s s o c i a t e d with w i t h software s o f t w a r e as a s a a part p a r t of o f a a MEDICAL M E D I C A L DEVICE, D E V I C E , as a s an a n accessory a c c e s s o r y to t o a a MEDICAL M E D I C A L DEVICE, D E V I C E , or o r as a s a a MEDICAL M E D I C A L DEVICE D E V I C E in i n its i t s own o w n right, r i g h t , is i s used u s e d as a s the t h e input i n p u t to t o a a software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme, s c h e m e , which w h i c h then t h e n determines d e t e r m i n e s the t h e PROCESSES P R O C E S S E S to t o be b e used u s e d during d u r i n g the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f software. s o f t w a r e . RISK R I S K is i s considered c o n s i d e r e d to t o be b e a a combination c o m b i n a t i o n of o f the t h e severity s e v e r i t y of o f HARM H A R M and a n d the t h e probability p r o b a b i l i t y of o f its i t s occurrence. o c c u r r e n c e . However, H o w e v e r , no n o consensus c o n s e n s u s exists e x i s t s for f o r a a method m e t h o d of o f quantitatively q u a n t i t a t i v e l y estimating e s t i m a t i n g the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f a a software s o f t w a r e failure. f a i l u r e . When W h e n software s o f t w a r e is i s present p r e s e n t in i n a a sequence s e q u e n c e or o r combination c o m b i n a t i o n of o f events e v e n t s leading l e a d i n g to t o a a HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , the t h e probability p r o b a b i l i t y of o f the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g cannot c a n n o t be b e considered c o n s i d e r e d in i n estimating e s t i m a t i n g the t h e RISK R I S K for f o r the t h e HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . In I n such s u c h cases, c a s e s , considering c o n s i d e r i n g a a worst w o r s t case c a s e probability p r o b a b i l i t y is i s appropriate, a p p r o p r i a t e , and a n d the t h e probability p r o b a b i l i t y for f o r the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g should s h o u l d be b e set s e t to t o 1. 1 . When W h e n it i t is i s possible p o s s i b l e to t o estimate e s t i m a t e the t h e probability p r o b a b i l i t y for f o r the t h e remaining r e m a i n i n g events e v e n t s in i n the t h e sequence s e q u e n c e (as ( a s it i t may m a y be b e if i f they t h e y are a r e not n o t software) s o f t w a r e ) that t h a t probability p r o b a b i l i t y can c a n be b e used u s e d for f o r the t h e probability p r o b a b i l i t y of o f the t h e HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N occurring o c c u r r i n g (P ( P 1 1 in i n Figure F i g u r e B.2). B . 2 ) . In I n many m a n y cases c a s e s however, h o w e v e r , it i t might m i g h t not n o t be b e possible p o s s i b l e to t o estimate e s t i m a t e the t h e probability p r o b a b i l i t y for f o r the t h e remaining r e m a i n i n g events e v e n t s in i n the t h e sequence, s e q u e n c e , and a n d the t h e RISK R I S K should s h o u l d be b e EVALUATED E V A L U A T E D on o n the t h e basis b a s i s of o f the t h e nature n a t u r e of o f the t h e HARM H A R M alone a l o n e (the ( t h e probability p r o b a b i l i t y of o f the t h e HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N occurring o c c u r r i n g should s h o u l d be b e set s e t to t o 1). 1 ) . RISK R I S K ESTIMATION E S T I M A T I O N in i n these t h e s e cases c a s e s should s h o u l d be b e focused f o c u s e d on o n the t h e SEVERITY S E V E R I T Y of o f the t h e HARM H A R M resulting r e s u l t i n g from f r o m the t h e HAZARDOUS H A Z A R D O U S SITUATION. S I T U A T I O N . Subjective S u b j e c t i v e rankings r a n k i n g s of o f probability p r o b a b i l i t y can c a n also a l s o be b e assigned a s s i g n e d based b a s e d on o n clinical c l i n i c a l knowledge k n o w l e d g e to t o distinguish d i s t i n g u i s h failures f a i l u r e s that t h a t a a clinician c l i n i c i a n would w o u l d be b e likely l i k e l y to t o detect d e t e c t from f r o m those t h o s e that t h a t would w o u l d not n o t be b e detected d e t e c t e d and a n d would w o u l d be b e more m o r e likely l i k e l y to t o cause c a u s e HARM. H A R M . Estimates E s t i m a t e s of o f probability p r o b a b i l i t y of o f a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N leading l e a d i n g to t o HARM H A R M (P ( P 2 2 in i n Figure F i g u r e B.2) B . 2 ) generally g e n e r a l l y require r e q u i r e clinical c l i n i c a l knowledge k n o w l e d g e to t o distinguish d i s t i n g u i s h between b e t w e e n HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S where w h e r e clinical c l i n i c a l practice p r a c t i c e would w o u l d be b e likely l i k e l y to t o prevent p r e v e n t HARM, H A R M , and a n d HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S that t h a t would w o u l d be b e more m o r e likely l i k e l y to t o cause c a u s e HARM. H A R M . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 42 4 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Sequence S e q u e n c e of o f events e v e n t s Hazard H a z a r d Hazardous H a z a r d o u s situation s i t u a t i o n Exposure E x p o s u r e (P1) ( P 1 ) P2 P 2 Harm H a r m Severity S e v e r i t y of o f the t h e harm h a r m Probability P r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f harm h a r m Risk R i s k P1 P 1 × × P2 P 2 NOTE N O T E P P 1 1 is i s the t h e probability p r o b a b i l i t y of o f a a hazardous h a z a r d o u s situation s i t u a t i o n occurring o c c u r r i n g IEC I E C P P 2 2 is i s the t h e probability p r o b a b i l i t y of o f a a hazardous h a z a r d o u s situation s i t u a t i o n leading l e a d i n g to t o harm h a r m Figure F i g u r e B.2 B . 2 – – Pictorial P i c t o r i a l representation r e p r e s e n t a t i o n of o f the t h e relationship r e l a t i o n s h i p of o f HAZARD, H A Z A R D , sequence s e q u e n c e of o f events, e v e n t s , HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , and a n d HARM H A R M – – from f r o m ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 Annex A n n e x E E If I f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s decomposed d e c o m p o s e d into i n t o SOFTWARE S O F T W A R E ITEMS, I T E M S , then t h e n each e a c h SOFTWARE S O F T W A R E ITEM I T E M can c a n have h a v e its i t s own o w n software s o f t w a r e safety s a f e t y classification. c l a s s i f i c a t i o n . It I t is i s only o n l y possible p o s s i b l e to t o determine d e t e r m i n e the t h e RISK R I S K associated a s s o c i a t e d with w i t h failure f a i l u r e of o f a a SOFTWARE S O F T W A R E ITEM: I T E M : – – if i f a a SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d a a software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E define d e f i n e the t h e role r o l e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M in i n terms t e r m s of o f its i t s purpose p u r p o s e and a n d its i t s interfaces i n t e r f a c e s with w i t h other o t h e r software s o f t w a r e and a n d hardware h a r d w a r e items; i t e m s ; – – if i f changes c h a n g e s to t o the t h e SYSTEM S Y S T E M are a r e controlled; c o n t r o l l e d ; – – after a f t e r RISK R I S K ANALYSIS A N A L Y S I S has h a s been b e e n done d o n e on o n the t h e ARCHITECTURE A R C H I T E C T U R E and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s specified. s p e c i f i e d . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e minimum m i n i m u m number n u m b e r of o f ACTIVITIES A C T I V I T I E S that t h a t will w i l l achieve a c h i e v e the t h e above a b o v e conditions c o n d i t i o n s for f o r all a l l classes c l a s s e s of o f software. s o f t w a r e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e end e n d of o f the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E ACTIVITY A C T I V I T Y is i s the t h e earliest e a r l i e s t point p o i n t in i n the t h e development d e v e l o p m e n t when w h e n the t h e full f u l l set s e t of o f SOFTWARE S O F T W A R E ITEMS I T E M S is i s defined d e f i n e d and a n d the t h e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITY A C T I V I T Y has h a s identified i d e n t i f i e d how h o w the t h e SOFTWARE S O F T W A R E ITEMS I T E M S relate r e l a t e to t o SAFETY. S A F E T Y . This T h i s is i s therefore t h e r e f o r e the t h e earliest e a r l i e s t point p o i n t at a t which w h i c h SOFTWARE S O F T W A R E ITEMS I T E M S can c a n be b e classified c l a s s i f i e d definitively d e f i n i t i v e l y according a c c o r d i n g to t o their t h e i r SAFETY S A F E T Y role. r o l e . This T h i s point p o i n t corresponds c o r r e s p o n d s to t o the t h e point p o i n t where w h e r e RISK R I S K CONTROL C O N T R O L is i s begun b e g u n in i n ISO I S O 14971. 1 4 9 7 1 . Before B e f o r e this t h i s point, p o i n t , the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S identifies i d e n t i f i e s ARCHITECTURAL A R C H I T E C T U R A L RISK R I S K CONTROL C O N T R O L measures, m e a s u r e s , for f o r example e x a m p l e adding a d d i n g protective p r o t e c t i v e subsystems, s u b s y s t e m s , or o r reducing r e d u c i n g the t h e opportunities o p p o r t u n i t i e s for f o r software s o f t w a r e failures f a i l u r e s to t o cause c a u s e HARM. H A R M . After A f t e r this t h i s point, p o i n t , the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S uses u s e s PROCESSES P R O C E S S E S aimed a i m e d at a t reducing r e d u c i n g the t h e probability p r o b a b i l i t y of o f failure f a i l u r e of o f SOFTWARE S O F T W A R E ITEMS. I T E M S . In I n other o t h e r words, w o r d s , the t h e classification c l a s s i f i c a t i o n of o f a a SOFTWARE S O F T W A R E ITEM I T E M specifies s p e c i f i e s PROCESS-based P R O C E S S - b a s e d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o be b e applied a p p l i e d to t o that t h a t item. i t e m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 43 4 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 It I t is i s expected e x p e c t e d that t h a t MANUFACTURERS M A N U F A C T U R E R S will w i l l find f i n d it i t useful u s e f u l to t o classify c l a s s i f y software s o f t w a r e before b e f o r e this t h i s point, p o i n t , for f o r example e x a m p l e to t o focus f o c u s attention a t t e n t i o n on o n areas a r e a s to t o be b e investigated, i n v e s t i g a t e d , but b u t such s u c h classification c l a s s i f i c a t i o n should s h o u l d be b e regarded r e g a r d e d as a s preliminary p r e l i m i n a r y and a n d should s h o u l d not n o t be b e used u s e d to t o justify j u s t i f y the t h e omission o m i s s i o n of o f PROCESSES. P R O C E S S E S . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme s c h e m e is i s not n o t intended i n t e n d e d to t o align a l i g n with w i t h the t h e RISK R I S K classifications c l a s s i f i c a t i o n s of o f ISO I S O 14971. 1 4 9 7 1 . Whereas W h e r e a s the t h e ISO I S O 14971 1 4 9 7 1 scheme s c h e m e classifies c l a s s i f i e s RISK R I S K according a c c o r d i n g to t o their t h e i r severity s e v e r i t y and a n d likelihood, l i k e l i h o o d , the t h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n scheme s c h e m e classifies c l a s s i f i e s SOFTWARE S O F T W A R E SYSTEMS S Y S T E M S and a n d SOFTWARE S O F T W A R E ITEMS I T E M S according a c c o r d i n g to t o the t h e PROCESSES P R O C E S S E S to t o be b e applied a p p l i e d in i n their t h e i r development d e v e l o p m e n t and a n d maintenance. m a i n t e n a n c e . As A s the t h e design d e s i g n evolves, e v o l v e s , new n e w RISKS R I S K S might m i g h t become b e c o m e evident. e v i d e n t . Therefore, T h e r e f o r e , RISK R I S K MANAGEMENT M A N A G E M E N T should s h o u l d be b e applied a p p l i e d as a s an a n integral i n t e g r a l part p a r t of o f the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . This T h i s permits p e r m i t s the t h e development d e v e l o p m e n t of o f an a n ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n that t h a t identifies i d e n t i f i e s a a complete c o m p l e t e set s e t of o f SOFTWARE S O F T W A R E ITEMS, I T E M S , including i n c l u d i n g those t h o s e that t h a t are a r e required r e q u i r e d to t o function f u n c t i o n correctly c o r r e c t l y to t o assure a s s u r e safe s a f e operation o p e r a t i o n and a n d those t h o s e that t h a t prevent p r e v e n t faults f a u l t s from f r o m causing c a u s i n g HARM. H A R M . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E should s h o u l d promote p r o m o t e segregation s e g r e g a t i o n of o f software s o f t w a r e items i t e m s that t h a t are a r e required r e q u i r e d for f o r safe s a f e operation o p e r a t i o n and a n d should s h o u l d describe d e s c r i b e the t h e methods m e t h o d s used u s e d to t o ensure e n s u r e effective e f f e c t i v e segregation s e g r e g a t i o n of o f those t h o s e SOFTWARE S O F T W A R E ITEMS. I T E M S . Segregation S e g r e g a t i o n is i s not n o t restricted r e s t r i c t e d to t o physical p h y s i c a l (processor ( p r o c e s s o r or o r memory m e m o r y partition) p a r t i t i o n ) separation s e p a r a t i o n but b u t includes i n c l u d e s any a n y mechanism m e c h a n i s m that t h a t prevents p r e v e n t s one o n e SOFTWARE S O F T W A R E ITEM I T E M from f r o m negatively n e g a t i v e l y affecting a f f e c t i n g another. a n o t h e r . The T h e adequacy a d e q u a c y of o f a a segregation s e g r e g a t i o n is i s determined d e t e r m i n e d based b a s e d on o n the t h e RISKS R I S K S involved i n v o l v e d and a n d the t h e rationale r a t i o n a l e which w h i c h is i s required r e q u i r e d to t o be b e documented. d o c u m e n t e d . As A s stated s t a t e d in i n B.3, B . 3 , this t h i s standard s t a n d a r d chooses c h o o s e s to t o use u s e three t h r e e terms t e r m s to t o describe d e s c r i b e the t h e decomposition d e c o m p o s i t i o n of o f a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (top ( t o p level). l e v e l ) . Figure F i g u r e B.1 B . 1 illustrates i l l u s t r a t e s the t h e possible p o s s i b l e partitioning p a r t i t i o n i n g for f o r SOFTWARE S O F T W A R E ITEMS I T E M S within w i t h i n a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d how h o w the t h e software s o f t w a r e safety s a f e t y classes c l a s s e s would w o u l d be b e applied a p p l i e d to t o the t h e group g r o u p of o f SOFTWARE S O F T W A R E ITEMS I T E M S in i n the t h e decomposition. d e c o m p o s i t i o n . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 44 4 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M / / SOFTWARE S O F T W A R E ITEM I T E M (CLASS ( C L A S S C) C ) SOFTWARE S O F T W A R E ITEM I T E M X X (Class ( C l a s s A) A ) SOFTWARE S O F T W A R E ITEM I T E M Y Y (Class ( C l a s s C) C ) SOFTWARE S O F T W A R E ITEM I T E M W W (Class ( C l a s s B) B ) SOFTWARE S O F T W A R E ITEM I T E M Z Z (Class ( C l a s s C) C ) IEC I E C 724/06 7 2 4 / 0 6 Figure F i g u r e B.1 B . 1 – – Example E x a m p l e of o f partitioning p a r t i t i o n i n g of o f SOFTWARE S O F T W A R E ITEMS I T E M S For F o r this t h i s example, e x a m p l e , the t h e MANUFACTURER M A N U F A C T U R E R knows, k n o w s , due d u e to t o the t h e type t y p e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E being b e i n g developed, d e v e l o p e d , that t h a t the t h e preliminary p r e l i m i n a r y software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n for f o r the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s software s o f t w a r e safety s a f e t y class c l a s s C. C . During D u r i n g software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E design d e s i g n the t h e MANUFACTURER M A N U F A C T U R E R has h a s decided d e c i d e d to t o partition p a r t i t i o n the t h e SYSTEM, S Y S T E M , as a s shown, s h o w n , with w i t h 3 3 SOFTWARE S O F T W A R E ITEMS I T E M S – – X, X , W W and a n d Z. Z . The T h e MANUFACTURER M A N U F A C T U R E R is i s able a b l e to t o segregate s e g r e g a t e all a l l SOFTWARE S O F T W A R E SYSTEM S Y S T E M contributions c o n t r i b u t i o n s to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h could c o u l d result r e s u l t in i n death d e a t h or o r SERIOUS S E R I O U S INJURY I N J U R Y to t o SOFTWARE S O F T W A R E ITEM I T E M Z Z and a n d all a l l remaining r e m a i n i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M contributions c o n t r i b u t i o n s to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h could c o u l d result r e s u l t in i n a a non-SERIOUS n o n - S E R I O U S INJURY I N J U R Y to t o SOFTWARE S O F T W A R E ITEM I T E M W. W . SOFTWARE S O F T W A R E ITEm I T E m W W is i s classified c l a s s i f i e d as a s software s o f t w a r e safety s a f e t y class c l a s s B B and a n d SOFTWARE S O F T W A R E ITEM I T E M Z Z is i s at a t software s o f t w a r e safety s a f e t y class c l a s s C. C . SOFTWARE S O F T W A R E ITEM I T E M Y Y therefore t h e r e f o r e must m u s t be b e classified c l a s s i f i e d as a s Class C l a s s C, C , per p e r 4.3 4 . 3 d). d ) . The T h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s also a l s o at a t a a software s o f t w a r e safety s a f e t y class c l a s s C C per p e r this t h i s requirement. r e q u i r e m e n t . SOFTWARE S O F T W A R E ITEM I T E M X X has h a s been b e e n classified c l a s s i f i e d at a t a a software s o f t w a r e safety s a f e t y class c l a s s of o f A. A . The T h e MANUFACTURER M A N U F A C T U R E R is i s able a b l e to t o document d o c u m e n t a a rationale r a t i o n a l e for f o r the t h e segregation s e g r e g a t i o n between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S X X and a n d Y, Y , as a s well w e l l as a s SOFTWARE S O F T W A R E ITEMS I T E M S W W and a n d Z, Z , to t o assure a s s u r e the t h e integrity i n t e g r i t y of o f the t h e segregation. s e g r e g a t i o n . If I f segregation s e g r e g a t i o n is i s not n o t possible p o s s i b l e between b e t w e e n SOFTWARE S O F T W A R E ITEMS I T E M S X X and a n d Y, Y , then t h e n SOFTWARE S O F T W A R E ITEM I T E M X X must m u s t be b e classified c l a s s i f i e d in i n software s o f t w a r e safety s a f e t y class c l a s s C. C . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.4.4 B . 4 . 4 LEGACY L E G A C Y SOFTWARE S O F T W A R E Subclause S u b c l a u s e 4.4 4 . 4 establishes e s t a b l i s h e s a a process p r o c e s s for f o r application a p p l i c a t i o n of o f this t h i s standard s t a n d a r d to t o LEGACY L E G A C Y SOFTWARE. S O F T W A R E . Some S o m e geographies g e o g r a p h i e s may m a y require r e q u i r e the t h e MANUFACTURER M A N U F A C T U R E R to t o show s h o w conformity c o n f o r m i t y to t o the t h e standard s t a n d a r d to t o obtain o b t a i n regulatory r e g u l a t o r y approval a p p r o v a l of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , even e v e n if i f that t h a t software s o f t w a r e was w a s designed d e s i g n e d prior p r i o r to t o the t h e existence e x i s t e n c e of o f the t h e current c u r r e n t version v e r s i o n of o f the t h e standard s t a n d a r d (LEGACY ( L E G A C Y SOFTWARE). S O F T W A R E ) . In I n this t h i s case, c a s e , the t h e requirements r e q u i r e m e n t s in i n 4.4 4 . 4 provide p r o v i d e a a method m e t h o d for f o r the t h e the t h e MANUFACTURER M A N U F A C T U R E R to t o demonstrate d e m o n s t r a t e compliance c o m p l i a n c e of o f LEGACY L E G A C Y SOFTWARE S O F T W A R E to t o the t h e standard. s t a n d a r d . A A MANUFACTURER M A N U F A C T U R E R may m a y determine d e t e r m i n e that t h a t retrospective r e t r o s p e c t i v e documentation d o c u m e n t a t i o n of o f an a n already a l r e a d y finished f i n i s h e d development-lifecycle d e v e l o p m e n t - l i f e c y c l e performed p e r f o r m e d as a s an a n isolated i s o l a t e d activity a c t i v i t y does d o e s not n o t result r e s u l t in i n the t h e reduction r e d u c t i o n of o f RISK R I S K associated a s s o c i a t e d with w i t h the t h e use u s e of o f the t h e product. p r o d u c t . The T h e process p r o c e s s results r e s u l t s in i n the t h e identification i d e n t i f i c a t i o n of o f a a subset s u b s e t of o f granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 45 4 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ACTIVITIES A C T I V I T I E S defined d e f i n e d in i n this t h i s standard s t a n d a r d which w h i c h does d o e s result r e s u l t in i n reduction r e d u c t i o n of o f RISK. R I S K . Some S o m e additional a d d i t i o n a l goals g o a l s implicit i m p l i c i t in i n the t h e process p r o c e s s are: a r e : – – required r e q u i r e d ACTIVITIES A C T I V I T I E S and a n d resulting r e s u l t i n g documentation d o c u m e n t a t i o n should s h o u l d rely r e l y on o n and a n d make m a k e use u s e of, o f , wherever w h e r e v e r possible, p o s s i b l e , existing e x i s t i n g documentation, d o c u m e n t a t i o n , and a n d – – a a MANUFACTURER M A N U F A C T U R E R should s h o u l d utilize u t i l i z e resources r e s o u r c e s as a s effectively e f f e c t i v e l y as a s possible p o s s i b l e to t o effect e f f e c t a a reduction r e d u c t i o n of o f RISK. R I S K . In I n addition a d d i t i o n to t o a a plan p l a n identifying i d e n t i f y i n g the t h e subset s u b s e t of o f ACTIVITIES A C T I V I T I E S to t o execute, e x e c u t e , the t h e process p r o c e s s also a l s o results r e s u l t s in i n objective o b j e c t i v e evidence e v i d e n c e supporting s u p p o r t i n g safe s a f e continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d a a summary s u m m a r y rationale r a t i o n a l e for f o r this t h i s conclusion. c o n c l u s i o n . The T h e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e planned p l a n n e d continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E depend d e p e n d on o n the t h e context c o n t e x t in i n which w h i c h the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e used u s e d to t o create c r e a t e a a SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . The T h e MANUFACTURER M A N U F A C T U R E R will w i l l document d o c u m e n t all a l l identified i d e n t i f i e d MEDICAL M E D I C A L DEVICE D E V I C E HAZARDS H A Z A R D S associated a s s o c i a t e d with w i t h the t h e LEGACY L E G A C Y SOFTWARE. S O F T W A R E . Subclause S u b c l a u s e 4.4 4 . 4 requires r e q u i r e s a a comprehensive c o m p r e h e n s i v e assessment a s s e s s m e n t of o f available a v a i l a b l e post-production p o s t - p r o d u c t i o n field f i e l d data d a t a obtained o b t a i n e d for f o r the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E during d u r i n g the t h e time t i m e it i t has h a s been b e e n in i n production p r o d u c t i o n and a n d use. u s e . Typical T y p i c a l sources s o u r c e s of o f post- p o s t - production p r o d u c t i o n data d a t a include: i n c l u d e : – – adverse a d v e r s e events e v e n t s attributable a t t r i b u t a b l e to t o the t h e device, d e v i c e , – – feedback f e e d b a c k received r e c e i v e d from f r o m users u s e r s of o f the t h e device, d e v i c e , and a n d – – ANOMALIES A N O M A L I E S discovered d i s c o v e r e d by b y the t h e MANUFACTURER. M A N U F A C T U R E R . Though T h o u g h no n o consensus c o n s e n s u s exists e x i s t s for f o r a a method m e t h o d of o f prospectively p r o s p e c t i v e l y estimating e s t i m a t i n g quantitatively q u a n t i t a t i v e l y the t h e probability p r o b a b i l i t y of o f occurrence o c c u r r e n c e of o f a a software s o f t w a r e failure, f a i l u r e , such s u c h information i n f o r m a t i o n may m a y be b e available a v a i l a b l e for f o r LEGACY L E G A C Y SOFTWARE, S O F T W A R E , based b a s e d on o n the t h e usage u s a g e of o f such s u c h software s o f t w a r e and a n d EVALUATION E V A L U A T I O N of o f post-production p o s t - p r o d u c t i o n data. d a t a . If I f it i t is i s possible p o s s i b l e in i n such s u c h cases c a s e s to t o quantitatively q u a n t i t a t i v e l y estimate e s t i m a t e the t h e probability p r o b a b i l i t y of o f events e v e n t s in i n the t h e sequence, s e q u e n c e , a a quantitative q u a n t i t a t i v e value v a l u e may m a y be b e used u s e d for f o r expressing e x p r e s s i n g the t h e probability p r o b a b i l i t y of o f the t h e entire e n t i r e sequence s e q u e n c e of o f events e v e n t s occurring. o c c u r r i n g . If I f such s u c h quantitative q u a n t i t a t i v e estimation e s t i m a t i o n is i s not n o t possible, p o s s i b l e , considering c o n s i d e r i n g a a worst w o r s t case c a s e probability p r o b a b i l i t y is i s appropriate, a p p r o p r i a t e , and a n d the t h e probability p r o b a b i l i t y for f o r the t h e software s o f t w a r e failure f a i l u r e occurring o c c u r r i n g should s h o u l d be b e assumed a s s u m e d to t o be b e 1. 1 . The T h e MANUFACTURER M A N U F A C T U R E R determination d e t e r m i n a t i o n of o f how h o w the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e used u s e d in i n the t h e overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E is i s input i n p u t to t o the t h e assessment a s s e s s m e n t of o f RISK. R I S K . The T h e RISKS R I S K S to t o be b e considered c o n s i d e r e d vary v a r y accordingly. a c c o r d i n g l y . – – When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E has h a s been b e e n safely s a f e l y and a n d reliably r e l i a b l y used u s e d and a n d the t h e MANUFACTURER M A N U F A C T U R E R wishes w i s h e s to t o continue c o n t i n u e use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e rationale r a t i o n a l e for f o r continued c o n t i n u e d use u s e rests r e s t s primarily p r i m a r i l y on o n the t h e assessment a s s e s s m e n t of o f RISK R I S K based b a s e d on o n post-production p o s t - p r o d u c t i o n records. r e c o r d s . – – When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E is i s reused r e u s e d to t o create c r e a t e a a new n e w SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , the t h e intended i n t e n d e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E might m i g h t be b e different d i f f e r e n t from f r o m its i t s original o r i g i n a l intended i n t e n d e d use. u s e . In I n this t h i s case c a s e the t h e RISK R I S K assessment a s s e s s m e n t must m u s t take t a k e into i n t o account a c c o u n t the t h e modified m o d i f i e d set s e t of o f HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S which w h i c h can c a n arise a r i s e due d u e to t o failures f a i l u r e s of o f the t h e LEGACY L E G A C Y SOFTWARE. S O F T W A R E . – – A A reused r e u s e d LEGACY L E G A C Y SOFTWARE S O F T W A R E may m a y be b e used u s e d for f o r similar s i m i l a r intended i n t e n d e d use u s e but b u t integrated i n t e g r a t e d into i n t o a a new n e w SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . In I n this t h i s case c a s e the t h e RISK R I S K assessment a s s e s s m e n t should s h o u l d take t a k e into i n t o account a c c o u n t modification m o d i f i c a t i o n of o f architectural a r c h i t e c t u r a l RISK R I S K CONTROL C O N T R O L measures m e a s u r e s according a c c o r d i n g to t o 5.3. 5 . 3 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . When W h e n LEGACY L E G A C Y SOFTWARE S O F T W A R E will w i l l be b e changed c h a n g e d and a n d used u s e d within w i t h i n a a new n e w SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d consider c o n s i d e r how h o w the t h e existing e x i s t i n g records r e c o r d s of o f safe s a f e and a n d reliable r e l i a b l e operation o p e r a t i o n may m a y be b e invalidated i n v a l i d a t e d by b y the t h e changes. c h a n g e s . Changes C h a n g e s to t o the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E should s h o u l d be b e performed p e r f o r m e d according a c c o r d i n g to t o Clauses C l a u s e s 4 4 to t o 9 9 of o f this t h i s standard, s t a n d a r d , including i n c l u d i n g assessment a s s e s s m e n t of o f impact i m p a c t to t o RISK R I S K CONTROL C O N T R O L measures m e a s u r e s according a c c o r d i n g to t o 7.4. 7 . 4 . In I n the t h e case c a s e of o f LEGACY L E G A C Y SOFTWARE, S O F T W A R E , existing e x i s t i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s may m a y not n o t be b e fully f u l l y documented d o c u m e n t e d and a n d special s p e c i a l care c a r e should s h o u l d be b e taken t a k e n to t o EVALUATE E V A L U A T E the t h e potential p o t e n t i a l impact i m p a c t of o f changes, c h a n g e s , utilizing u t i l i z i n g available a v a i l a b l e documented d o c u m e n t e d design d e s i g n records r e c o r d s as a s well w e l l as a s expertise e x p e r t i s e of o f individuals i n d i v i d u a l s having h a v i n g knowledge k n o w l e d g e of o f the t h e system. s y s t e m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 46 4 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 According A c c o r d i n g to t o 4.4, 4 . 4 , the t h e MANUFACTURER M A N U F A C T U R E R performs p e r f o r m s a a gap g a p analysis a n a l y s i s in i n order o r d e r to t o determine d e t e r m i n e the t h e available a v a i l a b l e documentation d o c u m e n t a t i o n including i n c l u d i n g objective o b j e c t i v e evidence e v i d e n c e of o f performed p e r f o r m e d TASKS T A S K S done d o n e during d u r i n g development d e v e l o p m e n t of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d compared c o m p a r e d to t o 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7. 7 . Typical T y p i c a l steps s t e p s to t o accomplish a c c o m p l i s h this t h i s gap g a p analysis a n a l y s i s include i n c l u d e identification i d e n t i f i c a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , including i n c l u d i n g VERSION, V E R S I O N , revision r e v i s i o n and a n d any a n y other o t h e r means, m e a n s , required r e q u i r e d for f o r clear c l e a r identification; i d e n t i f i c a t i o n ; EVALUATION E V A L U A T I O N of o f existing e x i s t i n g DELIVERABLES D E L I V E R A B L E S corresponding c o r r e s p o n d i n g to t o the t h e deliverables d e l i v e r a b l e s required r e q u i r e d by b y 5.2, 5 . 2 , 5.3, 5 . 3 , 5.7, 5 . 7 , and a n d Clause C l a u s e 7; 7 ; EVALUATION E V A L U A T I O N of o f available a v a i l a b l e objective o b j e c t i v e evidence, e v i d e n c e , documenting d o c u m e n t i n g the t h e previously p r e v i o u s l y applied a p p l i e d software s o f t w a r e development d e v e l o p m e n t lifecycle l i f e c y c l e model m o d e l (as ( a s appropriate); a p p r o p r i a t e ) ; EVALUATION E V A L U A T I O N of o f the t h e adequacy a d e q u a c y of o f existing e x i s t i n g RISK R I S K MANAGEMENT M A N A G E M E N T documentation, d o c u m e n t a t i o n , taking t a k i n g ISO I S O 14971 1 4 9 7 1 into i n t o account. a c c o u n t . Taking T a k i n g the t h e performed p e r f o r m e d gap g a p analysis a n a l y s i s into i n t o account, a c c o u n t , the t h e MANUFACTURER M A N U F A C T U R E R will w i l l EVALUATE E V A L U A T E the t h e potential p o t e n t i a l reduction r e d u c t i o n in i n RISK R I S K resulting r e s u l t i n g from f r o m the t h e generation g e n e r a t i o n of o f the t h e missing m i s s i n g DELIVERABLES D E L I V E R A B L E S and a n d associated a s s o c i a t e d ACTIVITIES, A C T I V I T I E S , and a n d create c r e a t e a a plan p l a n to t o perform p e r f o r m ACTIVITIES A C T I V I T I E S and a n d generate g e n e r a t e DELIVERABLES D E L I V E R A B L E S to t o close c l o s e these t h e s e gaps. g a p s . Reduction R e d u c t i o n of o f RISK R I S K should s h o u l d balance b a l a n c e the t h e benefit b e n e f i t of o f applying a p p l y i n g the t h e software s o f t w a r e development d e v e l o p m e n t process p r o c e s s according a c c o r d i n g to t o Clause C l a u s e 5 5 against a g a i n s t the t h e possibility p o s s i b i l i t y that t h a t modification m o d i f i c a t i o n of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E without w i t h o u t full f u l l knowledge k n o w l e d g e of o f its i t s development d e v e l o p m e n t history h i s t o r y could c o u l d introduce i n t r o d u c e new n e w defects d e f e c t s that t h a t increase i n c r e a s e the t h e risk. r i s k . Some S o m e of o f the t h e elements e l e m e n t s of o f Clause C l a u s e 5 5 may m a y be b e assessed a s s e s s e d to t o have h a v e little l i t t l e to t o no n o reduction r e d u c t i o n of o f RISK R I S K when w h e n done d o n e after a f t e r the t h e fact. f a c t . For F o r example, e x a m p l e , detailed d e t a i l e d design d e s i g n and a n d unit u n i t verification v e r i f i c a t i o n reduce r e d u c e RISK R I S K primarily p r i m a r i l y during d u r i n g the t h e process p r o c e s s of o f developing d e v e l o p i n g new n e w software s o f t w a r e or o r refactoring r e f a c t o r i n g existing e x i s t i n g software. s o f t w a r e . If I f these t h e s e objectives o b j e c t i v e s are a r e not n o t planned, p l a n n e d , performing p e r f o r m i n g the t h e ACTIVITIES A C T I V I T I E S in i n isolation i s o l a t i o n may m a y create c r e a t e documentation d o c u m e n t a t i o n but b u t lead l e a d to t o no n o reduction r e d u c t i o n in i n RISK. R I S K . At A t a a minimum, m i n i m u m , the t h e gap g a p closure c l o s u r e plan p l a n addresses a d d r e s s e s missing m i s s i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t records. r e c o r d s . If I f these t h e s e do d o not n o t exist e x i s t or o r are a r e not n o t suitable s u i t a b l e to t o support s u p p o r t a a rationale r a t i o n a l e to t o continue c o n t i n u e use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e gap g a p closure c l o s u r e plan p l a n should s h o u l d include i n c l u d e creation c r e a t i o n of o f SOFTWARE S O F T W A R E SYSTEM S Y S T E M requirements r e q u i r e m e n t s at a t a a functional f u n c t i o n a l level l e v e l according a c c o r d i n g to t o 5.2 5 . 2 and a n d tests t e s t s according a c c o r d i n g to t o 5.7. 5 . 7 . The T h e documented d o c u m e n t e d rationale r a t i o n a l e for f o r continued c o n t i n u e d use u s e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E builds b u i l d s on o n the t h e available a v a i l a b l e objective o b j e c t i v e evidence e v i d e n c e and a n d analysis a n a l y s i s obtained o b t a i n e d in i n the t h e course c o u r s e of o f assessing a s s e s s i n g the t h e RISK R I S K and a n d creating c r e a t i n g a a gap g a p closure c l o s u r e plan p l a n appropriate a p p r o p r i a t e for f o r the t h e context c o n t e x t of o f LEGACY L E G A C Y SOFTARE S O F T A R E reuse. r e u s e . The T h e rationale r a t i o n a l e makes m a k e s a a positive p o s i t i v e case c a s e for f o r the t h e safe s a f e and a n d reliable r e l i a b l e performace p e r f o r m a c e of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E in i n the t h e planned p l a n n e d reuse r e u s e context, c o n t e x t , taking t a k i n g into i n t o account a c c o u n t both b o t h the t h e post-production p o s t - p r o d u c t i o n records r e c o r d s available a v a i l a b l e for f o r the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d the t h e RISK R I S K CONTROL C O N T R O L MEASURES M E A S U R E S affected a f f e c t e d by b y filling f i l l i n g process p r o c e s s gaps. g a p s . After A f t e r LEGACY L E G A C Y SOFTWARE S O F T W A R E has h a s been b e e n re-used r e - u s e d according a c c o r d i n g to t o 4.4, 4 . 4 , those t h o s e parts p a r t s of o f the t h e LEGACY L E G A C Y SOFTWARE S O F T W A R E for f o r which w h i c h gaps g a p s in i n DELIVERABLES D E L I V E R A B L E S remain, r e m a i n , continue c o n t i n u e to t o be b e LEGACY L E G A C Y SOFTWARE S O F T W A R E and a n d may m a y be b e considered c o n s i d e r e d for f o r further f u r t h e r re-use r e - u s e again a g a i n according a c c o r d i n g to t o 4.4. 4 . 4 . When W h e n gaps g a p s in i n deliverables d e l i v e r a b l e s are a r e closed c l o s e d by b y changing c h a n g i n g the t h e LEGACY L E G A C Y SOFTWARE, S O F T W A R E , the t h e changes c h a n g e s should s h o u l d be b e performed p e r f o r m e d according a c c o r d i n g to t o Clauses C l a u s e s 4 4 to t o 9 9 of o f this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5 B . 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S B.5.1 B . 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g The T h e objective o b j e c t i v e of o f this t h i s ACTIVITY A C T I V I T Y is i s to t o plan p l a n the t h e software s o f t w a r e development d e v e l o p m e n t TASKS T A S K S to t o reduce r e d u c e RISKS R I S K S caused c a u s e d by b y software, s o f t w a r e , communicate c o m m u n i c a t e procedures p r o c e d u r e s and a n d goals g o a l s to t o members m e m b e r s of o f the t h e development d e v e l o p m e n t team, t e a m , and a n d ensure e n s u r e that t h a t SYSTEM S Y S T E M quality q u a l i t y requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E are a r e met. m e t . The T h e software s o f t w a r e development d e v e l o p m e n t planning p l a n n i n g ACTIVITY A C T I V I T Y can c a n document d o c u m e n t TASKS T A S K S in i n a a single s i n g l e plan p l a n or o r in i n multiple m u l t i p l e plans. p l a n s . Some S o m e MANUFACTURERS M A N U F A C T U R E R S might m i g h t have h a v e established e s t a b l i s h e d policies p o l i c i e s and a n d procedures p r o c e d u r e s that t h a t apply a p p l y to t o the t h e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 47 4 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 development d e v e l o p m e n t of o f all a l l their t h e i r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . In I n this t h i s case c a s e the t h e plan p l a n can c a n simply s i m p l y reference r e f e r e n c e the t h e existing e x i s t i n g policies p o l i c i e s and a n d procedures. p r o c e d u r e s . Some S o m e MANUFACTURERS M A N U F A C T U R E R S might m i g h t prepare p r e p a r e a a plan p l a n or o r set s e t of o f plans p l a n s specific s p e c i f i c to t o the t h e development d e v e l o p m e n t of o f each e a c h MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E that t h a t spell s p e l l out o u t in i n detail d e t a i l specific s p e c i f i c ACTIVITIES A C T I V I T I E S and a n d reference r e f e r e n c e general g e n e r a l procedures. p r o c e d u r e s . Another A n o t h e r possibility p o s s i b i l i t y is i s that t h a t a a plan p l a n or o r set s e t of o f plans p l a n s is i s tailored t a i l o r e d for f o r the t h e development d e v e l o p m e n t of o f each e a c h MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . The T h e planning p l a n n i n g should s h o u l d be b e specified s p e c i f i e d at a t the t h e level l e v e l of o f detail d e t a i l necessary n e c e s s a r y to t o carry c a r r y out o u t the t h e development d e v e l o p m e n t PROCESS P R O C E S S and a n d should s h o u l d be b e proportional p r o p o r t i o n a l to t o the t h e RISK. R I S K . For F o r example, e x a m p l e , SYSTEMS S Y S T E M S or o r items i t e m s with w i t h higher h i g h e r RISK R I S K would w o u l d be b e subject s u b j e c t to t o a a development d e v e l o p m e n t PROCESS P R O C E S S with w i t h more m o r e rigor r i g o r and a n d TASKS T A S K S should s h o u l d be b e spelled s p e l l e d out o u t in i n greater g r e a t e r detail. d e t a i l . Planning P l a n n i n g is i s an a n iterative i t e r a t i v e ACTIVITY A C T I V I T Y that t h a t should s h o u l d be b e re-examined r e - e x a m i n e d and a n d updated u p d a t e d as a s development d e v e l o p m e n t progresses. p r o g r e s s e s . The T h e plan p l a n can c a n evolve e v o l v e to t o incorporate i n c o r p o r a t e more m o r e and a n d better b e t t e r information i n f o r m a t i o n as a s more m o r e is i s understood u n d e r s t o o d about a b o u t the t h e SYSTEM S Y S T E M and a n d the t h e level l e v e l of o f effort e f f o r t needed n e e d e d to t o develop d e v e l o p the t h e SYSTEM. S Y S T E M . For F o r example, e x a m p l e , a a SYSTEM’s S Y S T E M ’ s initial i n i t i a l software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n can c a n change c h a n g e as a s a a result r e s u l t of o f exercising e x e r c i s i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S and a n d development d e v e l o p m e n t of o f the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . Or O r it i t might m i g h t be b e decided d e c i d e d that t h a t a a SOUP S O U P be b e incorporated i n c o r p o r a t e d into i n t o the t h e SYSTEM. S Y S T E M . It I t is i s important i m p o r t a n t that t h a t the t h e plan(s) p l a n ( s ) be b e updated u p d a t e d to t o reflect r e f l e c t current c u r r e n t knowledge k n o w l e d g e of o f the t h e SYSTEM S Y S T E M and a n d the t h e level l e v e l of o f rigor r i g o r needed n e e d e d for f o r the t h e SYSTEM S Y S T E M or o r items i t e m s in i n the t h e SYSTEM S Y S T E M to t o enable e n a b l e proper p r o p e r control c o n t r o l over o v e r the t h e development d e v e l o p m e n t PROCESS. P R O C E S S . B.5.2 B . 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o establish e s t a b l i s h and a n d verify v e r i f y the t h e software s o f t w a r e requirements r e q u i r e m e n t s for f o r the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Establishing E s t a b l i s h i n g verifiable v e r i f i a b l e requirements r e q u i r e m e n t s is i s essential e s s e n t i a l for f o r determining d e t e r m i n i n g what w h a t is i s to t o be b e built, b u i l t , for f o r determining d e t e r m i n i n g that t h a t the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E exhibits e x h i b i t s acceptable a c c e p t a b l e behaviour, b e h a v i o u r , and a n d for f o r demonstrating d e m o n s t r a t i n g that t h a t the t h e completed c o m p l e t e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s ready r e a d y for f o r use. u s e . To T o demonstrate d e m o n s t r a t e that t h a t the t h e requirements r e q u i r e m e n t s have h a v e been b e e n implemented i m p l e m e n t e d as a s desired, d e s i r e d , each e a c h requirement r e q u i r e m e n t should s h o u l d be b e stated s t a t e d in i n such s u c h a a way w a y that t h a t objective o b j e c t i v e criteria c r i t e r i a can c a n be b e established e s t a b l i s h e d to t o determine d e t e r m i n e whether w h e t h e r it i t has h a s been b e e n implemented i m p l e m e n t e d correctly. c o r r e c t l y . If I f the t h e device d e v i c e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S imposes i m p o s e s requirements r e q u i r e m e n t s on o n the t h e software s o f t w a r e to t o control c o n t r o l identified i d e n t i f i e d RISKS, R I S K S , these t h e s e requirements r e q u i r e m e n t s are a r e to t o be b e identified i d e n t i f i e d in i n the t h e software s o f t w a r e requirements r e q u i r e m e n t s in i n such s u c h a a way w a y as a s to t o make m a k e it i t possible p o s s i b l e to t o trace t r a c e the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . All A l l software s o f t w a r e requirements r e q u i r e m e n t s should s h o u l d be b e identified i d e n t i f i e d in i n such s u c h a a way w a y as a s to t o make m a k e it i t possible p o s s i b l e to t o demonstrate d e m o n s t r a t e TRACEABILITY T R A C E A B I L I T Y between b e t w e e n the t h e requirement r e q u i r e m e n t and a n d SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing. t e s t i n g . If I f regulatory r e g u l a t o r y approval a p p r o v a l in i n some s o m e countries c o u n t r i e s requires r e q u i r e s conformance c o n f o r m a n c e to t o specific s p e c i f i c regulations r e g u l a t i o n s or o r international i n t e r n a t i o n a l standards, s t a n d a r d s , this t h i s conformance c o n f o r m a n c e requirement r e q u i r e m e n t should s h o u l d be b e documented d o c u m e n t e d in i n the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . Because B e c a u s e the t h e software s o f t w a r e requirements r e q u i r e m e n t s establish e s t a b l i s h what w h a t is i s to t o be b e implemented i m p l e m e n t e d in i n the t h e software, s o f t w a r e , an a n evaluation e v a l u a t i o n of o f the t h e requirements r e q u i r e m e n t s is i s required r e q u i r e d before b e f o r e the t h e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY A C T I V I T Y is i s complete. c o m p l e t e . An A n area a r e a of o f frequent f r e q u e n t confusion c o n f u s i o n is i s the t h e distinction d i s t i n c t i o n between b e t w e e n customer c u s t o m e r needs, n e e d s , design d e s i g n inputs, i n p u t s , software s o f t w a r e requirements, r e q u i r e m e n t s , software s o f t w a r e functional f u n c t i o n a l specifications, s p e c i f i c a t i o n s , and a n d software s o f t w a r e design d e s i g n specifications. s p e c i f i c a t i o n s . Design D e s i g n inputs i n p u t s are a r e the t h e interpretation i n t e r p r e t a t i o n of o f customer c u s t o m e r needs n e e d s into i n t o formally f o r m a l l y documented d o c u m e n t e d MEDICAL M E D I C A L DEVICE D E V I C E requirements. r e q u i r e m e n t s . Software S o f t w a r e requirements r e q u i r e m e n t s are a r e the t h e formally f o r m a l l y documented d o c u m e n t e d specifications s p e c i f i c a t i o n s of o f what w h a t the t h e software s o f t w a r e does d o e s to t o meet m e e t the t h e customer c u s t o m e r needs n e e d s and a n d the t h e design d e s i g n inputs. i n p u t s . Software S o f t w a r e functional f u n c t i o n a l specifications s p e c i f i c a t i o n s are a r e often o f t e n included i n c l u d e d with w i t h the t h e software s o f t w a r e requirements r e q u i r e m e n t s and a n d define d e f i n e in i n detail d e t a i l what w h a t the t h e software s o f t w a r e does d o e s to t o meet m e e t its i t s requirements r e q u i r e m e n t s even e v e n though t h o u g h many m a n y different d i f f e r e n t alternatives a l t e r n a t i v e s might m i g h t also a l s o meet m e e t the t h e requirements. r e q u i r e m e n t s . Software S o f t w a r e design d e s i g n specifications s p e c i f i c a t i o n s define d e f i n e how h o w the t h e software s o f t w a r e will w i l l be b e designed d e s i g n e d and a n d decomposed d e c o m p o s e d to t o implement i m p l e m e n t its i t s requirements r e q u i r e m e n t s and a n d functional f u n c t i o n a l specifications. s p e c i f i c a t i o n s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Traditionally, T r a d i t i o n a l l y , software s o f t w a r e requirements, r e q u i r e m e n t s , functional f u n c t i o n a l specifications, s p e c i f i c a t i o n s , and a n d design d e s i g n specifications s p e c i f i c a t i o n s have h a v e been b e e n written w r i t t e n as a s a a set s e t of o f one o n e or o r more m o r e documents. d o c u m e n t s . It I t is i s now n o w feasible f e a s i b l e to t o consider c o n s i d e r this t h i s information i n f o r m a t i o n as a s data d a t a items i t e m s within w i t h i n a a common c o m m o n database. d a t a b a s e . Each E a c h item i t e m would w o u l d have h a v e one o n e or o r more m o r e attributes a t t r i b u t e s that t h a t would w o u l d define d e f i n e its i t s purpose p u r p o s e and a n d linkage l i n k a g e to t o other o t h e r items i t e m s in i n the t h e database. d a t a b a s e . This T h i s approach a p p r o a c h allows a l l o w s presentation p r e s e n t a t i o n and a n d printing p r i n t i n g of o f different d i f f e r e n t views v i e w s of o f the t h e information i n f o r m a t i o n best b e s t suited s u i t e d for f o r each e a c h set s e t of o f intended i n t e n d e d users u s e r s (e.g., ( e . g . , marketing, m a r k e t i n g , MANUFACTURERS, M A N U F A C T U R E R S , testers, t e s t e r s , auditors) a u d i t o r s ) and a n d supports s u p p o r t s TRACEABILITY T R A C E A B I L I T Y to t o demonstrate d e m o n s t r a t e adequate a d e q u a t e implementation i m p l e m e n t a t i o n and a n d the t h e extent e x t e n t to t o which w h i c h test t e s t cases c a s e s test t e s t the t h e requirements. r e q u i r e m e n t s . Tools T o o l s to t o support s u p p o r t this t h i s approach a p p r o a c h can c a n be b e as a s simple s i m p l e as a s a a hypertext h y p e r t e x t document d o c u m e n t using u s i n g HTML H T M L hyperlinks h y p e r l i n k s or o r as a s complex c o m p l e x and a n d capable c a p a b l e as a s computer c o m p u t e r aided a i d e d software s o f t w a r e engineering e n g i n e e r i n g (CASE) ( C A S E ) tools t o o l s and a n d requirements r e q u i r e m e n t s analysis a n a l y s i s tools. t o o l s . The T h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s PROCESS P R O C E S S is i s out o u t of o f scope s c o p e of o f this t h i s standard. s t a n d a r d . However, H o w e v e r , the t h e decision d e c i s i o n to t o implement i m p l e m e n t MEDICAL M E D I C A L DEVICE D E V I C E functionality f u n c t i o n a l i t y with w i t h software s o f t w a r e is i s normally n o r m a l l y made m a d e during d u r i n g SYSTEM S Y S T E M design. d e s i g n . Some S o m e or o r all a l l of o f the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s are a r e allocated a l l o c a t e d to t o be b e implemented i m p l e m e n t e d in i n software. s o f t w a r e . The T h e granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 48 4 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 software s o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s ACTIVITY A C T I V I T Y consists c o n s i s t s of o f analyzing a n a l y z i n g the t h e requirements r e q u i r e m e n t s allocated a l l o c a t e d to t o software s o f t w a r e by b y the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s PROCESS P R O C E S S and a n d deriving d e r i v i n g a a comprehensive c o m p r e h e n s i v e set s e t of o f software s o f t w a r e requirements r e q u i r e m e n t s that t h a t reflect r e f l e c t the t h e allocated a l l o c a t e d requirements. r e q u i r e m e n t s . To T o ensure e n s u r e the t h e integrity i n t e g r i t y of o f the t h e SYSTEM, S Y S T E M , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d provide p r o v i d e a a mechanism m e c h a n i s m for f o r negotiating n e g o t i a t i n g changes c h a n g e s and a n d clarifications c l a r i f i c a t i o n s to t o the t h e SYSTEM S Y S T E M requirements r e q u i r e m e n t s to t o correct c o r r e c t impracticalities, i m p r a c t i c a l i t i e s , inconsistencies i n c o n s i s t e n c i e s or o r ambiguities a m b i g u i t i e s in i n either e i t h e r the t h e parent p a r e n t SYSTEM S Y S T E M requirements r e q u i r e m e n t s or o r the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . The T h e PROCESS P R O C E S S of o f capture c a p t u r e and a n d analysis a n a l y s i s of o f SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e iterative. i t e r a t i v e . This T h i s standard s t a n d a r d does d o e s not n o t intend i n t e n d to t o require r e q u i r e the t h e PROCESSES P R O C E S S E S to t o be b e rigidly r i g i d l y segregated s e g r e g a t e d into i n t o two t w o layers. l a y e r s . In I n practice, p r a c t i c e , SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E are a r e often o f t e n outlined o u t l i n e d simultaneously s i m u l t a n e o u s l y and a n d the t h e SYSTEM S Y S T E M and a n d software s o f t w a r e requirements r e q u i r e m e n t s are a r e subsequently s u b s e q u e n t l y documented d o c u m e n t e d in i n a a layered l a y e r e d form. f o r m . B.5.3 B . 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o define d e f i n e the t h e major m a j o r structural s t r u c t u r a l components c o m p o n e n t s of o f the t h e software s o f t w a r e and a n d identify i d e n t i f y their t h e i r key k e y responsibilities, r e s p o n s i b i l i t i e s , their t h e i r externally e x t e r n a l l y visible v i s i b l e properties, p r o p e r t i e s , and a n d the t h e relationship r e l a t i o n s h i p among a m o n g them. t h e m . If I f the t h e behaviour b e h a v i o u r of o f a a component c o m p o n e n t can c a n affect a f f e c t other o t h e r components, c o m p o n e n t s , that t h a t behavior b e h a v i o r should s h o u l d be b e described d e s c r i b e d in i n the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . This T h i s description d e s c r i p t i o n is i s especially e s p e c i a l l y important i m p o r t a n t for f o r behaviour b e h a v i o u r that t h a t can c a n affect a f f e c t components c o m p o n e n t s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E that t h a t are a r e outside o u t s i d e the t h e software s o f t w a r e (see ( s e e 5.3.5 5 . 3 . 5 and a n d B.4.3). B . 4 . 3 ) . ARCHITECTURAL A R C H I T E C T U R A L decisions d e c i s i o n s are a r e extremely e x t r e m e l y important i m p o r t a n t for f o r implementing i m p l e m e n t i n g RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . Without W i t h o u t understanding u n d e r s t a n d i n g (and ( a n d documenting) d o c u m e n t i n g ) the t h e behaviour b e h a v i o u r of o f a a component c o m p o n e n t that t h a t can c a n affect a f f e c t other o t h e r components, c o m p o n e n t s , it i t will w i l l be b e nearly n e a r l y impossible i m p o s s i b l e to t o show s h o w that t h a t the t h e SYSTEM S Y S T E M is i s safe. s a f e . A A software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s necessary n e c e s s a r y to t o ensure e n s u r e the t h e correct c o r r e c t implementation i m p l e m e n t a t i o n of o f the t h e software s o f t w a r e requirements. r e q u i r e m e n t s . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E is i s not n o t complete c o m p l e t e unless u n l e s s all a l l software s o f t w a r e requirements r e q u i r e m e n t s can c a n be b e implemented i m p l e m e n t e d by b y the t h e identified i d e n t i f i e d SOFTWARE S O F T W A R E ITEMS. I T E M S . Because B e c a u s e the t h e design d e s i g n and a n d implementation i m p l e m e n t a t i o n of o f the t h e software s o f t w a r e is i s dependent d e p e n d e n t on o n the t h e ARCHITECTURE, A R C H I T E C T U R E , the t h e ARCHITECTURE A R C H I T E C T U R E is i s VERIFIED V E R I F I E D to t o complete c o m p l e t e this t h i s ACTIVITY. A C T I V I T Y . VERIFICATION V E R I F I C A T I O N of o f the t h e ARCHITECTURE A R C H I T E C T U R E is i s generally g e n e r a l l y done d o n e by b y technical t e c h n i c a l EVALUATION. E V A L U A T I O N . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S during d u r i n g the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E ACTIVITY A C T I V I T Y creates c r e a t e s a a basis b a s i s for f o r the t h e subsequent s u b s e q u e n t choice c h o i c e of o f software s o f t w a r e PROCESSES. P R O C E S S E S . The T h e records r e c o r d s of o f classification c l a s s i f i c a t i o n are a r e placed p l a c e d under u n d e r change c h a n g e control c o n t r o l as a s part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . Many M a n y subsequent s u b s e q u e n t events e v e n t s might m i g h t invalidate i n v a l i d a t e the t h e classification. c l a s s i f i c a t i o n . These T h e s e include, i n c l u d e , for f o r example: e x a m p l e : – – changes c h a n g e s of o f SYSTEM S Y S T E M specification, s p e c i f i c a t i o n , software s o f t w a r e specification s p e c i f i c a t i o n or o r ARCHITECTURE; A R C H I T E C T U R E ; – – discovery d i s c o v e r y of o f errors e r r o r s in i n the t h e RISK R I S K ANALYSIS, A N A L Y S I S , especially e s p e c i a l l y unforeseen u n f o r e s e e n HAZARDS; H A Z A R D S ; and a n d – – discovery d i s c o v e r y of o f the t h e infeasibility i n f e a s i b i l i t y of o f a a requirement, r e q u i r e m e n t , especially e s p e c i a l l y a a RISK R I S K CONTROL C O N T R O L measure; m e a s u r e ; Therefore, T h e r e f o r e , during d u r i n g all a l l ACTIVITIES A C T I V I T I E S following f o l l o w i n g the t h e design d e s i g n of o f the t h e software s o f t w a r e ARCHITECTURE, A R C H I T E C T U R E , the t h e classification c l a s s i f i c a t i o n of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M and a n d SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e re-EVALUATED r e - E V A L U A T E D and a n d might m i g h t need n e e d to t o be b e revised. r e v i s e d . This T h i s would w o u l d trigger t r i g g e r rework r e w o r k to t o apply a p p l y additional a d d i t i o n a l PROCESSES P R O C E S S E S to t o a a SOFTWARE S O F T W A R E ITEM I T E M as a s a a result r e s u l t of o f its i t s upgrading u p g r a d i n g to t o a a higher h i g h e r class. c l a s s . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S (Clause ( C l a u s e 8) 8 ) is i s used u s e d to t o ensure e n s u r e that t h a t all a l l necessary n e c e s s a r y rework r e w o r k is i s identified i d e n t i f i e d and a n d completed. c o m p l e t e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5.4 B . 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o refine r e f i n e the t h e SOFTWARE S O F T W A R E ITEMS I T E M S and a n d interfaces i n t e r f a c e s defined d e f i n e d in i n the t h e ARCHITECTURE A R C H I T E C T U R E to t o create c r e a t e SOFTWARE S O F T W A R E UNITS U N I T S and a n d their t h e i r interfaces. i n t e r f a c e s . Although A l t h o u g h SOFTWARE S O F T W A R E UNITS U N I T S are a r e often o f t e n thought t h o u g h t of o f as a s being b e i n g a a single s i n g l e function f u n c t i o n or o r module, m o d u l e , this t h i s view v i e w is i s not n o t always a l w a y s appropriate. a p p r o p r i a t e . This T h i s standard s t a n d a r d has h a s defined d e f i n e d SOFTWARE S O F T W A R E UNIT U N I T to t o be b e a a SOFTWARE S O F T W A R E ITEM I T E M that t h a t is i s not n o t subdivided s u b d i v i d e d into i n t o smaller s m a l l e r items. i t e m s . SOFTWARE S O F T W A R E UNITS U N I T S can c a n be b e tested t e s t e d separately. s e p a r a t e l y . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d define d e f i n e the t h e level l e v e l of o f detail d e t a i l of o f the t h e SOFTWARE S O F T W A R E UNIT. U N I T . Detailed D e t a i l e d design d e s i g n specifies s p e c i f i e s algorithms, a l g o r i t h m s , data d a t a representations, r e p r e s e n t a t i o n s , interfaces i n t e r f a c e s among a m o n g different d i f f e r e n t SOFTWARE S O F T W A R E UNITS, U N I T S , and a n d interfaces i n t e r f a c e s between b e t w e e n SOFTWARE S O F T W A R E UNITS U N I T S and a n d data d a t a structures. s t r u c t u r e s . Detailed D e t a i l e d design d e s i g n must m u s t also a l s o be b e concerned c o n c e r n e d with w i t h the t h e packaging p a c k a g i n g of o f the t h e SOFTWARE S O F T W A R E PRODUCT. P R O D U C T . It I t is i s necessary n e c e s s a r y to t o define d e f i n e the t h e design d e s i g n of o f the t h e SOFTWARE S O F T W A R E UNITS U N I T S and a n d the t h e interfaces i n t e r f a c e s in i n sufficient s u f f i c i e n t detail d e t a i l to t o permit p e r m i t its i t s SAFETY S A F E T Y and a n d effectiveness e f f e c t i v e n e s s to t o be b e objectively o b j e c t i v e l y VERIFIED V E R I F I E D where w h e r e this t h i s can c a n be b e ensured e n s u r e d using u s i n g other o t h e r requirements r e q u i r e m e n t s or o r design d e s i g n documentation. d o c u m e n t a t i o n . It I t should s h o u l d be b e complete c o m p l e t e enough e n o u g h granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 49 4 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 that t h a t the t h e programmer p r o g r a m m e r is i s not n o t required r e q u i r e d to t o make m a k e ad a d hoc h o c design d e s i g n decisions. d e c i s i o n s . Detailed D e t a i l e d design d e s i g n must m u s t also a l s o be b e concerned c o n c e r n e d with w i t h the t h e architecture a r c h i t e c t u r e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . A A SOFTWARE S O F T W A R E ITEM I T E M can c a n be b e decomposed d e c o m p o s e d so s o that t h a t only o n l y a a few f e w of o f the t h e new n e w SOFTWARE S O F T W A R E ITEMS I T E M S implement i m p l e m e n t the t h e SAFETY-related S A F E T Y - r e l a t e d requirement r e q u i r e m e n t of o f the t h e original o r i g i n a l SOFTWARE S O F T W A R E ITEM. I T E M . The T h e remaining r e m a i n i n g SOFTWARE S O F T W A R E ITEMS I T E M S do d o not n o t implement i m p l e m e n t SAFETY-related S A F E T Y - r e l a t e d functions f u n c t i o n s and a n d can c a n be b e reclassified r e c l a s s i f i e d into i n t o a a lower l o w e r software s o f t w a r e safety s a f e t y class. c l a s s . However, H o w e v e r , the t h e decision d e c i s i o n to t o do d o this t h i s is i s in i n itself i t s e l f part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS, P R O C E S S , and a n d is i s documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . Because B e c a u s e implementation i m p l e m e n t a t i o n depends d e p e n d s on o n detailed d e t a i l e d design, d e s i g n , it i t is i s necessary n e c e s s a r y to t o verify v e r i f y the t h e detailed d e t a i l e d design d e s i g n before b e f o r e the t h e ACTIVITY A C T I V I T Y is i s complete. c o m p l e t e . VERIFICATION V E R I F I C A T I O N of o f detailed d e t a i l e d design d e s i g n is i s generally g e n e r a l l y done d o n e by b y a a technical t e c h n i c a l EVALUATION. E V A L U A T I O N . Subclause S u b c l a u s e 5.4.4 5 . 4 . 4 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e outputs o u t p u t s of o f the t h e detailed d e t a i l e d design d e s i g n ACTIVITIES. A C T I V I T I E S . The T h e design d e s i g n specifies s p e c i f i e s how h o w the t h e requirements r e q u i r e m e n t s are a r e to t o be b e implemented. i m p l e m e n t e d . VERIFICATION V E R I F I C A T I O N of o f the t h e design d e s i g n provides p r o v i d e s assurance a s s u r a n c e that t h a t it i t implements i m p l e m e n t s the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E and a n d is i s free f r e e from f r o m contradiction c o n t r a d i c t i o n with w i t h the t h e software s o f t w a r e ARCHITECTURE. A R C H I T E C T U R E . If I f the t h e design d e s i g n contains c o n t a i n s defects, d e f e c t s , the t h e code c o d e will w i l l not n o t implement i m p l e m e n t the t h e requirements r e q u i r e m e n t s correctly. c o r r e c t l y . When W h e n present p r e s e n t in i n the t h e design, d e s i g n , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d verify v e r i f y design d e s i g n characteristics c h a r a c t e r i s t i c s which w h i c h the t h e MANUFACTURER M A N U F A C T U R E R believes b e l i e v e s are a r e important i m p o r t a n t for f o r SAFETY. S A F E T Y . Examples E x a m p l e s of o f these t h e s e characteristics c h a r a c t e r i s t i c s include: i n c l u d e : – – implementation i m p l e m e n t a t i o n of o f the t h e intended i n t e n d e d events, e v e n t s , inputs, i n p u t s , outputs, o u t p u t s , interfaces, i n t e r f a c e s , logic l o g i c flow, f l o w , allocation a l l o c a t i o n of o f CPU, C P U , allocation a l l o c a t i o n of o f memory m e m o r y resources, r e s o u r c e s , error e r r o r and a n d exception e x c e p t i o n definition, d e f i n i t i o n , error e r r o r and a n d exception e x c e p t i o n isolation, i s o l a t i o n , and a n d error e r r o r recovery; r e c o v e r y ; – – definition d e f i n i t i o n of o f the t h e default d e f a u l t state, s t a t e , in i n which w h i c h all a l l faults f a u l t s that t h a t can c a n result r e s u l t in i n a a hazardous h a z a r d o u s situation s i t u a t i o n are a r e addressed, a d d r e s s e d , with w i t h events e v e n t s and a n d transitions; t r a n s i t i o n s ; – – initialization i n i t i a l i z a t i o n of o f variables, v a r i a b l e s , memory m e m o r y management; m a n a g e m e n t ; and a n d – – cold c o l d and a n d warm w a r m resets, r e s e t s , standby, s t a n d b y , and a n d other o t h e r state s t a t e changes c h a n g e s that t h a t can c a n affect a f f e c t the t h e RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . B.5.5 B . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o write w r i t e and a n d verify v e r i f y the t h e code c o d e for f o r the t h e SOFTWARE S O F T W A R E UNITS. U N I T S . The T h e detailed d e t a i l e d design d e s i g n is i s to t o be b e translated t r a n s l a t e d into i n t o source s o u r c e code. c o d e . Coding C o d i n g represents r e p r e s e n t s the t h e point p o i n t where w h e r e decomposition d e c o m p o s i t i o n of o f the t h e specifications s p e c i f i c a t i o n s ends e n d s and a n d composition c o m p o s i t i o n of o f the t h e executable e x e c u t a b l e software s o f t w a r e begins. b e g i n s . To T o consistently c o n s i s t e n t l y achieve a c h i e v e the t h e desirable d e s i r a b l e code c o d e characteristics, c h a r a c t e r i s t i c s , coding c o d i n g standards s t a n d a r d s should s h o u l d be b e used u s e d to t o specify s p e c i f y a a preferred p r e f e r r e d coding c o d i n g style. s t y l e . Examples E x a m p l e s of o f coding c o d i n g standards s t a n d a r d s include i n c l u d e requirements r e q u i r e m e n t s for f o r understandability, u n d e r s t a n d a b i l i t y , language l a n g u a g e usage u s a g e rules r u l e s or o r restrictions, r e s t r i c t i o n s , and a n d complexity c o m p l e x i t y management. m a n a g e m e n t . The T h e code c o d e for f o r each e a c h unit u n i t is i s VERIFIED V E R I F I E D to t o ensure e n s u r e that t h a t it i t functions f u n c t i o n s as a s specified s p e c i f i e d by b y the t h e detailed d e t a i l e d design d e s i g n and a n d that t h a t it i t complies c o m p l i e s with w i t h the t h e specified s p e c i f i e d coding c o d i n g standards. s t a n d a r d s . Subclause S u b c l a u s e 5.5.5 5 . 5 . 5 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e code. c o d e . If I f the t h e code c o d e does d o e s not n o t implement i m p l e m e n t the t h e design d e s i g n correctly, c o r r e c t l y , the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E will w i l l not n o t perform p e r f o r m as a s intended. i n t e n d e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5.6 B . 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o plan p l a n and a n d execute e x e c u t e integration i n t e g r a t i o n of o f SOFTWARE S O F T W A R E UNITS U N I T S into i n t o aggregate a g g r e g a t e SOFTWARE S O F T W A R E ITEMS I T E M S as a s well w e l l as a s integration i n t e g r a t i o n of o f SOFTWARE S O F T W A R E ITEMS I T E M S into i n t o higher h i g h e r aggregated a g g r e g a t e d SOFTWARE S O F T W A R E ITEMS I T E M S and a n d to t o verify v e r i f y that t h a t the t h e resulting r e s u l t i n g SOFTWARE S O F T W A R E ITEMS I T E M S behave b e h a v e as a s intended. i n t e n d e d . The T h e approach a p p r o a c h to t o integration i n t e g r a t i o n can c a n range r a n g e from f r o m non-incremental n o n - i n c r e m e n t a l integration i n t e g r a t i o n to t o any a n y form f o r m of o f incremental i n c r e m e n t a l integration. i n t e g r a t i o n . The T h e properties p r o p e r t i e s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M being b e i n g assembled a s s e m b l e d dictate d i c t a t e the t h e chosen c h o s e n method m e t h o d of o f integration. i n t e g r a t i o n . Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g focuses f o c u s e s on o n the t h e transfer t r a n s f e r of o f data d a t a and a n d control c o n t r o l across a c r o s s a a SOFTWARE S O F T W A R E ITEM’s I T E M ’ s internal i n t e r n a l and a n d external e x t e r n a l interfaces. i n t e r f a c e s . External E x t e r n a l interfaces i n t e r f a c e s are a r e those t h o s e with w i t h other o t h e r software, s o f t w a r e , including i n c l u d i n g operating o p e r a t i n g system s y s t e m software, s o f t w a r e , and a n d MEDICAL M E D I C A L DEVICE D E V I C E hardware. h a r d w a r e . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 50 5 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e rigor r i g o r of o f integration i n t e g r a t i o n testing t e s t i n g and a n d the t h e level l e v e l of o f detail d e t a i l of o f the t h e documentation d o c u m e n t a t i o n associated a s s o c i a t e d with w i t h integration i n t e g r a t i o n testing t e s t i n g should s h o u l d be b e commensurate c o m m e n s u r a t e with w i t h the t h e RISK R I S K associated a s s o c i a t e d with w i t h the t h e device, d e v i c e , the t h e device’s d e v i c e ’ s dependence d e p e n d e n c e on o n software s o f t w a r e for f o r potentially p o t e n t i a l l y hazardous h a z a r d o u s functions, f u n c t i o n s , and a n d the t h e role r o l e of o f specific s p e c i f i c SOFTWARE S O F T W A R E ITEMS I T E M S in i n higher h i g h e r RISK R I S K device d e v i c e functions. f u n c t i o n s . For F o r example, e x a m p l e , although a l t h o u g h all a l l SOFTWARE S O F T W A R E ITEMS I T E M S should s h o u l d be b e tested, t e s t e d , items i t e m s that t h a t have h a v e an a n effect e f f e c t on o n SAFETY S A F E T Y should s h o u l d be b e subject s u b j e c t to t o more m o r e direct, d i r e c t , thorough, t h o r o u g h , and a n d detailed d e t a i l e d tests. t e s t s . As A s applicable, a p p l i c a b l e , integration i n t e g r a t i o n testing t e s t i n g demonstrates d e m o n s t r a t e s program p r o g r a m behaviour b e h a v i o u r at a t the t h e boundaries b o u n d a r i e s of o f its i t s input i n p u t and a n d output o u t p u t domains d o m a i n s and a n d confirms c o n f i r m s program p r o g r a m responses r e s p o n s e s to t o invalid, i n v a l i d , unexpected, u n e x p e c t e d , and a n d special s p e c i a l inputs. i n p u t s . The T h e program’s p r o g r a m ’ s actions a c t i o n s are a r e revealed r e v e a l e d when w h e n given g i v e n combinations c o m b i n a t i o n s of o f inputs i n p u t s or o r unexpected u n e x p e c t e d sequences s e q u e n c e s of o f inputs, i n p u t s , or o r when w h e n defined d e f i n e d timing t i m i n g requirements r e q u i r e m e n t s are a r e violated. v i o l a t e d . The T h e test t e s t requirements r e q u i r e m e n t s in i n the t h e plan p l a n should s h o u l d include, i n c l u d e , as a s appropriate, a p p r o p r i a t e , the t h e types t y p e s of o f white w h i t e box b o x testing t e s t i n g to t o be b e performed p e r f o r m e d as a s part p a r t of o f integration i n t e g r a t i o n testing. t e s t i n g . White W h i t e box b o x testing, t e s t i n g , also a l s o known k n o w n as a s glass g l a s s box, b o x , structural, s t r u c t u r a l , clear c l e a r box b o x and a n d open o p e n box b o x testing, t e s t i n g , is i s a a testing t e s t i n g technique t e c h n i q u e where w h e r e explicit e x p l i c i t knowledge k n o w l e d g e of o f the t h e internal i n t e r n a l workings w o r k i n g s of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M being b e i n g tested t e s t e d are a r e used u s e d to t o select s e l e c t the t h e test t e s t data. d a t a . White W h i t e box b o x testing t e s t i n g uses u s e s specific s p e c i f i c knowledge k n o w l e d g e of o f the t h e SOFTWARE S O F T W A R E ITEM I T E M to t o examine e x a m i n e outputs. o u t p u t s . The T h e test t e s t is i s accurate a c c u r a t e only o n l y if i f the t h e tester t e s t e r knows k n o w s what w h a t the t h e SOFTWARE S O F T W A R E ITEM I T E M is i s supposed s u p p o s e d to t o do. d o . The T h e tester t e s t e r can c a n then t h e n see s e e if i f the t h e SOFTWARE S O F T W A R E ITEM I T E M diverges d i v e r g e s from f r o m its i t s intended i n t e n d e d goal. g o a l . White W h i t e box b o x testing t e s t i n g cannot c a n n o t guarantee g u a r a n t e e that t h a t the t h e complete c o m p l e t e specification s p e c i f i c a t i o n has h a s been b e e n implemented i m p l e m e n t e d since s i n c e it i t is i s focused f o c u s e d on o n testing t e s t i n g the t h e implementation i m p l e m e n t a t i o n of o f the t h e SOFTWARE S O F T W A R E ITEM. I T E M . Black B l a c k box b o x testing, t e s t i n g , also a l s o known k n o w n as a s behavioural, b e h a v i o u r a l , functional, f u n c t i o n a l , opaque-box, o p a q u e - b o x , and a n d closed-box c l o s e d - b o x testing, t e s t i n g , is i s focused f o c u s e d on o n testing t e s t i n g the t h e functional f u n c t i o n a l specification s p e c i f i c a t i o n and a n d it i t cannot c a n n o t guarantee g u a r a n t e e that t h a t all a l l parts p a r t s of o f the t h e implementation i m p l e m e n t a t i o n have h a v e been b e e n tested. t e s t e d . Thus T h u s black b l a c k box b o x testing t e s t i n g is i s testing t e s t i n g against a g a i n s t the t h e specification s p e c i f i c a t i o n and a n d will w i l l discover d i s c o v e r faults f a u l t s of o f omission, o m i s s i o n , indicating i n d i c a t i n g that t h a t part p a r t of o f the t h e specification s p e c i f i c a t i o n has h a s not n o t been b e e n fulfilled. f u l f i l l e d . White W h i t e box b o x testing t e s t i n g is i s testing t e s t i n g against a g a i n s t the t h e implementation i m p l e m e n t a t i o n and a n d will w i l l discover d i s c o v e r faults f a u l t s of o f commission, c o m m i s s i o n , indicating i n d i c a t i n g that t h a t part p a r t of o f the t h e implementation i m p l e m e n t a t i o n is i s faulty. f a u l t y . In I n order o r d e r to t o fully f u l l y test t e s t MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E both b o t h black b l a c k and a n d white w h i t e box b o x testing t e s t i n g might m i g h t be b e required. r e q u i r e d . The T h e plans p l a n s and a n d test t e s t documentation d o c u m e n t a t i o n identified i d e n t i f i e d in i n 5.6 5 . 6 and a n d 5.7 5 . 7 can c a n be b e individual i n d i v i d u a l documents d o c u m e n t s tied t i e d to t o specific s p e c i f i c phases p h a s e s of o f development d e v e l o p m e n t or o r evolutionary e v o l u t i o n a r y prototypes. p r o t o t y p e s . They T h e y also a l s o might m i g h t be b e combined c o m b i n e d so s o a a single s i n g l e document d o c u m e n t or o r set s e t of o f documents d o c u m e n t s covers c o v e r s the t h e requirements r e q u i r e m e n t s of o f multiple m u l t i p l e subsections. s u b s e c t i o n s . All A l l or o r portions p o r t i o n s of o f the t h e documents d o c u m e n t s could c o u l d be b e incorporated i n c o r p o r a t e d into i n t o higher h i g h e r level l e v e l project p r o j e c t documents d o c u m e n t s such s u c h as a s a a software s o f t w a r e or o r project p r o j e c t quality q u a l i t y assurance a s s u r a n c e plan p l a n or o r a a comprehensive c o m p r e h e n s i v e test t e s t plan p l a n that t h a t addresses a d d r e s s e s all a l l aspects a s p e c t s of o f testing t e s t i n g for f o r hardware h a r d w a r e and a n d software. s o f t w a r e . In I n these t h e s e cases, c a s e s , a a cross c r o s s reference r e f e r e n c e should s h o u l d be b e created c r e a t e d that t h a t identifies i d e n t i f i e s how h o w the t h e various v a r i o u s project p r o j e c t documents d o c u m e n t s relate r e l a t e to t o each e a c h of o f the t h e software s o f t w a r e integration i n t e g r a t i o n TASKS. T A S K S . Software S o f t w a r e integration i n t e g r a t i o n testing t e s t i n g can c a n be b e performed p e r f o r m e d in i n a a simulated s i m u l a t e d environment, e n v i r o n m e n t , on o n actual a c t u a l target t a r g e t hardware, h a r d w a r e , or o r on o n the t h e full f u l l MEDICAL M E D I C A L DEVICE. D E V I C E . Subclause S u b c l a u s e 5.6.2 5 . 6 . 2 requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e output o u t p u t of o f the t h e software s o f t w a r e integration i n t e g r a t i o n ACTIVITY. A C T I V I T Y . The T h e output o u t p u t of o f the t h e software s o f t w a r e integration i n t e g r a t i o n ACTIVITY A C T I V I T Y is i s the t h e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS. I T E M S . These T h e s e integrated i n t e g r a t e d SOFTWARE S O F T W A R E ITEMS I T E M S must m u s t function f u n c t i o n properly p r o p e r l y for f o r the t h e entire e n t i r e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E to t o function f u n c t i o n correctly c o r r e c t l y and a n d safely. s a f e l y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.5.7 B . 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o verify v e r i f y the t h e software’s s o f t w a r e ’ s functionality f u n c t i o n a l i t y by b y verifying v e r i f y i n g that t h a t the t h e requirements r e q u i r e m e n t s for f o r the t h e software s o f t w a r e have h a v e been b e e n successfully s u c c e s s f u l l y implemented. i m p l e m e n t e d . SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g demonstrates d e m o n s t r a t e s that t h a t the t h e specified s p e c i f i e d functionality f u n c t i o n a l i t y exists. e x i s t s . This T h i s testing t e s t i n g VERIFIES V E R I F I E S the t h e functionality f u n c t i o n a l i t y and a n d performance p e r f o r m a n c e of o f the t h e program p r o g r a m as a s built b u i l t with w i t h respect r e s p e c t to t o the t h e requirements r e q u i r e m e n t s for f o r the t h e software. s o f t w a r e . SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g focuses f o c u s e s on o n functional f u n c t i o n a l (black ( b l a c k box) b o x ) testing, t e s t i n g , although a l t h o u g h it i t might m i g h t be b e desirable d e s i r a b l e to t o use u s e white w h i t e box b o x (see ( s e e previous p r e v i o u s section) s e c t i o n ) methods m e t h o d s to t o more m o r e efficiently e f f i c i e n t l y accomplish a c c o m p l i s h certain c e r t a i n tests, t e s t s , initiate i n i t i a t e stress s t r e s s conditions c o n d i t i o n s or o r faults, f a u l t s , or o r increase i n c r e a s e code c o d e coverage c o v e r a g e of o f the t h e qualification q u a l i f i c a t i o n tests. t e s t s . The T h e organization o r g a n i z a t i o n of o f testing t e s t i n g by b y types t y p e s and a n d test t e s t stage s t a g e is i s flexible, f l e x i b l e , but b u t coverage c o v e r a g e of o f granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 51 5 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 requirements, r e q u i r e m e n t s , RISK R I S K CONTROL, C O N T R O L , usability, u s a b i l i t y , and a n d test t e s t types t y p e s (e.g., ( e . g . , fault, f a u l t , installation, i n s t a l l a t i o n , stress) s t r e s s ) should s h o u l d be b e demonstrated d e m o n s t r a t e d and a n d documented. d o c u m e n t e d . SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g tests t e s t s the t h e integrated i n t e g r a t e d software s o f t w a r e and a n d can c a n be b e performed p e r f o r m e d in i n a a simulated s i m u l a t e d environment, e n v i r o n m e n t , on o n actual a c t u a l target t a r g e t hardware, h a r d w a r e , or o r on o n the t h e full f u l l MEDICAL M E D I C A L DEVICE. D E V I C E . When W h e n a a change c h a n g e is i s made m a d e to t o a a SOFTWARE S O F T W A R E SYSTEM S Y S T E M (even ( e v e n a a small s m a l l change), c h a n g e ) , the t h e degree d e g r e e of o f REGRESSION R E G R E S S I O N TESTING T E S T I N G (not ( n o t just j u s t the t h e testing t e s t i n g of o f the t h e individual i n d i v i d u a l change) c h a n g e ) should s h o u l d be b e determined d e t e r m i n e d to t o ensure e n s u r e that t h a t no n o unintended u n i n t e n d e d side s i d e effects e f f e c t s have h a v e been b e e n introduced. i n t r o d u c e d . This T h i s REGRESSION R E G R E S S I O N TESTING T E S T I N G (and ( a n d the t h e rationale r a t i o n a l e for f o r not n o t fully f u l l y repeating r e p e a t i n g SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing) t e s t i n g ) should s h o u l d be b e planned p l a n n e d and a n d documented. d o c u m e n t e d . (See ( S e e B.6.3). B . 6 . 3 ) . SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t responsibilities r e s p o n s i b i l i t i e s can c a n be b e dispersed, d i s p e r s e d , occurring o c c u r r i n g at a t different d i f f e r e n t locations l o c a t i o n s and a n d being b e i n g conducted c o n d u c t e d by b y different d i f f e r e n t organizations. o r g a n i z a t i o n s . However, H o w e v e r , regardless r e g a r d l e s s of o f the t h e distribution d i s t r i b u t i o n of o f TASKS, T A S K S , contractual c o n t r a c t u a l relations, r e l a t i o n s , source s o u r c e of o f components, c o m p o n e n t s , or o r development d e v e l o p m e n t environment, e n v i r o n m e n t , the t h e device d e v i c e MANUFACTURER M A N U F A C T U R E R retains r e t a i n s ultimate u l t i m a t e responsibility r e s p o n s i b i l i t y for f o r ensuring e n s u r i n g that t h a t the t h e software s o f t w a r e functions f u n c t i o n s properly p r o p e r l y for f o r its i t s intended i n t e n d e d use. u s e . If I f ANOMALIES A N O M A L I E S uncovered u n c o v e r e d during d u r i n g testing t e s t i n g can c a n be b e repeated, r e p e a t e d , but b u t a a decision d e c i s i o n has h a s been b e e n made m a d e not n o t to t o fix f i x them, t h e m , then t h e n these t h e s e ANOMALIES A N O M A L I E S need n e e d to t o be b e EVALUATED E V A L U A T E D in i n relation r e l a t i o n to t o the t h e RISK R I S K analysis a n a l y s i s to t o verify v e r i f y that t h a t they t h e y do d o not n o t affect a f f e c t the t h e SAFETY S A F E T Y of o f the t h e device. d e v i c e . The T h e root r o o t cause c a u s e and a n d symptoms s y m p t o m s of o f the t h e ANOMALIES A N O M A L I E S should s h o u l d be b e understood, u n d e r s t o o d , and a n d the t h e rationale r a t i o n a l e for f o r not n o t fixing f i x i n g them t h e m should s h o u l d be b e documented. d o c u m e n t e d . Subclause S u b c l a u s e 5.7.4 5 . 7 . 4 requires r e q u i r e s the t h e results r e s u l t s of o f the t h e SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g be b e EVALUATED E V A L U A T E D to t o ensure e n s u r e that t h a t the t h e expected e x p e c t e d results r e s u l t s were w e r e obtained. o b t a i n e d . B.5.8 B . 5 . 8 Software S o f t w a r e release r e l e a s e This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o document d o c u m e n t the t h e VERSION V E R S I O N of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E being b e i n g released, r e l e a s e d , specify s p e c i f y how h o w it i t was w a s created, c r e a t e d , and a n d follow f o l l o w appropriate a p p r o p r i a t e procedures p r o c e d u r e s for f o r release r e l e a s e of o f the t h e software. s o f t w a r e . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d be b e able a b l e to t o show s h o w that t h a t the t h e software s o f t w a r e that t h a t was w a s developed d e v e l o p e d using u s i n g the t h e development d e v e l o p m e n t PROCESS P R O C E S S is i s the t h e software s o f t w a r e that t h a t is i s being b e i n g released. r e l e a s e d . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d also a l s o be b e able a b l e to t o retrieve r e t r i e v e the t h e software s o f t w a r e and a n d the t h e tools t o o l s used u s e d for f o r its i t s generation g e n e r a t i o n in i n case c a s e it i t is i s needed n e e d e d in i n the t h e future f u t u r e and a n d should s h o u l d store, s t o r e , package, p a c k a g e , and a n d deliver d e l i v e r the t h e software s o f t w a r e in i n a a manner m a n n e r that t h a t minimizes m i n i m i z e s the t h e software s o f t w a r e from f r o m being b e i n g damaged d a m a g e d or o r misused. m i s u s e d . Defined D e f i n e d procedures p r o c e d u r e s should s h o u l d be b e established e s t a b l i s h e d to t o ensure e n s u r e that t h a t these t h e s e TASKS T A S K S are a r e performed p e r f o r m e d appropriately a p p r o p r i a t e l y and a n d with w i t h consistent c o n s i s t e n t results. r e s u l t s . B.6 B . 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S B.6.1 B . 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S differs d i f f e r s from f r o m the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S in i n two t w o ways: w a y s : – – The T h e MANUFACTURER M A N U F A C T U R E R is i s permitted p e r m i t t e d to t o use u s e a a smaller s m a l l e r PROCESS P R O C E S S than t h a n the t h e full f u l l software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S to t o implement i m p l e m e n t rapid r a p i d changes c h a n g e s in i n response r e s p o n s e to t o urgent u r g e n t problems. p r o b l e m s . – – In I n responding r e s p o n d i n g to t o software s o f t w a r e PROBLEMS P R O B L E M S REPORTS R E P O R T S relating r e l a t i n g to t o released r e l e a s e d product, p r o d u c t , the t h e MANUFACTURER M A N U F A C T U R E R not n o t only o n l y addresses a d d r e s s e s the t h e problem p r o b l e m but b u t also a l s o satisfies s a t i s f i e s local l o c a l regulations r e g u l a t i o n s (typically ( t y p i c a l l y by b y running r u n n i n g a a pro-active p r o - a c t i v e surveillance s u r v e i l l a n c e scheme s c h e m e for f o r collecting c o l l e c t i n g problem p r o b l e m data d a t a from f r o m the t h e field f i e l d and a n d communicating c o m m u n i c a t i n g with w i t h users u s e r s and a n d regulators r e g u l a t o r s about a b o u t the t h e problem). p r o b l e m ) . Subclause S u b c l a u s e 6.1 6 . 1 requires r e q u i r e s these t h e s e PROCESSES P R O C E S S E S to t o be b e established e s t a b l i s h e d in i n a a maintenance m a i n t e n a n c e plan. p l a n . This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o create c r e a t e or o r identify i d e n t i f y procedures p r o c e d u r e s for f o r implementing i m p l e m e n t i n g maintenance m a i n t e n a n c e ACTIVITIES A C T I V I T I E S and a n d TASKS. T A S K S . To T o implement i m p l e m e n t corrective c o r r e c t i v e actions, a c t i o n s , control c o n t r o l changes c h a n g e s during d u r i n g maintenance, m a i n t e n a n c e , and a n d manage m a n a g e release r e l e a s e of o f revised r e v i s e d software, s o f t w a r e , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d document d o c u m e n t and a n d resolve r e s o l v e reported r e p o r t e d problems p r o b l e m s and a n d requests r e q u e s t s from f r o m users, u s e r s , as a s well w e l l as a s manage m a n a g e modifications m o d i f i c a t i o n s to t o granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 52 5 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . This T h i s PROCESS P R O C E S S is i s activated a c t i v a t e d when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E undergoes u n d e r g o e s modifications m o d i f i c a t i o n s to t o code c o d e and a n d associated a s s o c i a t e d documentation d o c u m e n t a t i o n because b e c a u s e of o f either e i t h e r a a problem p r o b l e m or o r the t h e need n e e d for f o r improvement i m p r o v e m e n t or o r adaptation. a d a p t a t i o n . The T h e objective o b j e c t i v e is i s to t o modify m o d i f y released r e l e a s e d MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E while w h i l e preserving p r e s e r v i n g its i t s integrity. i n t e g r i t y . This T h i s PROCESS P R O C E S S includes i n c l u d e s migration m i g r a t i o n of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E to t o environments e n v i r o n m e n t s or o r platforms p l a t f o r m s for f o r which w h i c h it i t was w a s not n o t originally o r i g i n a l l y released. r e l e a s e d . The T h e ACTIVITIES A C T I V I T I E S provided p r o v i d e d in i n this t h i s clause c l a u s e are a r e specific s p e c i f i c to t o the t h e maintenance m a i n t e n a n c e PROCESS; P R O C E S S ; however, h o w e v e r , the t h e maintenance m a i n t e n a n c e PROCESS P R O C E S S might m i g h t use u s e other o t h e r PROCESSES P R O C E S S E S in i n this t h i s standard. s t a n d a r d . The T h e MANUFACTURER M A N U F A C T U R E R needs n e e d s to t o plan p l a n how h o w the t h e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S of o f the t h e maintenance m a i n t e n a n c e PROCESS P R O C E S S will w i l l be b e performed. p e r f o r m e d . B.6.2 B . 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o analyze a n a l y z e feedback f e e d b a c k for f o r its i t s effect; e f f e c t ; verify v e r i f y reported r e p o r t e d problems; p r o b l e m s ; and a n d consider, c o n s i d e r , select, s e l e c t , and a n d obtain o b t a i n approval a p p r o v a l for f o r implementing i m p l e m e n t i n g a a modification m o d i f i c a t i o n option. o p t i o n . Problems P r o b l e m s and a n d other o t h e r requests r e q u e s t s for f o r changes c h a n g e s can c a n affect a f f e c t the t h e performance, p e r f o r m a n c e , SAFETY, S A F E T Y , or o r regulatory r e g u l a t o r y clearance c l e a r a n c e of o f a a MEDICAL M E D I C A L DEVICE. D E V I C E . An A n analysis a n a l y s i s is i s necessary n e c e s s a r y to t o determine d e t e r m i n e whether w h e t h e r any a n y effects e f f e c t s exist e x i s t because b e c a u s e of o f a a PROBLEM P R O B L E M REPORT R E P O R T or o r whether w h e t h e r any a n y effects e f f e c t s will w i l l result r e s u l t from f r o m a a modification m o d i f i c a t i o n to t o correct c o r r e c t a a problem p r o b l e m or o r implement i m p l e m e n t a a request. r e q u e s t . It I t is i s especially e s p e c i a l l y important i m p o r t a n t to t o verify v e r i f y through t h r o u g h trace t r a c e or o r regression r e g r e s s i o n analysis a n a l y s i s that t h a t the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s built b u i l t into i n t o the t h e device d e v i c e are a r e not n o t adversely a d v e r s e l y changed c h a n g e d or o r modified m o d i f i e d by b y the t h e software s o f t w a r e change c h a n g e that t h a t is i s being b e i n g implemented i m p l e m e n t e d as a s part p a r t of o f the t h e software s o f t w a r e maintenance m a i n t e n a n c e ACTIVITY. A C T I V I T Y . It I t is i s also a l s o important i m p o r t a n t to t o verify v e r i f y that t h a t the t h e modified m o d i f i e d software s o f t w a r e does d o e s not n o t cause c a u s e a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N or o r mitigate m i t i g a t e a a RISK R I S K in i n software s o f t w a r e that t h a t previously p r e v i o u s l y did d i d not n o t cause c a u s e a a HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N or o r mitigate m i t i g a t e RISKS. R I S K S . The T h e software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n of o f a a SOFTWARE S O F T W A R E ITEM I T E M might m i g h t have h a v e changed c h a n g e d if i f the t h e software s o f t w a r e modification m o d i f i c a t i o n now n o w can c a n cause c a u s e a a HAZARD H A Z A R D or o r mitigate m i t i g a t e a a RISK. R I S K . It I t is i s important i m p o r t a n t to t o distinguish d i s t i n g u i s h between b e t w e e n software s o f t w a r e maintenance m a i n t e n a n c e (Clause ( C l a u s e 6) 6 ) and a n d software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n (Clause ( C l a u s e 9). 9 ) . The T h e focus f o c u s of o f the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S is i s an a n adequate a d e q u a t e response r e s p o n s e to t o feedback f e e d b a c k arising a r i s i n g after a f t e r release r e l e a s e of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . As A s part p a r t of o f a a MEDICAL M E D I C A L DEVICE, D E V I C E , the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S needs n e e d s to t o ensure e n s u r e that: t h a t : – – SAFETY-related S A F E T Y - r e l a t e d PROBLEM P R O B L E M REPORTS R E P O R T S are a r e addressed a d d r e s s e d and a n d reported r e p o r t e d to t o appropriate a p p r o p r i a t e regulatory r e g u l a t o r y authorities a u t h o r i t i e s and a n d affected a f f e c t e d users; u s e r s ; – – MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s re-validated r e - v a l i d a t e d and a n d re-released r e - r e l e a s e d after a f t e r modification m o d i f i c a t i o n with w i t h formal f o r m a l controls c o n t r o l s that t h a t ensure e n s u r e the t h e rectification r e c t i f i c a t i o n of o f the t h e problem p r o b l e m and a n d the t h e avoidance a v o i d a n c e of o f further f u r t h e r problems; p r o b l e m s ; – – the t h e MANUFACTURER M A N U F A C T U R E R considers c o n s i d e r s what w h a t other o t h e r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E might m i g h t be b e affected a f f e c t e d and a n d takes t a k e s appropriate a p p r o p r i a t e action. a c t i o n . The T h e focus f o c u s of o f software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n is i s the t h e operation o p e r a t i o n of o f a a comprehensive c o m p r e h e n s i v e control c o n t r o l system s y s t e m that: t h a t : � analyses a n a l y s e s PROBLEM P R O B L E M REPORTS R E P O R T S and a n d identifies i d e n t i f i e s all a l l the t h e implications i m p l i c a t i o n s of o f the t h e problem; p r o b l e m ; decides d e c i d e s on o n a a number n u m b e r of o f changes c h a n g e s and a n d identifies i d e n t i f i e s all a l l their t h e i r side-effects; s i d e - e f f e c t s ; � implements i m p l e m e n t s the t h e changes c h a n g e s while w h i l e maintaining m a i n t a i n i n g the t h e consistency c o n s i s t e n c y of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S including i n c l u d i n g the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE; F I L E ; � VERIFIES V E R I F I E S the t h e implementation i m p l e m e n t a t i o n of o f the t h e changes. c h a n g e s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S uses u s e s the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . The T h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S handles h a n d l e s the t h e high-level h i g h - l e v e l decisions d e c i s i o n s about a b o u t the t h e PROBLEM P R O B L E M REPORT R E P O R T (whether ( w h e t h e r a a problem p r o b l e m exists, e x i s t s , whether w h e t h e r it i t has h a s a a significant s i g n i f i c a n t effect e f f e c t on o n SAFETY, S A F E T Y , what w h a t changes c h a n g e s are a r e needed n e e d e d and a n d when w h e n to t o implement i m p l e m e n t them), t h e m ) , and a n d uses u s e s the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S to t o analyse a n a l y s e the t h e PROBLEM P R O B L E M REPORT R E P O R T to t o discover d i s c o v e r all a l l the t h e implications i m p l i c a t i o n s and a n d to t o generate g e n e r a t e possible p o s s i b l e CHANGE C H A N G E REQUESTS R E Q U E S T S which w h i c h identify i d e n t i f y all a l l the t h e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S that t h a t need n e e d to t o be b e changed c h a n g e d and a n d all a l l the t h e VERIFICATION V E R I F I C A T I O N steps s t e p s that t h a t are a r e necessary. n e c e s s a r y . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 53 5 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 B.6.3 B . 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R use u s e an a n established e s t a b l i s h e d PROCESS P R O C E S S to t o make m a k e the t h e modification. m o d i f i c a t i o n . If I f a a maintenance m a i n t e n a n c e PROCESS P R O C E S S has h a s not n o t been b e e n defined, d e f i n e d , the t h e appropriate a p p r o p r i a t e development d e v e l o p m e n t PROCESS P R O C E S S TASKS T A S K S can c a n be b e used u s e d to t o make m a k e the t h e modification. m o d i f i c a t i o n . The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d also a l s o ensure e n s u r e that t h a t the t h e modification m o d i f i c a t i o n does d o e s not n o t cause c a u s e a a negative n e g a t i v e effect e f f e c t on o n other o t h e r parts p a r t s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Unless U n l e s s the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s treated t r e a t e d as a s a a new n e w development, d e v e l o p m e n t , analysis a n a l y s i s of o f the t h e effect e f f e c t of o f a a modification m o d i f i c a t i o n on o n the t h e entire e n t i r e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s necessary. n e c e s s a r y . Regression R e g r e s s i o n analysis a n a l y s i s and a n d testing t e s t i n g are a r e employed e m p l o y e d to t o provide p r o v i d e assurance a s s u r a n c e that t h a t a a change c h a n g e has h a s not n o t created c r e a t e d problems p r o b l e m s elsewhere e l s e w h e r e in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Regression R e g r e s s i o n analysis a n a l y s i s is i s the t h e determination d e t e r m i n a t i o n of o f the t h e impact i m p a c t of o f a a change c h a n g e based b a s e d on o n review r e v i e w of o f the t h e relevant r e l e v a n t documentation d o c u m e n t a t i o n (e.g., ( e . g . , software s o f t w a r e requirements r e q u i r e m e n t s specification, s p e c i f i c a t i o n , software s o f t w a r e design d e s i g n specification, s p e c i f i c a t i o n , source s o u r c e code, c o d e , test t e s t plans, p l a n s , test t e s t cases, c a s e s , test t e s t scripts, s c r i p t s , etc.) e t c . ) in i n order o r d e r to t o identify i d e n t i f y the t h e necessary n e c e s s a r y regression r e g r e s s i o n tests t e s t s to t o be b e run. r u n . Regression R e g r e s s i o n testing t e s t i n g is i s the t h e rerunning r e r u n n i n g of o f test t e s t cases c a s e s that t h a t a a program p r o g r a m has h a s previously p r e v i o u s l y executed e x e c u t e d correctly c o r r e c t l y and a n d comparing c o m p a r i n g the t h e current c u r r e n t result r e s u l t to t o the t h e previous p r e v i o u s result r e s u l t in i n order o r d e r to t o detect d e t e c t unintended u n i n t e n d e d effects e f f e c t s of o f a a software s o f t w a r e change. c h a n g e . A A rationale r a t i o n a l e must m u s t be b e made m a d e that t h a t justifies j u s t i f i e s the t h e amount a m o u n t of o f REGRESSION R E G R E S S I O N TESTING T E S T I N G that t h a t will w i l l be b e performed p e r f o r m e d to t o ensure e n s u r e that t h a t the t h e portions p o r t i o n s of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E not n o t being b e i n g modified m o d i f i e d still s t i l l perform p e r f o r m as a s they t h e y did d i d before b e f o r e the t h e modification m o d i f i c a t i o n was w a s made. m a d e . B.7 B . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T is i s a a part p a r t of o f overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T and a n d cannot c a n n o t be b e adequately a d e q u a t e l y addressed a d d r e s s e d in i n isolation. i s o l a t i o n . This T h i s standard s t a n d a r d requires r e q u i r e s the t h e use u s e of o f a a RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S that t h a t is i s compliant c o m p l i a n t with w i t h ISO I S O 14971. 1 4 9 7 1 . RISK R I S K MANAGEMENT M A N A G E M E N T as a s defined d e f i n e d in i n ISO I S O 14971 1 4 9 7 1 deals d e a l s specifically s p e c i f i c a l l y with w i t h a a framework f r a m e w o r k for f o r effective e f f e c t i v e management m a n a g e m e n t of o f the t h e RISKS R I S K S associated a s s o c i a t e d with w i t h the t h e use u s e of o f MEDICAL M E D I C A L DEVICES. D E V I C E S . One O n e portion p o r t i o n of o f ISO I S O 14971 1 4 9 7 1 pertains p e r t a i n s to t o control c o n t r o l of o f identified i d e n t i f i e d RISKS R I S K S associated a s s o c i a t e d with w i t h each e a c h HAZARD H A Z A R D identified i d e n t i f i e d during d u r i n g the t h e RISK R I S K ANALYSIS. A N A L Y S I S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d is i s intended i n t e n d e d to t o provide p r o v i d e additional a d d i t i o n a l requirements r e q u i r e m e n t s for f o r RISK R I S K CONTROL C O N T R O L for f o r software, s o f t w a r e , including i n c l u d i n g software s o f t w a r e that t h a t has h a s been b e e n identified i d e n t i f i e d during d u r i n g the t h e RISK R I S K ANALYSIS A N A L Y S I S as a s potentially p o t e n t i a l l y contributing c o n t r i b u t i n g to t o a a hazardous h a z a r d o u s situation, s i t u a t i o n , or o r software s o f t w a r e that t h a t is i s used u s e d to t o control c o n t r o l MEDICAL M E D I C A L DEVICE D E V I C E RISKS. R I S K S . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S is i s included i n c l u d e d in i n this t h i s standard s t a n d a r d for f o r two t w o reasons. r e a s o n s . the t h e intended i n t e n d e d audience a u d i e n c e of o f this t h i s standard s t a n d a r d needs n e e d s to t o understand u n d e r s t a n d minimum m i n i m u m requirements r e q u i r e m e n t s for f o r RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n their t h e i r area a r e a of o f responsibility—software; r e s p o n s i b i l i t y — s o f t w a r e ; the t h e general g e n e r a l RISK R I S K MANAGEMENT M A N A G E M E N T standard, s t a n d a r d , ISO I S O 14971, 1 4 9 7 1 , provided p r o v i d e d as a s a a normative n o r m a t i v e reference r e f e r e n c e in i n this t h i s standard, s t a n d a r d , does d o e s not n o t specifically s p e c i f i c a l l y address a d d r e s s the t h e RISK R I S K CONTROL C O N T R O L of o f software s o f t w a r e and a n d the t h e placement p l a c e m e n t of o f RISK R I S K CONTROL C O N T R O L in i n the t h e software s o f t w a r e development d e v e l o p m e n t life l i f e cycle. c y c l e . Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T is i s a a part p a r t of o f overall o v e r a l l MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT. M A N A G E M E N T . Plans, P l a n s , procedures, p r o c e d u r e s , and a n d documentation d o c u m e n t a t i o n required r e q u i r e d for f o r the t h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S can c a n be b e a a series s e r i e s of o f separate s e p a r a t e documents d o c u m e n t s or o r a a single s i n g l e document, d o c u m e n t , or o r they t h e y can c a n be b e integrated i n t e g r a t e d with w i t h the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S and a n d documentation d o c u m e n t a t i o n as a s long l o n g as a s all a l l requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d are a r e met. m e t . B.7.1 B . 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . It I t is i s expected e x p e c t e d that t h a t the t h e device d e v i c e HAZARD H A Z A R D analysis a n a l y s i s will w i l l identify i d e n t i f y hazardous h a z a r d o u s situations s i t u a t i o n s and a n d corresponding c o r r e s p o n d i n g RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o reduce r e d u c e the t h e probability p r o b a b i l i t y and/or a n d / o r severity s e v e r i t y of o f those t h o s e hazardous h a z a r d o u s situations s i t u a t i o n s to t o an a n acceptable a c c e p t a b l e level. l e v e l . It I t is i s also a l s o expected e x p e c t e d that t h a t the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s will w i l l be b e assigned a s s i g n e d to t o software s o f t w a r e functions f u n c t i o n s that t h a t are a r e expected e x p e c t e d to t o implement i m p l e m e n t those t h o s e RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 54 5 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 However, H o w e v e r , it i t is i s not n o t expected e x p e c t e d that t h a t all a l l device d e v i c e hazardous h a z a r d o u s situations s i t u a t i o n s can c a n be b e identified i d e n t i f i e d until u n t i l the t h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E has h a s been b e e n produced. p r o d u c e d . At A t that t h a t time t i m e it i t is i s known k n o w n how h o w software s o f t w a r e functions f u n c t i o n s will w i l l be b e implemented i m p l e m e n t e d in i n software s o f t w a r e components, c o m p o n e n t s , and a n d the t h e practicality p r a c t i c a l i t y of o f the t h e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s assigned a s s i g n e d to t o software s o f t w a r e functions f u n c t i o n s can c a n be b e EVALUATED. E V A L U A T E D . At A t that t h a t time t i m e the t h e device d e v i c e HAZARD H A Z A R D analysis a n a l y s i s should s h o u l d be b e revised r e v i s e d to t o include: i n c l u d e : revised r e v i s e d hazardous h a z a r d o u s situations; s i t u a t i o n s ; � revised r e v i s e d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s and a n d software s o f t w a r e requirements; r e q u i r e m e n t s ; new n e w hazardous h a z a r d o u s situations s i t u a t i o n s arising a r i s i n g from f r o m software, s o f t w a r e , for f o r example e x a m p l e hazardous h a z a r d o u s situations s i t u a t i o n s related r e l a t e d to t o human h u m a n factors. f a c t o r s . The T h e software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E should s h o u l d include i n c l u d e credible c r e d i b l e strategies s t r a t e g i e s for f o r segregating s e g r e g a t i n g software s o f t w a r e components c o m p o n e n t s so s o that t h a t they t h e y do d o not n o t interact i n t e r a c t in i n unsafe u n s a f e ways. w a y s . B.8 B . 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S is i s a a PROCESS P R O C E S S of o f applying a p p l y i n g administrative a d m i n i s t r a t i v e and a n d technical t e c h n i c a l procedures p r o c e d u r e s throughout t h r o u g h o u t the t h e software s o f t w a r e life l i f e cycle c y c l e to t o identify i d e n t i f y and a n d define d e f i n e SOFTWARE S O F T W A R E ITEMS, I T E M S , including i n c l u d i n g documentation, d o c u m e n t a t i o n , in i n a a SYSTEM; S Y S T E M ; control c o n t r o l modifications m o d i f i c a t i o n s and a n d releases r e l e a s e s of o f the t h e items; i t e m s ; and a n d document d o c u m e n t and a n d report r e p o r t the t h e status s t a t u s of o f the t h e items i t e m s and a n d CHANGE C H A N G E REQUESTS. R E Q U E S T S . Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t is i s necessary n e c e s s a r y to t o recreate r e c r e a t e a a SOFTWARE S O F T W A R E ITEM, I T E M , to t o identify i d e n t i f y its i t s constituent c o n s t i t u e n t parts, p a r t s , and a n d to t o provide p r o v i d e a a history h i s t o r y of o f the t h e changes c h a n g e s that t h a t have h a v e been b e e n made m a d e to t o it. i t . B.8.1 B . 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o uniquely u n i q u e l y identify i d e n t i f y software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d their t h e i r VERSIONS. V E R S I O N S . This T h i s identification i d e n t i f i c a t i o n is i s necessary n e c e s s a r y to t o identify i d e n t i f y the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d the t h e VERSIONS V E R S I O N S that t h a t are a r e included i n c l u d e d in i n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . B.8.2 B . 8 . 2 Change C h a n g e control c o n t r o l This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o control c o n t r o l changes c h a n g e s of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d to t o document d o c u m e n t information i n f o r m a t i o n identifying i d e n t i f y i n g CHANGE C H A N G E REQUESTS R E Q U E S T S and a n d providing p r o v i d i n g documentation d o c u m e n t a t i o n about a b o u t their t h e i r disposition. d i s p o s i t i o n . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t unauthorized u n a u t h o r i z e d or o r unintended u n i n t e n d e d changes c h a n g e s are a r e not n o t made m a d e to t o the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S and a n d to t o ensure e n s u r e that t h a t approved a p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S are a r e implemented i m p l e m e n t e d fully f u l l y and a n d verified. v e r i f i e d . CHANGE C H A N G E REQUESTS R E Q U E S T S can c a n be b e approved a p p r o v e d by b y a a change c h a n g e control c o n t r o l board b o a r d or o r by b y a a manager m a n a g e r or o r technical t e c h n i c a l lead l e a d according a c c o r d i n g to t o the t h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t plan. p l a n . Approved A p p r o v e d CHANGE C H A N G E REQUESTS R E Q U E S T S are a r e made m a d e traceable t r a c e a b l e to t o the t h e actual a c t u a l modification m o d i f i c a t i o n and a n d VERIFICATION V E R I F I C A T I O N of o f the t h e software. s o f t w a r e . The T h e requirement r e q u i r e m e n t is i s that t h a t each e a c h actual a c t u a l change c h a n g e be b e linked l i n k e d to t o a a CHANGE C H A N G E REQUEST R E Q U E S T and a n d that t h a t documentation d o c u m e n t a t i o n exists e x i s t s to t o show s h o w that t h a t the t h e CHANGE C H A N G E REQUEST R E Q U E S T was w a s approved. a p p r o v e d . The T h e documentation d o c u m e n t a t i o n might m i g h t be b e change c h a n g e control c o n t r o l board b o a r d minutes, m i n u t e s , an a n approval a p p r o v a l signature, s i g n a t u r e , or o r a a record r e c o r d in i n a a database. d a t a b a s e . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . B.8.3 B . 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s the t h e MANUFACTURER M A N U F A C T U R E R to t o maintain m a i n t a i n records r e c o r d s of o f the t h e history h i s t o r y of o f the t h e software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS. I T E M S . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o determine d e t e r m i n e when w h e n and a n d why w h y changes c h a n g e s were w e r e made. m a d e . Access A c c e s s to t o this t h i s information i n f o r m a t i o n is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t software s o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S contain c o n t a i n only o n l y authorized a u t h o r i z e d modifications. m o d i f i c a t i o n s . B.9 B . 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S The T h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S is i s a a PROCESS P R O C E S S for f o r analyzing a n a l y z i n g and a n d resolving r e s o l v i n g the t h e problems p r o b l e m s (including ( i n c l u d i n g non-conformances), n o n - c o n f o r m a n c e s ) , whatever w h a t e v e r their t h e i r nature n a t u r e or o r source, s o u r c e , including i n c l u d i n g those t h o s e discovered d i s c o v e r e d during d u r i n g the t h e execution e x e c u t i o n of o f development, d e v e l o p m e n t , maintenance, m a i n t e n a n c e , or o r other o t h e r PROCESSES. P R O C E S S E S . The T h e objective o b j e c t i v e is i s to t o provide p r o v i d e a a timely, t i m e l y , responsible, r e s p o n s i b l e , and a n d documented d o c u m e n t e d means m e a n s to t o ensure e n s u r e that t h a t discovered d i s c o v e r e d problems p r o b l e m s are a r e analyzed a n a l y z e d and a n d resolved r e s o l v e d and a n d that t h a t trends t r e n d s are a r e recognized. r e c o g n i z e d . This T h i s PROCESS P R O C E S S is i s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 55 5 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 sometimes s o m e t i m e s called c a l l e d “defect “ d e f e c t tracking” t r a c k i n g ” in i n software s o f t w a r e engineering e n g i n e e r i n g literature. l i t e r a t u r e . It I t is i s called c a l l e d “problem “ p r o b l e m resolution” r e s o l u t i o n ” in i n ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] and a n d IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 [2], [ 2 ] , Amendment A m e n d m e n t 1. 1 . We W e have h a v e chosen c h o s e n to t o call c a l l it i t “software “ s o f t w a r e problem p r o b l e m resolution” r e s o l u t i o n ” in i n this t h i s standard. s t a n d a r d . This T h i s ACTIVITY A C T I V I T Y requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R use u s e the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S when w h e n a a problem p r o b l e m or o r non-conformance n o n - c o n f o r m a n c e is i s identified. i d e n t i f i e d . This T h i s ACTIVITY A C T I V I T Y is i s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t discovered d i s c o v e r e d problems p r o b l e m s are a r e analyzed a n a l y z e d and a n d EVALUATED E V A L U A T E D for f o r possible p o s s i b l e relevance r e l e v a n c e to t o SAFETY S A F E T Y (as ( a s specified s p e c i f i e d in i n ISO I S O 14971). 1 4 9 7 1 ) . Software S o f t w a r e development d e v e l o p m e n t plan(s) p l a n ( s ) or o r procedures, p r o c e d u r e s , as a s required r e q u i r e d in i n 5.1, 5 . 1 , are a r e to t o address a d d r e s s how h o w problems p r o b l e m s or o r non-conformances n o n - c o n f o r m a n c e s will w i l l be b e handled. h a n d l e d . This T h i s includes i n c l u d e s specifying s p e c i f y i n g at a t each e a c h stage s t a g e of o f the t h e life l i f e cycle c y c l e the t h e aspects a s p e c t s of o f the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S that t h a t will w i l l be b e formal f o r m a l and a n d documented d o c u m e n t e d as a s well w e l l as a s when w h e n problems p r o b l e m s and a n d nonconformities n o n c o n f o r m i t i e s are a r e to t o be b e entered e n t e r e d into i n t o the t h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 56 5 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x C C (informative) ( i n f o r m a t i v e ) Relationship R e l a t i o n s h i p to t o other o t h e r standards s t a n d a r d s C.1 C . 1 General G e n e r a l This T h i s standard s t a n d a r d applies a p p l i e s to t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e of o f MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . The T h e software s o f t w a r e is i s considered c o n s i d e r e d a a subsystem s u b s y s t e m of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E or o r is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE. D E V I C E . This T h i s standard s t a n d a r d is i s to t o be b e used u s e d together t o g e t h e r with w i t h other o t h e r appropriate a p p r o p r i a t e standards s t a n d a r d s when w h e n developing d e v e l o p i n g a a MEDICAL M E D I C A L DEVICE. D E V I C E . MEDICAL M E D I C A L DEVICE D E V I C E management m a n a g e m e n t standards s t a n d a r d s such s u c h as a s ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] (see ( s e e C.2 C . 2 and a n d Annex A n n e x D) D ) and a n d ISO I S O 14971 1 4 9 7 1 (see ( s e e Annex A n n e x C.3) C . 3 ) provide p r o v i d e a a management m a n a g e m e n t environment e n v i r o n m e n t that t h a t lays l a y s a a foundation f o u n d a t i o n for f o r an a n organization o r g a n i z a t i o n to t o develop d e v e l o p products. p r o d u c t s . Safety S a f e t y standards s t a n d a r d s such s u c h as a s IEC I E C 60601-1 6 0 6 0 1 - 1 [1] [ 1 ] (see ( s e e Annex A n n e x C.4) C . 4 ) and a n d IEC I E C 61010-1 6 1 0 1 0 - 1 [5] [ 5 ] (see ( s e e Annex A n n e x C.5) C . 5 ) give g i v e specific s p e c i f i c direction d i r e c t i o n for f o r creating c r e a t i n g safe s a f e MEDICAL M E D I C A L DEVICES. D E V I C E S . When W h e n software s o f t w a r e is i s a a part p a r t of o f these t h e s e MEDICAL M E D I C A L DEVICES, D E V I C E S , IEC I E C 62304 6 2 3 0 4 provides p r o v i d e s more m o r e detailed d e t a i l e d direction d i r e c t i o n on o n what w h a t is i s required r e q u i r e d to t o develop d e v e l o p and a n d maintain m a i n t a i n safe s a f e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Many M a n y other o t h e r standards s t a n d a r d s such s u c h as a s ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9] [ 9 ] (see ( s e e Annex A n n e x C.6), C . 6 ) , IEC I E C 61508-3 6 1 5 0 8 - 3 [4] [ 4 ] (see ( s e e Annex A n n e x C.7) C . 7 ) and a n d ISO/IEC I S O / I E C 90003 9 0 0 0 3 [15] [ 1 5 ] can c a n be b e looked l o o k e d to t o as a s a a source s o u r c e of o f methods, m e t h o d s , tools t o o l s and a n d techniques t e c h n i q u e s that t h a t can c a n be b e used u s e d to t o implement i m p l e m e n t the t h e requirements r e q u i r e m e n t s in i n IEC I E C 62304. 6 2 3 0 4 . Figure F i g u r e C.1 C . 1 shows s h o w s the t h e relationship r e l a t i o n s h i p of o f these t h e s e standards. s t a n d a r d s . Where W h e r e clauses c l a u s e s or o r requirements r e q u i r e m e n t s from f r o m other o t h e r standards s t a n d a r d s are a r e quoted, q u o t e d , defined d e f i n e d terms t e r m s in i n the t h e quoted q u o t e d items i t e m s are a r e terms t e r m s that t h a t are a r e defined d e f i n e d in i n the t h e other o t h e r standard, s t a n d a r d , not n o t defined d e f i n e d terms t e r m s in i n this t h i s standard. s t a n d a r d . Medical M e d i c a l device d e v i c e management m a n a g e m e n t Lays L a y s standards s t a n d a r d s out o u t a a foundation f o u n d a t i o n ISO I S O 14971 1 4 9 7 1 to t o ISO I S O 13485 1 3 4 8 5 develop d e v e l o p a a medical m e d i c a l device d e v i c e affects a f f e c t s affects a f f e c t s Medical M e d i c a l device d e v i c e product p r o d u c t standards s t a n d a r d s IEC I E C 60601-1 6 0 6 0 1 - 1 IEC I E C 61010-1 6 1 0 1 0 - 1 IEC I E C 82304-1 8 2 3 0 4 - 1 requires r e q u i r e s Gives G i v e s specific s p e c i f i c direction d i r e c t i o n for f o r creation c r e a t i o n of o f a a safe s a f e medical m e d i c a l device d e v i c e Medical M e d i c a l device d e v i c e process p r o c e s s standards s t a n d a r d s IEC I E C 62304 6 2 3 0 4 IEC I E C 62366-1 6 2 3 6 6 - 1 affects a f f e c t s Implementation I m p l e m e n t a t i o n of o f medical m e d i c a l device d e v i c e software s o f t w a r e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Gives G i v e s detailed d e t a i l e d direction d i r e c t i o n how h o w to t o develop d e v e l o p and a n d maintain m a i n t a i n safe s a f e software s o f t w a r e system s y s t e m Other O t h e r sources s o u r c e s of o f information i n f o r m a t i o n IEC/ISO I E C / I S O 12207 1 2 2 0 7 IEC I E C 61508-3 6 1 5 0 8 - 3 IEC/ISO I E C / I S O 90003, 9 0 0 0 3 , ... . . . inspires i n s p i r e s Gives G i v e s additional a d d i t i o n a l guidelines, g u i d e l i n e s , techniques, t e c h n i q u e s , etc e t c that t h a t may m a y be b e used u s e d IEC I E C Figure F i g u r e C.1 C . 1 – – Relationship R e l a t i o n s h i p of o f key k e y MEDICAL M E D I C A L DEVICE D E V I C E standards s t a n d a r d s to t o IEC I E C 62304 6 2 3 0 4 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 57 5 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 C.2 C . 2 Relationship R e l a t i o n s h i p to t o ISO I S O 13485 1 3 4 8 5 This T h i s standard s t a n d a r d requires r e q u i r e s that t h a t the t h e MANUFACTURER M A N U F A C T U R E R employs e m p l o y s a a quality q u a l i t y management m a n a g e m e n t system. s y s t e m . When W h e n a a MANUFACTURER M A N U F A C T U R E R uses u s e s ISO I S O 13485 1 3 4 8 5 [8], [ 8 ] , the t h e requirements r e q u i r e m e n t s of o f ISO I S O 62304 6 2 3 0 4 directly d i r e c t l y relate r e l a t e to t o some s o m e of o f the t h e requirements r e q u i r e m e n t s of o f ISO I S O 13485 1 3 4 8 5 as a s shown s h o w n in i n Table T a b l e C.1. C . 1 . Table T a b l e C.1 C . 1 – – Relationship R e l a t i o n s h i p to t o ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 IEC I E C 62304 6 2 3 0 4 clause c l a u s e Related R e l a t e d clause c l a u s e of o f ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 7.3.1 7 . 3 . 1 Design D e s i g n and a n d development d e v e l o p m e n t planning p l a n n i n g 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.3.2 7 . 3 . 2 Design D e s i g n and a n d development d e v e l o p m e n t inputs i n p u t s 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.3.3 7 . 3 . 3 Design D e s i g n and a n d development d e v e l o p m e n t outputs o u t p u t s 7.3.4 7 . 3 . 4 Design D e s i g n and a n d development d e v e l o p m e n t review r e v i e w 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 7.3.7 7 . 3 . 7 Control C o n t r o l of o f design d e s i g n and a n d development d e v e l o p m e n t changes c h a n g e s 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d TRACEABILITY T R A C E A B I L I T Y 8.2 8 . 2 Change C h a n g e control c o n t r o l 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d TRACEABILITY T R A C E A B I L I T Y 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S C.3 C . 3 Relationship R e l a t i o n s h i p to t o ISO I S O 14971 1 4 9 7 1 Table T a b l e C.2 C . 2 shows s h o w s the t h e areas a r e a s where w h e r e IEC I E C 62304 6 2 3 0 4 amplifies a m p l i f i e s requirements r e q u i r e m e n t s for f o r the t h e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S required r e q u i r e d by b y ISO I S O 14971. 1 4 9 7 1 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 58 5 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.2 C . 2 – – Relationship R e l a t i o n s h i p to t o ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 clause c l a u s e Related R e l a t e d clause c l a u s e of o f IEC I E C 62304 6 2 3 0 4 4.1 4 . 1 RISK R I S K ANALYSIS A N A L Y S I S process p r o c e s s 4.2 4 . 2 Intended I n t e n d e d use u s e and a n d identification i d e n t i f i c a t i o n of o f characteristics c h a r a c t e r i s t i c s related r e l a t e d to t o the t h e SAFETY S A F E T Y of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E 4.3 4 . 3 Identification I d e n t i f i c a t i o n of o f HAZARDS H A Z A R D S 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S 4.4 4 . 4 Estimation E s t i m a t i o n of o f the t h e RISK(S) R I S K ( S ) for f o r each e a c h HAZARDOUS H A Z A R D O U S SITUATION S I T U A T I O N 4.3 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n 5 5 RISK R I S K evaluation e v a l u a t i o n 6.1 6 . 1 RISK R I S K reduction r e d u c t i o n 6.2 6 . 2 RISK R I S K CONTROL C O N T R O L option o p t i o n analysis a n a l y s i s 7.2.1 7 . 2 . 1 Define D e f i n e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 6.3 6 . 3 Implementation I m p l e m e n t a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 7.2.2 7 . 2 . 2 6.4 6 . 4 RESIDUAL R E S I D U A L RISK R I S K evaluation e v a l u a t i o n 6.5 6 . 5 RISK/benefit R I S K / b e n e f i t analysis a n a l y s i s 7.3.1 7 . 3 . 1 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d in i n software s o f t w a r e Verify V e r i f y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s 6.6 6 . 6 RISKS R I S K S arising a r i s i n g from f r o m RISK R I S K CONTROL C O N T R O L MEASURES M E A S U R E S 7.3.2 7 . 3 . 2 Document D o c u m e n t any a n y new n e w sequences s e q u e n c e s of o f events e v e n t s 6.7 6 . 7 Completeness C o m p l e t e n e s s of o f RISK R I S K CONTROL C O N T R O L 7 7 Evaluation E v a l u a t i o n of o f overall o v e r a l l RESIDUAL R E S I D U A L RISK R I S K acceptability a c c e p t a b i l i t y 8 8 RISK R I S K MANAGEMENT M A N A G E M E N T report r e p o r t 7.3.3 7 . 3 . 3 Document D o c u m e n t TRACEABILITY T R A C E A B I L I T Y 9 9 Production P r o d u c t i o n and a n d post-production p o s t - p r o d u c t i o n information i n f o r m a t i o n 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s C.4 C . 4 Relationship R e l a t i o n s h i p to t o PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 606011:2005/AMD1:2012 6 0 6 0 1 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 C.4.1 C . 4 . 1 General G e n e r a l Requirements R e q u i r e m e n t s for f o r software s o f t w a r e are a r e a a subset s u b s e t of o f the t h e requirements r e q u i r e m e n t s for f o r a a programmable p r o g r a m m a b l e electrical e l e c t r i c a l medical m e d i c a l system s y s t e m (PEMS). ( P E M S ) . This T h i s standard s t a n d a r d identifies i d e n t i f i e s requirements r e q u i r e m e n t s for f o r software s o f t w a r e which w h i c h are a r e in i n addition a d d i t i o n to, t o , but b u t not n o t incompatible i n c o m p a t i b l e with, w i t h , the t h e requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601- 6 0 6 0 1 - 1:2005 1 : 2 0 0 5 /AMD1:2012 / A M D 1 : 2 0 1 2 [1] [ 1 ] for f o r PEMS. P E M S . Because B e c a u s e PEMS P E M S include i n c l u d e elements e l e m e n t s that t h a t are a r e not n o t software, s o f t w a r e , not n o t all a l l of o f the t h e requirements r e q u i r e m e n t s of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 for f o r PEMS P E M S are a r e addressed a d d r e s s e d in i n this t h i s standard. s t a n d a r d . With W i t h the t h e publication p u b l i c a t i o n of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601- 6 0 6 0 1 - 1:2005 1 : 2 0 0 5 /AMD1:2012, / A M D 1 : 2 0 1 2 , IEC I E C 62304 6 2 3 0 4 is i s now n o w a a normative n o r m a t i v e reference r e f e r e n c e of o f IEC I E C 60601-1 6 0 6 0 1 - 1 and a n d compliance c o m p l i a n c e with w i t h Clause C l a u s e 14 1 4 of o f IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 (and ( a n d thus t h u s compliance c o m p l i a n c e with w i t h the t h e standard) s t a n d a r d ) requires r e q u i r e s compliance c o m p l i a n c e with w i t h parts p a r t s of o f IEC I E C 62304 6 2 3 0 4 (not ( n o t with w i t h the t h e whole w h o l e of o f IEC I E C 62304 6 2 3 0 4 because b e c a u s e IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 does d o e s not n o t require r e q u i r e compliance c o m p l i a n c e with w i t h post-production p o s t - p r o d u c t i o n and a n d maintenance m a i n t e n a n c e requirements r e q u i r e m e n t s of o f IEC I E C 62304). 6 2 3 0 4 ) . Finally, F i n a l l y , it i t is i s important i m p o r t a n t to t o remember r e m e m b e r that t h a t IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 is i s only o n l y used u s e d if i f the t h e software s o f t w a r e is i s part p a r t of o f a a PEMS P E M S and a n d not n o t if i f the t h e software s o f t w a r e is i s itself i t s e l f a a MEDICAL M E D I C A L DEVICE. D E V I C E . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . C.4.2 C . 4 . 2 Software S o f t w a r e relationship r e l a t i o n s h i p to t o PEMS P E M S development d e v e l o p m e n t By B y using u s i n g the t h e V-model V - m o d e l illustrated i l l u s t r a t e d in i n Figure F i g u r e C.2 C . 2 to t o describe d e s c r i b e what w h a t occurs o c c u r s during d u r i n g a a PEMS P E M S development, d e v e l o p m e n t , it i t can c a n be b e seen s e e n that t h a t the t h e requirements r e q u i r e m e n t s of o f this t h i s software s o f t w a r e standard s t a n d a r d apply a p p l y at a t the t h e PEMS P E M S component c o m p o n e n t level, l e v e l , from f r o m the t h e specification s p e c i f i c a t i o n of o f the t h e software s o f t w a r e requirements r e q u i r e m e n t s to t o the t h e integration i n t e g r a t i o n of o f the t h e SOFTWARE S O F T W A R E ITEMS I T E M S into i n t o a a SOFTWARE S O F T W A R E SYSTEM. S Y S T E M . This T h i s SOFTWARE S O F T W A R E SYSTEM S Y S T E M is i s a a part p a r t of o f a a programmable p r o g r a m m a b l e electrical e l e c t r i c a l subsystem s u b s y s t e m (PESS), ( P E S S ) , which w h i c h is i s a a part p a r t of o f a a PEMS. P E M S . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 59 5 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 User U s e r needs n e e d s Validated V a l i d a t e d PEMS P E M S PEMS P E M S requirements r e q u i r e m e n t s capture c a p t u r e PEMS P E M S validation v a l i d a t i o n plan p l a n PEMS P E M S validation v a l i d a t i o n PEMS P E M S validation v a l i d a t i o n results r e s u l t s PEMS P E M S requirement r e q u i r e m e n t specifications s p e c i f i c a t i o n s Verified V e r i f i e d PEMS P E M S PEMS P E M S architectural a r c h i t e c t u r a l design d e s i g n PEMS P E M S VERIFICATION V E R I F I C A T I O N Plan P l a n PEMS P E M S test t e s t specification s p e c i f i c a t i o n PEMS P E M S integration i n t e g r a t i o n & & VERIFICATION V E R I F I C A T I O N PEMS P E M S VERIFICATION V E R I F I C A T I O N results r e s u l t s PEMS P E M S architecture a r c h i t e c t u r e specification, s p e c i f i c a t i o n , Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) requirements r e q u i r e m e n t s specifications s p e c i f i c a t i o n s Verified V e r i f i e d Subsystem S u b s y s t e m Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) architectural a r c h i t e c t u r a l design d e s i g n Subsystem S u b s y s t e m test t e s t specification s p e c i f i c a t i o n Subsystem S u b s y s t e m (e.g. ( e . g . PESS) P E S S ) integration i n t e g r a t i o n & & VERIFICATION V E R I F I C A T I O N Subsystem S u b s y s t e m VERIFICATION V E R I F I C A T I O N results r e s u l t s Software S o f t w a r e requirements r e q u i r e m e n t s specifications s p e c i f i c a t i o n s (component ( c o m p o n e n t requirements) r e q u i r e m e n t s ) Verified V e r i f i e d software s o f t w a r e subsystem s u b s y s t e m (component) ( c o m p o n e n t ) Software S o f t w a r e integration i n t e g r a t i o n & & SOFTWARE S O F T W A R E SYSTEM S Y S T E M VERIFICATION V E R I F I C A T I O N Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n (component ( c o m p o n e n t design) d e s i g n ) (component ( c o m p o n e n t integration i n t e g r a t i o n & & verification) v e r i f i c a t i o n ) Software S o f t w a r e integration i n t e g r a t i o n and a n d VERIFICATION V E R I F I C A T I O N Software S o f t w a r e test t e s t specifications s p e c i f i c a t i o n s results r e s u l t s Portion P o r t i o n of o f PEMS P E M S V-model V - m o d e l included i n c l u d e d in i n IEC I E C 62304 6 2 3 0 4 Software S o f t w a r e ARCHITECTURE A R C H I T E C T U R E specification s p e c i f i c a t i o n Verified V e r i f i e d code c o d e Software S o f t w a r e detailed d e t a i l e d design d e s i g n (unit ( u n i t design) d e s i g n ) Software S o f t w a r e unit u n i t Software S o f t w a r e unit u n i t implementationVERIFICATION i m p l e m e n t a t i o n V E R I F I C A T I O N (unit ( u n i t VERIFICATION) V E R I F I C A T I O N ) Unit U n i t VERIFICATIO V E R I F I C A T I O results r e s u l t s N N Key: K e y : Boxes B o x e s represent r e p r e s e n t typical t y p i c a l development d e v e l o p m e n t lifecycle l i f e c y c l e activities a c t i v i t i e s Solid S o l i d Arrows A r r o w s indicate i n d i c a t e typical t y p i c a l deliverables d e l i v e r a b l e s transfered t r a n s f e r e d into/out i n t o / o u t of o f activities a c t i v i t i e s Dotted D o t t e d arrows a r r o w s indicate i n d i c a t e deliverables d e l i v e r a b l e s just j u s t to t o the t h e Risk R i s k Management M a n a g e m e n t File F i l e Outputs O u t p u t s from f r o m problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s Inputs I n p u t s to t o problem p r o b l e m resolution r e s o l u t i o n process p r o c e s s IEC I E C 726/06 7 2 6 / 0 6 Figure F i g u r e C.2 C . 2 – – Software S o f t w a r e as a s part p a r t of o f the t h e V-model V - m o d e l C.4.3 C . 4 . 3 Development D e v e l o p m e n t PROCESS P R O C E S S Compliance C o m p l i a n c e with w i t h the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S of o f this t h i s standard s t a n d a r d (Clause ( C l a u s e 5) 5 ) requires r e q u i r e s that t h a t a a software s o f t w a r e development d e v e l o p m e n t plan p l a n be b e specified s p e c i f i e d and a n d then t h e n followed; f o l l o w e d ; it i t does d o e s not n o t require r e q u i r e that t h a t any a n y particular p a r t i c u l a r life l i f e cycle c y c l e model m o d e l is i s used, u s e d , but b u t it i t does d o e s require r e q u i r e that t h a t the t h e plan p l a n include i n c l u d e certain c e r t a i n ACTIVITIES A C T I V I T I E S and a n d have h a v e certain c e r t a i n attributes. a t t r i b u t e s . These T h e s e requirements r e q u i r e m e n t s relate r e l a t e to t o the t h e PEMS P E M S requirements r e q u i r e m e n t s in i n IEC I E C 60601-1 6 0 6 0 1 - 1 for f o r development d e v e l o p m e n t life l i f e cycle, c y c l e , requirement r e q u i r e m e n t specification, s p e c i f i c a t i o n , ARCHITECTURE, A R C H I T E C T U R E , design d e s i g n and a n d implementation, i m p l e m e n t a t i o n , and a n d VERIFICATION. V E R I F I C A T I O N . The T h e requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d provide p r o v i d e greater g r e a t e r detail d e t a i l about a b o u t software s o f t w a r e development d e v e l o p m e n t than t h a n those t h o s e in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . C.4.4 C . 4 . 4 Maintenance M a i n t e n a n c e PROCESS P R O C E S S Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Compliance C o m p l i a n c e with w i t h the t h e software s o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S of o f this t h i s standard s t a n d a r d (Clause ( C l a u s e 6) 6 ) requires r e q u i r e s that t h a t procedures p r o c e d u r e s be b e established e s t a b l i s h e d and a n d followed f o l l o w e d when w h e n changes c h a n g e s to t o software s o f t w a r e are a r e made. m a d e . These T h e s e require- r e q u i r e - ments m e n t s correspond c o r r e s p o n d to t o the t h e requirement r e q u i r e m e n t in i n IEC I E C 60601-1 6 0 6 0 1 - 1 for f o r modification m o d i f i c a t i o n of o f a a PEMS. P E M S . The T h e requirements r e q u i r e m e n t s in i n this t h i s standard s t a n d a r d for f o r software s o f t w a r e maintenance m a i n t e n a n c e provide p r o v i d e greater g r e a t e r detail d e t a i l about a b o u t what w h a t must m u s t be b e done d o n e for f o r software s o f t w a r e maintenance m a i n t e n a n c e than t h a n the t h e requirements r e q u i r e m e n t s for f o r PEMS P E M S modification m o d i f i c a t i o n in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . C.4.5 C . 4 . 5 Other O t h e r PROCESSES P R O C E S S E S The T h e other o t h e r PROCESSES P R O C E S S E S in i n this t h i s standard s t a n d a r d specify s p e c i f y additional a d d i t i o n a l requirements r e q u i r e m e n t s for f o r software s o f t w a r e beyond b e y o n d the t h e similar s i m i l a r requirements r e q u i r e m e n t s for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . In I n most m o s t cases, c a s e s , there t h e r e is i s a a general g e n e r a l requirement r e q u i r e m e n t for f o r PEMS P E M S in i n IEC I E C 60601-1, 6 0 6 0 1 - 1 , which w h i c h the t h e PROCESSES P R O C E S S E S in i n this t h i s standard s t a n d a r d expand e x p a n d upon. u p o n . The T h e software s o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d corresponds c o r r e s p o n d s to t o the t h e additional a d d i t i o n a l RISK R I S K MANAGEMENT M A N A G E M E N T requirements r e q u i r e m e n t s identified i d e n t i f i e d for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 60 6 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 The T h e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d corresponds c o r r e s p o n d s to t o the t h e problem p r o b l e m resolution r e s o l u t i o n requirement r e q u i r e m e n t for f o r PEMS P E M S in i n IEC I E C 60601-1. 6 0 6 0 1 - 1 . The T h e software s o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S in i n this t h i s standard s t a n d a r d specifies s p e c i f i e s additional a d d i t i o n a l requirements r e q u i r e m e n t s that t h a t are a r e not n o t present p r e s e n t for f o r PEMS P E M S in i n IEC I E C 60601-1 6 0 6 0 1 - 1 except e x c e p t for f o r documentation. d o c u m e n t a t i o n . C.4.6 C . 4 . 6 Coverage C o v e r a g e of o f PEMS P E M S requirements r e q u i r e m e n t s in i n IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 + + IEC I E C 606011:2005 6 0 6 0 1 1 : 2 0 0 5 /AMD1:2012 / A M D 1 : 2 0 1 2 Table T a b l e C.3 C . 3 shows s h o w s the t h e PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1 6 0 6 0 1 - 1 and a n d the t h e corresponding c o r r e s p o n d i n g requirements r e q u i r e m e n t s in i n this t h i s standard. s t a n d a r d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 61 6 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.3 C . 3 – – Relationship R e l a t i o n s h i p to t o IEC I E C 60601-1 6 0 6 0 1 - 1 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.1 1 4 . 1 General G e n e r a l The T h e requirements r e q u i r e m e n t s in i n 14.2 1 4 . 2 to t o 14.12 1 4 . 1 2 (inclusive) ( i n c l u s i v e ) shall s h a l l apply a p p l y to t o PEMS P E M S unless: u n l e s s : – – none n o n e of o f the t h e PROGRAMMABLE P R O G R A M M A B L E ELECTRONIC E L E C T R O N I C SUBSYSTEMS S U B S Y S T E M S (PESS) ( P E S S ) provides p r o v i d e s functionality f u n c t i o n a l i t y necessary n e c e s s a r y for f o r BASIC B A S I C SAFETY S A F E T Y or o r ESSENTIAL E S S E N T I A L PERFORMANCE; P E R F O R M A N C E ; or o r – – the t h e application a p p l i c a t i o n of o f RISK R I S K MANAGEMENT M A N A G E M E N T as a s described d e s c r i b e d in i n 4.2 4 . 2 demonstrates d e m o n s t r a t e s that t h a t the t h e failure f a i l u r e of o f the t h e PESS P E S S does d o e s not n o t lead l e a d to t o an a n unacceptable u n a c c e p t a b l e RISK. R I S K . The T h e requirements r e q u i r e m e n t s in i n 14.13 1 4 . 1 3 are a r e applicable a p p l i c a b l e to t o any a n y PEMS P E M S intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K whether w h e t h e r or o r not n o t the t h e requirements r e q u i r e m e n t s in i n 14.2 1 4 . 2 to t o 14.12 1 4 . 1 2 apply. a p p l y . When W h e n the t h e requirements r e q u i r e m e n t s in i n 14.2 1 4 . 2 to t o 14.13 1 4 . 1 3 apply, a p p l y , the t h e requirements r e q u i r e m e n t s in i n subclause s u b c l a u s e 4.3, 4 . 3 , Clause C l a u s e 5, 5 , Clause C l a u s e 7, 7 , Clause C l a u s e 8 8 and a n d Clause C l a u s e 9 9 of o f IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 shall s h a l l also a l s o apply a p p l y to t o the t h e development d e v e l o p m e n t or o r modification m o d i f i c a t i o n of o f software s o f t w a r e for f o r each e a c h PESS. P E S S . 14.2 1 4 . 2 Documentation D o c u m e n t a t i o n The T h e documents d o c u m e n t s required r e q u i r e d by b y Clause C l a u s e 14 1 4 shall s h a l l be b e reviewed, r e v i e w e d , approved, a p p r o v e d , issued i s s u e d and a n d changed c h a n g e d in i n accordance a c c o r d a n c e with w i t h a a formal f o r m a l document d o c u m e n t control c o n t r o l procedure. p r o c e d u r e . 14.3 1 4 . 3 RISK R I S K MANAGEMENT M A N A G E M E N T PLAN P L A N The T h e RISK R I S K MANAGEMENT M A N A G E M E N T plan p l a n required r e q u i r e d by b y 4.2.2 4 . 2 . 2 shall s h a l l also a l s o include i n c l u d e a a reference r e f e r e n c e to t o the t h e PEMS P E M S VALIDATION V A L I D A T I O N plan p l a n (see ( s e e 14.11). 1 4 . 1 1 ) . 14.4 1 4 . 4 PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E A A PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l be b e documented. d o c u m e n t e d . The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l contain c o n t a i n a a set s e t of o f defined d e f i n e d milestones. m i l e s t o n e s . At A t each e a c h milestone, m i l e s t o n e , the t h e ACTIVITIES A C T I V I T I E S to t o be b e completed c o m p l e t e d and a n d the t h e VERIFICATION V E R I F I C A T I O N methods m e t h o d s to t o be b e applied a p p l i e d to t o those t h o s e activities a c t i v i t i e s shall s h a l l be b e defined. d e f i n e d . Each E a c h activity a c t i v i t y shall s h a l l be b e defined d e f i n e d including i n c l u d i n g its i t s inputs i n p u t s and a n d outputs. o u t p u t s . 4.3 4 . 3 Software S o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n The T h e PEMS P E M S requirements r e q u i r e m e n t s of o f IEC I E C 60601-1 6 0 6 0 1 - 1 would w o u l d only o n l y apply a p p l y to t o software s o f t w a r e safety s a f e t y classes c l a s s e s B B and a n d C. C . This T h i s standard s t a n d a r d includes i n c l u d e s some s o m e requirements r e q u i r e m e n t s for f o r software s o f t w a r e safety s a f e t y class c l a s s A. A . The T h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S required r e q u i r e d for f o r compliance c o m p l i a n c e with w i t h IEC I E C 60601-1 6 0 6 0 1 - 1 does d o e s not n o t include i n c l u d e the t h e post p o s t production p r o d u c t i o n monitoring m o n i t o r i n g and a n d maintenance m a i n t e n a n c e required r e q u i r e d by b y Clause C l a u s e 6 6 of o f IEC I E C 62304:2006. 6 2 3 0 4 : 2 0 0 6 . 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g In I n addition a d d i t i o n to t o the t h e specific s p e c i f i c requirements r e q u i r e m e n t s in i n the t h e software s o f t w a r e development d e v e l o p m e n t planning p l a n n i n g ACTIVITY, A C T I V I T Y , documents d o c u m e n t s that t h a t are a r e part p a r t of o f the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE F I L E are a r e required r e q u i r e d to t o be b e maintained m a i n t a i n e d by b y ISO I S O 14971. 1 4 9 7 1 . In I n addition, a d d i t i o n , for f o r documents d o c u m e n t s that t h a t are a r e required r e q u i r e d by b y the t h e quality q u a l i t y system, s y s t e m , ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] requires r e q u i r e s control c o n t r o l of o f the t h e documents. d o c u m e n t s . Not N o t specifically s p e c i f i c a l l y required. r e q u i r e d . There T h e r e is i s no n o specific s p e c i f i c software s o f t w a r e validation v a l i d a t i o n plan. p l a n . The T h e PEMS P E M S validation v a l i d a t i o n plan p l a n is i s at a t the t h e SYSTEM S Y S T E M level l e v e l and a n d thus t h u s is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s software s o f t w a r e standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s require r e q u i r e TRACEABILITY T R A C E A B I L I T Y from f r o m HAZARD H A Z A R D to t o specific s p e c i f i c software s o f t w a r e cause c a u s e to t o RISK R I S K CONTROL C O N T R O L measure m e a s u r e to t o VERIFICATION V E R I F I C A T I O N of o f the t h e RISK R I S K CONTROL C O N T R O L measure m e a s u r e (see ( s e e 7.3) 7 . 3 ) 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n The T h e items i t e m s addressed a d d r e s s e d by b y the t h e software s o f t w a r e development d e v e l o p m e n t plan p l a n constitute c o n s t i t u t e a a SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE. C Y C L E . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g VERIFICATION V E R I F I C A T I O N TASKS, T A S K S , milestones m i l e s t o n e s and a n d acceptance a c c e p t a n c e criteria c r i t e r i a must m u s t be b e planned. p l a n n e d . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n ACTIVITIES A C T I V I T I E S are a r e defined d e f i n e d in i n this t h i s standard. s t a n d a r d . Documentation D o c u m e n t a t i o n to t o be b e produced p r o d u c e d is i s defined d e f i n e d in i n each e a c h ACTIVITY. A C T I V I T Y . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Each E a c h milestone m i l e s t o n e shall s h a l l identify i d e n t i f y the t h e RISK R I S K MANAGEMENT M A N A G E M E N T ACTIVITIES A C T I V I T I E S that t h a t must m u s t be b e completed c o m p l e t e d before b e f o r e that t h a t milestone. m i l e s t o n e . The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l be b e tailored t a i l o r e d for f o r a a specific s p e c i f i c development d e v e l o p m e n t by b y making m a k i n g plans p l a n s which w h i c h detail d e t a i l ACTIVITIES, A C T I V I T I E S , milestones m i l e s t o n e s and a n d schedules. s c h e d u l e s . The T h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE L I F E - C Y C L E shall s h a l l include i n c l u d e documentation d o c u m e n t a t i o n requirements. r e q u i r e m e n t s . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n This T h i s standard s t a n d a r d allows a l l o w s the t h e development d e v e l o p m e n t life l i f e cycle c y c l e to t o be b e documented d o c u m e n t e d in i n the t h e development d e v e l o p m e n t plan. p l a n . This T h i s means m e a n s the t h e development d e v e l o p m e n t plan p l a n contains c o n t a i n s a a tailored t a i l o r e d development d e v e l o p m e n t life l i f e cycle. c y c l e . 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 62 6 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.5 1 4 . 5 Problem P r o b l e m resolution r e s o l u t i o n Where W h e r e appropriate, a p p r o p r i a t e , a a documented d o c u m e n t e d system s y s t e m for f o r problem p r o b l e m resolution r e s o l u t i o n within w i t h i n and a n d between b e t w e e n all a l l phases p h a s e s and a n d ACTIVITIES A C T I V I T I E S of o f the t h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE- L I F E - CYCLE C Y C L E shall s h a l l be b e developed d e v e l o p e d and a n d maintained. m a i n t a i n e d . Depending D e p e n d i n g on o n the t h e type t y p e of o f product, p r o d u c t , the t h e problem p r o b l e m resolution r e s o l u t i o n SYSTEM S Y S T E M may: m a y : � be b e documented d o c u m e n t e d as a s a a part p a r t of o f the t h e PEMS P E M S DEVELOPMENT D E V E L O P M E N T LIFE-CYCLE; L I F E - C Y C L E ; � allow a l l o w the t h e reporting r e p o r t i n g of o f potential p o t e n t i a l or o r existing e x i s t i n g problems p r o b l e m s affecting a f f e c t i n g BASIC B A S I C SAFETY S A F E T Y or o r ESSENTIAL E S S E N T I A L PERFORMANCE; P E R F O R M A N C E ; � include i n c l u d e an a n assessment a s s e s s m e n t of o f each e a c h problem p r o b l e m for f o r associated a s s o c i a t e d RISKS; R I S K S ; � identify i d e n t i f y the t h e criteria c r i t e r i a that t h a t must m u s t be b e met m e t for f o r the t h e issue i s s u e to t o be b e closed; c l o s e d ; � identify i d e n t i f y the t h e action a c t i o n to t o be b e taken t a k e n to t o resolve r e s o l v e each e a c h problem. p r o b l e m . 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S 14.6 1 4 . 6 RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 14.6.1 1 4 . 6 . 1 Identification I d e n t i f i c a t i o n of o f known k n o w n and a n d foreseeable f o r e s e e a b l e HAZARDS H A Z A R D S When W h e n compiling c o m p i l i n g the t h e list l i s t of o f known k n o w n or o r foreseeable f o r e s e e a b l e HAZARDS, H A Z A R D S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l consider c o n s i d e r those t h o s e HAZARDS H A Z A R D S associated a s s o c i a t e d with w i t h software s o f t w a r e and a n d hardware h a r d w a r e aspects a s p e c t s of o f the t h e PEMS P E M S including i n c l u d i n g those t h o s e associated a s s o c i a t e d with w i t h the t h e incorporation i n c o r p o r a t i o n of o f the t h e PEMS P E M S into i n t o an a n IT-NETWORK, I T - N E T W O R K , components c o m p o n e n t s of o f third-party t h i r d - p a r t y origin o r i g i n and a n d legacy l e g a c y subsystems. s u b s y s t e m s . 14.6.2 1 4 . 6 . 2 RISK R I S K CONTROL C O N T R O L Suitably S u i t a b l y validated v a l i d a t e d tools t o o l s and a n d PROCEDURES P R O C E D U R E S shall s h a l l be b e selected s e l e c t e d and a n d identified i d e n t i f i e d to t o implement i m p l e m e n t each e a c h RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . These T h e s e tools t o o l s and a n d PROCEDURES P R O C E D U R E S shall s h a l l be b e appropriate a p p r o p r i a t e to t o assure a s s u r e that t h a t each e a c h RISK R I S K CONTROL C O N T R O L measure m e a s u r e satisfactorily s a t i s f a c t o r i l y reduces r e d u c e s the t h e identified i d e n t i f i e d RISK(S). R I S K ( S ) . 14.7 1 4 . 7 Requirements R e q u i r e m e n t s specification s p e c i f i c a t i o n For F o r the t h e PEMS P E M S and a n d each e a c h of o f its i t s subsystems s u b s y s t e m s (e.g. ( e . g . for f o r a a PESS) P E S S ) there t h e r e shall s h a l l be b e a a documented d o c u m e n t e d requirement r e q u i r e m e n t specification. s p e c i f i c a t i o n . The T h e requirement r e q u i r e m e n t specification s p e c i f i c a t i o n for f o r a a system s y s t e m or o r subsystem s u b s y s t e m shall s h a l l include i n c l u d e and a n d distinguish d i s t i n g u i s h any a n y ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E and a n d any a n y RISK R I S K CONTROL C O N T R O L measures m e a s u r e s implemented i m p l e m e n t e d by b y that t h a t system s y s t e m or o r subsystem. s u b s y s t e m . 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S This T h i s standard s t a n d a r d does d o e s not n o t mention m e n t i o n network/data n e t w o r k / d a t a coupling c o u p l i n g specifically s p e c i f i c a l l y 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g This T h i s standard s t a n d a r d requires r e q u i r e s the t h e identification i d e n t i f i c a t i o n of o f specific s p e c i f i c tools t o o l s and a n d methods m e t h o d s to t o be b e used u s e d for f o r development d e v e l o p m e n t in i n general, g e n e r a l , not n o t for f o r each e a c h RISK R I S K CONTROL C O N T R O L measure. m e a s u r e . 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s This T h i s standard s t a n d a r d deals d e a l s only o n l y with w i t h the t h e software s o f t w a r e subsystems s u b s y s t e m s of o f a a PEMS. P E M S . 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements. r e q u i r e m e n t s . 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t the t h e requirements r e q u i r e m e n t s related r e l a t e d to t o essential e s s e n t i a l performance p e r f o r m a n c e and a n d RISK R I S K CONTROL C O N T R O L measures m e a s u r e s be b e distinguished d i s t i n g u i s h e d from f r o m other o t h e r requirements, r e q u i r e m e n t s , but b u t it i t does d o e s require r e q u i r e that t h a t all a l l requirements r e q u i r e m e n t s be b e uniquely u n i q u e l y identified. i d e n t i f i e d . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 63 6 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.8 1 4 . 8 ARCHITECTURE A R C H I T E C T U R E For F o r the t h e PEMS P E M S and a n d each e a c h of o f its i t s subsystems, s u b s y s t e m s , an a n ARCHITECTURE A R C H I T E C T U R E shall s h a l l be b e specified s p e c i f i e d that t h a t shall s h a l l satisfy s a t i s f y the t h e requirements r e q u i r e m e n t s specification. s p e c i f i c a t i o n . Where W h e r e appropriate, a p p r o p r i a t e , to t o reduce r e d u c e the t h e RISK R I S K to t o an a n acceptable a c c e p t a b l e level, l e v e l , the t h e architecture a r c h i t e c t u r e specification s p e c i f i c a t i o n shall s h a l l make m a k e use u s e of: o f : a) a ) COMPONENTS C O M P O N E N T S WITH W I T H HIGH-INTEGRITY H I G H - I N T E G R I T Y CHARACTERISTICS; C H A R A C T E R I S T I C S ; fail-safe f a i l - s a f e functions; f u n c t i o n s ; redundancy; r e d u n d a n c y ; diversity; d i v e r s i t y ; partitioning p a r t i t i o n i n g of o f functionality; f u n c t i o n a l i t y ; defensive d e f e n s i v e design, d e s i g n , e.g. e . g . limits l i m i t s on o n potentially p o t e n t i a l l y hazardous h a z a r d o u s effects e f f e c t s by b y restricting r e s t r i c t i n g the t h e available a v a i l a b l e output o u t p u t power p o w e r or o r by b y introducing i n t r o d u c i n g means m e a n s to t o limit l i m i t the t h e travel t r a v e l of o f actuators. a c t u a t o r s . 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L Partitioning P a r t i t i o n i n g is i s the t h e only o n l y technique t e c h n i q u e identified, i d e n t i f i e d , and a n d it i t is i s only o n l y identified i d e n t i f i e d because b e c a u s e there t h e r e is i s a a requirement r e q u i r e m e n t to t o state s t a t e how h o w the t h e integrity i n t e g r i t y of o f the t h e partitioning p a r t i t i o n i n g is i s assured. a s s u r e d . The T h e ARCHITECTURE A R C H I T E C T U R E specification s p e c i f i c a t i o n shall s h a l l take t a k e into i n t o consideration: c o n s i d e r a t i o n : allocation a l l o c a t i o n of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s to t o subsystems s u b s y s t e m s and a n d components c o m p o n e n t s of o f the t h e PEMS; P E M S ; failure f a i l u r e modes m o d e s of o f components c o m p o n e n t s and a n d their t h e i r effects; e f f e c t s ; common c o m m o n cause c a u s e failures; f a i l u r e s ; systemic s y s t e m i c failures; f a i l u r e s ; test t e s t interval i n t e r v a l duration d u r a t i o n and a n d diagnostic d i a g n o s t i c coverage; c o v e r a g e ; maintainability; m a i n t a i n a b i l i t y ; protection p r o t e c t i o n from f r o m reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e misuse; m i s u s e ; the t h e IT-NETWORK I T - N E T W O R K specification, s p e c i f i c a t i o n , if i f applicable. a p p l i c a b l e . 14.9 1 4 . 9 Design D e s i g n and a n d implementation i m p l e m e n t a t i o n Where W h e r e appropriate, a p p r o p r i a t e , the t h e design d e s i g n shall s h a l l be b e decomposed d e c o m p o s e d into i n t o subsystems, s u b s y s t e m s , each e a c h having h a v i n g both b o t h a a design d e s i g n and a n d test t e s t specification. s p e c i f i c a t i o n . Descriptive D e s c r i p t i v e data d a t a regarding r e g a r d i n g the t h e design d e s i g n environment e n v i r o n m e n t shall s h a l l be b e included i n c l u d e d in i n the t h e documentation. d o c u m e n t a t i o n . 14.10 1 4 . 1 0 VERIFICATION V E R I F I C A T I O N VERIFICATION V E R I F I C A T I O N is i s required r e q u i r e d for f o r all a l l functions f u n c t i o n s that t h a t implement i m p l e m e n t BASIC B A S I C SAFETY, S A F E T Y , ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E or o r RISK R I S K CONTROL C O N T R O L measures. m e a s u r e s . This T h i s is i s not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e a a test t e s t specification s p e c i f i c a t i o n for f o r detailed d e t a i l e d design. d e s i g n . 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g VERIFICATION V E R I F I C A T I O N is i s required r e q u i r e d for f o r each e a c h ACTIVITY A C T I V I T Y Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 64 6 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S A A VERIFICATION V E R I F I C A T I O N plan p l a n shall s h a l l be b e produced p r o d u c e d to t o show s h o w how h o w these t h e s e functions f u n c t i o n s shall s h a l l be b e verified. v e r i f i e d . The T h e plan p l a n shall s h a l l include: i n c l u d e : � at a t which w h i c h milestone(s) m i l e s t o n e ( s ) VERIFICATION V E R I F I C A T I O N is i s to t o be b e performed p e r f o r m e d on o n each e a c h function; f u n c t i o n ; � the t h e selection s e l e c t i o n and a n d documentation d o c u m e n t a t i o n of o f VERIFICATION V E R I F I C A T I O N strategies, s t r a t e g i e s , ACTIVITIES, A C T I V I T I E S , techniques, t e c h n i q u e s , and a n d the t h e appropriate a p p r o p r i a t e level l e v e l of o f independence i n d e p e n d e n c e of o f the t h e personnel p e r s o n n e l performing p e r f o r m i n g the t h e VERIFICATION; V E R I F I C A T I O N ; � the t h e selection s e l e c t i o n and a n d utilization u t i l i z a t i o n of o f VERIFICATION V E R I F I C A T I O N tools; t o o l s ; � coverage c o v e r a g e criteria c r i t e r i a for f o r VERIFICATION. V E R I F I C A T I O N . 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g Independence I n d e p e n d e n c e of o f personnel p e r s o n n e l is i s not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . It I t is i s considered c o n s i d e r e d covered c o v e r e d in i n ISO I S O 13485. 1 3 4 8 5 . The T h e VERIFICATION V E R I F I C A T I O N shall s h a l l be b e performed p e r f o r m e d according a c c o r d i n g to t o the t h e VERIFICATION V E R I F I C A T I O N plan. p l a n . The T h e results r e s u l t s of o f the t h e VERIFICATION V E R I F I C A T I O N activities a c t i v i t i e s shall s h a l l be b e documented. d o c u m e n t e d . VERIFICATION V E R I F I C A T I O N requirements r e q u i r e m e n t s are a r e in i n most m o s t of o f the t h e ACTIVITIES. A C T I V I T I E S . 14.11 1 4 . 1 1 PEMS P E M S VALIDATION V A L I D A T I O N A A PEMS P E M S VALIDATION V A L I D A T I O N plan p l a n shall s h a l l include i n c l u d e the t h e validation v a l i d a t i o n of o f BASIC B A S I C SAFETY S A F E T Y and a n d ESSENTIAL E S S E N T I A L PERFORMANCE. P E R F O R M A N C E . Methods M e t h o d s used u s e d for f o r PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e documented d o c u m e n t e d The T h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e performed p e r f o r m e d according a c c o r d i n g to t o the t h e PEMS P E M S VALIDATION V A L I D A T I O N plan. p l a n . The T h e results r e s u l t s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N activities a c t i v i t i e s shall s h a l l be b e documented. d o c u m e n t e d . The T h e person p e r s o n having h a v i n g the t h e overall o v e r a l l responsibility r e s p o n s i b i l i t y for f o r the t h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e independent i n d e p e n d e n t of o f the t h e design d e s i g n team. t e a m . The T h e MANUFACTURER M A N U F A C T U R E R shall s h a l l document d o c u m e n t the t h e rationale r a t i o n a l e for f o r the t h e level l e v e l of o f independence. i n d e p e n d e n c e . No N o member m e m b e r of o f a a design d e s i g n team t e a m shall s h a l l be b e responsible r e s p o n s i b l e for f o r the t h e PEMS P E M S VALIDATION V A L I D A T I O N of o f their t h e i r own o w n design. d e s i g n . All A l l professional p r o f e s s i o n a l relationships r e l a t i o n s h i p s of o f the t h e members m e m b e r s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N team t e a m with w i t h members m e m b e r s of o f the t h e design d e s i g n team t e a m shall s h a l l be b e documented d o c u m e n t e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . A A reference r e f e r e n c e to t o the t h e methods m e t h o d s and a n d results r e s u l t s of o f the t h e PEMS P E M S VALIDATION V A L I D A T I O N shall s h a l l be b e included i n c l u d e d in i n the t h e RISK R I S K MANAGEMENT M A N A G E M E N T FILE. F I L E . 14.12 1 4 . 1 2 Modification M o d i f i c a t i o n If I f any a n y or o r all a l l of o f a a design d e s i g n results r e s u l t s from f r o m a a modification m o d i f i c a t i o n of o f an a n earlier e a r l i e r design d e s i g n then t h e n either e i t h e r all a l l of o f this t h i s clause c l a u s e applies a p p l i e s as a s if i f it i t were w e r e a a new n e w design d e s i g n or o r the t h e continued c o n t i n u e d validity v a l i d i t y of o f any a n y previous p r e v i o u s design d e s i g n documentation d o c u m e n t a t i o n shall s h a l l be b e assessed a s s e s s e d under u n d e r a a documented d o c u m e n t e d modification/change m o d i f i c a t i o n / c h a n g e PROCEDURE. P R O C E D U R E . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . This T h i s standard s t a n d a r d does d o e s not n o t cover c o v e r software s o f t w a r e validation. v a l i d a t i o n . PEMS P E M S validation v a l i d a t i o n is i s a a SYSTEM S Y S T E M level l e v e l ACTIVITY A C T I V I T Y and a n d is i s outside o u t s i d e the t h e scope s c o p e of o f this t h i s standard. s t a n d a r d . 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S This T h i s standard s t a n d a r d takes t a k e s the t h e approach a p p r o a c h that t h a t software s o f t w a r e maintenance m a i n t e n a n c e should s h o u l d be b e planned p l a n n e d and a n d that t h a t implementation i m p l e m e n t a t i o n of o f modifications m o d i f i c a t i o n s should s h o u l d use u s e the t h e software s o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S or o r an a n established e s t a b l i s h e d software s o f t w a r e maintenance m a i n t e n a n c e PROCESS. P R O C E S S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . When W h e n software s o f t w a r e is i s modified, m o d i f i e d , the t h e requirements r e q u i r e m e n t s in i n subclause s u b c l a u s e 4.3, 4 . 3 , Clause C l a u s e 5, 5 , Clause C l a u s e 7, 7 , Clause C l a u s e 8 8 and a n d Clause C l a u s e 9 9 of o f IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 shall s h a l l also a l s o apply a p p l y to t o the t h e modification. m o d i f i c a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 65 6 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S 14.13 1 4 . 1 3 PEMS P E M S intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K If I f the t h e PEMS P E M S is i s intended i n t e n d e d to t o be b e incorporated i n c o r p o r a t e d into i n t o an a n IT- I T - NETWORK N E T W O R K that t h a t is i s not n o t validated v a l i d a t e d by b y the t h e PEMS P E M S MANUFACTURER, M A N U F A C T U R E R , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l make m a k e available a v a i l a b l e instructions i n s t r u c t i o n s for f o r implementing i m p l e m e n t i n g such s u c h connection c o n n e c t i o n including i n c l u d i n g the t h e following f o l l o w i n g Requirements R e q u i r e m e n t s for f o r incorporation i n c o r p o r a t i o n into i n t o an a n IT-network I T - n e t w o r k are a r e not n o t included i n c l u d e d in i n this t h i s standard. s t a n d a r d . the t h e purpose p u r p o s e of o f the t h e PEMS’S P E M S ’ S connection c o n n e c t i o n to t o an a n IT- I T - NETWORK; N E T W O R K ; the t h e required r e q u i r e d characteristics c h a r a c t e r i s t i c s of o f the t h e IT-NETWORK I T - N E T W O R K incorporating i n c o r p o r a t i n g the t h e PEMS; P E M S ; the t h e required r e q u i r e d configuration c o n f i g u r a t i o n of o f the t h e IT-NETWORK I T - N E T W O R K incorporating i n c o r p o r a t i n g the t h e PEMS; P E M S ; the t h e technical t e c h n i c a l specifications s p e c i f i c a t i o n s of o f the t h e network n e t w o r k connection c o n n e c t i o n of o f the t h e PEMS P E M S including i n c l u d i n g security s e c u r i t y specifications; s p e c i f i c a t i o n s ; the t h e intended i n t e n d e d information i n f o r m a t i o n flow f l o w between b e t w e e n the t h e PEMS, P E M S , the t h e IT-NETWORK I T - N E T W O R K and a n d other o t h e r devices d e v i c e s on o n the t h e IT- I T - NETWORK, N E T W O R K , and a n d the t h e intended i n t e n d e d routing r o u t i n g through t h r o u g h the t h e IT- I T - NETWORK; N E T W O R K ; and a n d NOTE N O T E 1 1 This T h i s can c a n include i n c l u d e aspects a s p e c t s of o f effectiveness e f f e c t i v e n e s s and a n d data d a t a and a n d system s y s t e m security s e c u r i t y as a s related r e l a t e d to t o BASIC B A S I C SAFETY S A F E T Y and a n d ESSENTIAL E S S E N T I A L PERFORMANCE P E R F O R M A N C E (see ( s e e also a l s o Clause C l a u s e H.6 H . 6 and a n d IEC I E C 80001-1:2010). 8 0 0 0 1 - 1 : 2 0 1 0 ) . list l i s t the t h e HAZARDOUS H A Z A R D O U S SITUATIONS S I T U A T I O N S resulting r e s u l t i n g from f r o m a a failure f a i l u r e of o f the t h e IT-NETWORK I T - N E T W O R K to t o provide p r o v i d e the t h e characteristics c h a r a c t e r i s t i c s required r e q u i r e d to t o meet m e e t the t h e purpose p u r p o s e of o f the t h e PEMS P E M S connection c o n n e c t i o n to t o the t h e IT-NETWORK. I T - N E T W O R K . In I n the t h e ACCOMPANYING A C C O M P A N Y I N G DOCUMENTS, D O C U M E N T S , the t h e MANUFACTURER M A N U F A C T U R E R shall s h a l l instruct i n s t r u c t the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N that: t h a t : � connection c o n n e c t i o n of o f the t h e PEMS P E M S to t o an a n IT-NETWORK I T - N E T W O R K that t h a t includes i n c l u d e s other o t h e r equipment e q u i p m e n t could c o u l d result r e s u l t in i n previously p r e v i o u s l y unidentified u n i d e n t i f i e d RISKS R I S K S to t o PATIENTS, P A T I E N T S , OPERATORS O P E R A T O R S or o r third t h i r d parties; p a r t i e s ; � the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N should s h o u l d identify, i d e n t i f y , analyze, a n a l y z e , evaluate e v a l u a t e and a n d control c o n t r o l these t h e s e RISKS; R I S K S ; Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 66 6 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 PEMS P E M S requirements r e q u i r e m e n t s from f r o m IEC I E C 60601-1:2005 6 0 6 0 1 - 1 : 2 0 0 5 Requirements R e q u i r e m e n t s of o f IEC I E C 62304 6 2 3 0 4 relating r e l a t i n g to t o the t h e software s o f t w a r e subsystem s u b s y s t e m of o f a a PEMS P E M S NOTE N O T E 3 3 IEC I E C 80001-1:2010 8 0 0 0 1 - 1 : 2 0 1 0 provides p r o v i d e s guidance g u i d a n c e for f o r the t h e RESPONSIBLE R E S P O N S I B L E ORGANIZATION O R G A N I Z A T I O N to t o address a d d r e s s these t h e s e risks. r i s k s . � subsequent s u b s e q u e n t changes c h a n g e s to t o the t h e IT-NETWORK I T - N E T W O R K could c o u l d introduce i n t r o d u c e new n e w RISKS R I S K S and a n d require r e q u i r e additional a d d i t i o n a l analysis; a n a l y s i s ; and a n d � changes c h a n g e s to t o the t h e IT-NETWORK I T - N E T W O R K include: i n c l u d e : � changes c h a n g e s in i n the t h e IT-NETWORK I T - N E T W O R K configuration; c o n f i g u r a t i o n ; � connection c o n n e c t i o n of o f additional a d d i t i o n a l items i t e m s to t o the t h e IT- I T - NETWORK; N E T W O R K ; � disconnecting d i s c o n n e c t i n g items i t e m s from f r o m the t h e IT- I T - NETWORK; N E T W O R K ; � update u p d a t e of o f equipment e q u i p m e n t connected c o n n e c t e d to t o the t h e IT- I T - NETWORK; N E T W O R K ; � upgrade u p g r a d e of o f equipment e q u i p m e n t connected c o n n e c t e d to t o the t h e IT-NETWORK. I T - N E T W O R K . C.4.7 C . 4 . 7 Relationship R e l a t i o n s h i p to t o requirements r e q u i r e m e n t s in i n IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 IEC I E C 60601-1-4 6 0 6 0 1 - 1 - 4 has h a s been b e e n withdrawn. w i t h d r a w n . C.5 C . 5 Relationship R e l a t i o n s h i p to t o IEC I E C 61010-1 6 1 0 1 0 - 1 The T h e scope s c o p e of o f IEC I E C 61010-1 6 1 0 1 0 - 1 [5] [ 5 ] covers c o v e r s electrical e l e c t r i c a l test t e s t and a n d measuring m e a s u r i n g equipment, e q u i p m e n t , electrical e l e c t r i c a l control c o n t r o l equipment e q u i p m e n t and a n d electrical e l e c t r i c a l laboratory l a b o r a t o r y equipment. e q u i p m e n t . Only O n l y part p a r t of o f the t h e laboratory l a b o r a t o r y equipment e q u i p m e n t is i s used u s e d in i n a a medical m e d i c a l environment e n v i r o n m e n t or o r as a s in i n vitro v i t r o diagnostic d i a g n o s t i c equipment e q u i p m e n t (IVD). ( I V D ) . Due D u e to t o legal l e g a l regulations r e g u l a t i o n s or o r normative n o r m a t i v e references, r e f e r e n c e s , IVD I V D equipment e q u i p m e n t is i s allocated a l l o c a t e d to t o MEDICAL M E D I C A L DEVICES D E V I C E S without, w i t h o u t , however, h o w e v e r , falling f a l l i n g within w i t h i n the t h e scope s c o p e of o f IEC I E C 60601-1 6 0 6 0 1 - 1 [1]. [ 1 ] . This T h i s is i s attributable a t t r i b u t a b l e not n o t only o n l y to t o the t h e fact f a c t that, t h a t , strictly s t r i c t l y speaking, s p e a k i n g , IVD I V D instruments i n s t r u m e n t s are a r e not n o t MEDICAL M E D I C A L DEVICES D E V I C E S which w h i c h come c o m e into i n t o direct d i r e c t contact c o n t a c t with w i t h patients, p a t i e n t s , but b u t also a l s o to t o the t h e fact f a c t that t h a t such s u c h products p r o d u c t s are a r e manufactured m a n u f a c t u r e d for f o r many m a n y different d i f f e r e n t applications a p p l i c a t i o n s in i n various v a r i o u s laboratories. l a b o r a t o r i e s . Use U s e as a s an a n IVD I V D instrument i n s t r u m e n t or o r as a s an a n accessory a c c e s s o r y for f o r an a n IVD I V D instrument i n s t r u m e n t is i s then t h e n rare. r a r e . If I f laboratory l a b o r a t o r y equipment e q u i p m e n t is i s used u s e d as a s IVD I V D equipment, e q u i p m e n t , the t h e measured m e a s u r e d results r e s u l t s obtained o b t a i n e d must m u s t be b e EVALUATED E V A L U A T E D in i n accordance a c c o r d a n c e with w i t h medical m e d i c a l criteria. c r i t e r i a . The T h e application a p p l i c a t i o n of o f ISO I S O 14971 1 4 9 7 1 is i s required r e q u i r e d for f o r RISK R I S K MANAGEMENT. M A N A G E M E N T . If I f such s u c h products p r o d u c t s also a l s o contain c o n t a i n software s o f t w a r e that t h a t can c a n lead l e a d to t o a a HAZARDOUS H A Z A R D O U S SITUATION, S I T U A T I O N , for f o r example e x a m p l e failure f a i l u r e caused c a u s e d by b y the t h e software s o f t w a r e which w h i c h results r e s u l t s in i n an a n unwanted u n w a n t e d change c h a n g e of o f medical m e d i c a l data d a t a (measuring ( m e a s u r i n g results), r e s u l t s ) , IEC I E C 62304 6 2 3 0 4 must m u s t be b e taken t a k e n into i n t o account. a c c o u n t . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . IEC I E C 61010-1:2010 6 1 0 1 0 - 1 : 2 0 1 0 has h a s a a general g e n e r a l requirement r e q u i r e m e n t for f o r risk r i s k assessment a s s e s s m e n t in i n Clause C l a u s e 17, 1 7 , which w h i c h is i s more m o r e streamlined s t r e a m l i n e d than t h a n the t h e full f u l l risk r i s k management m a n a g e m e n t requirements r e q u i r e m e n t s of o f ISO I S O 14971. 1 4 9 7 1 . Applying A p p l y i n g IEC I E C 61010-1 6 1 0 1 0 - 1 Clause C l a u s e 17 1 7 alone a l o n e does d o e s not n o t meet m e e t the t h e required r e q u i r e d criteria c r i t e r i a for f o r risk r i s k management m a n a g e m e n t of o f IEC I E C 62304, 6 2 3 0 4 , which w h i c h is i s based b a s e d on o n full f u l l ISO I S O 14971 1 4 9 7 1 risk r i s k management m a n a g e m e n t requirements. r e q u i r e m e n t s . With W i t h this t h i s in i n mind, m i n d , it i t is i s expected e x p e c t e d by b y this t h i s standard s t a n d a r d that t h a t when w h e n an a n IVD I V D medical m e d i c a l device d e v i c e has h a s software-related s o f t w a r e - r e l a t e d risks, r i s k s , its i t s risk r i s k management m a n a g e m e n t process p r o c e s s is i s performed p e r f o r m e d following f o l l o w i n g ISO I S O 14971 1 4 9 7 1 instead i n s t e a d of o f only o n l y Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1. 6 1 0 1 0 - 1 . Compliance C o m p l i a n c e with w i t h Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1 6 1 0 1 0 - 1 will w i l l be b e achieved, a c h i e v e d , as a s detailed d e t a i l e d in i n the t h e Note N o t e to t o Clause C l a u s e 17 1 7 of o f IEC I E C 61010-1: 6 1 0 1 0 - 1 : NOTE N O T E One O n e RISK R I S K assessment a s s e s s m e n t procedure p r o c e d u r e is i s outlined o u t l i n e d in i n Annex A n n e x J. J . Other O t h e r RISK R I S K assessment a s s e s s m e n t procedures p r o c e d u r e s are a r e contained c o n t a i n e d in i n ISO I S O 14971, 1 4 9 7 1 , SEMI S E M I S10-1296, S 1 0 - 1 2 9 6 , IEC I E C 61508, 6 1 5 0 8 , ISO I S O 14121-1, 1 4 1 2 1 - 1 , and a n d ANSI A N S I B11.TR3. B 1 1 . T R 3 . Other O t h e r established e s t a b l i s h e d procedures p r o c e d u r e s which w h i c h implement i m p l e m e n t similar s i m i l a r steps s t e p s can c a n also a l s o be b e used. u s e d . The T h e flowchart f l o w c h a r t in i n Figure F i g u r e C.3 C . 3 shows s h o w s the t h e application a p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1, 6 1 0 1 0 - 1 , Clause C l a u s e 17: 1 7 : granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 67 6 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Intended I n t e n d e d purpose p u r p o s e and a n d use u s e defined d e f i n e d Possible P o s s i b l e sources s o u r c e s of o f HAZARD H A Z A R D identified i d e n t i f i e d Identify I d e n t i f y known k n o w n and a n d reasonably r e a s o n a b l y foreseeable f o r e s e e a b l e HAZARDS H A Z A R D S Is I s the t h e HAZARD H A Z A R D covered c o v e r e d by b y relevant r e l e v a n t safety s a f e t y standards? s t a n d a r d s ? Yes Y e s No N o Use U s e ISO I S O 14971 1 4 9 7 1 for f o r RISK R I S K MANAGEMENT M A N A G E M E N T Yes Y e s Does D o e s the t h e device d e v i c e No N o provide p r o v i d e medical m e d i c a l relevant r e l e v a n t data d a t a Does D o e s the t h e software s o f t w a r e have h a v e any a n y impact i m p a c t on o n the t h e medical m e d i c a l data? d a t a ? No N o Yes Y e s Use U s e of o f procedures p r o c e d u r e s required r e q u i r e d to t o verify v e r i f y the t h e data? d a t a ? Yes Y e s No N o HAZARD H A Z A R D related r e l a t e d to t o the t h e handling h a n d l i n g of o f medical m e d i c a l data d a t a Verify V e r i f y according a c c o r d i n g to t o the t h e relevant r e l e v a n t safety s a f e t y standard s t a n d a r d Select S e l e c t an a n applicable a p p l i c a b l e method m e t h o d for f o r RISK R I S K CONTROL C O N T R O L based b a s e d on o n safety s a f e t y standard s t a n d a r d Additional A d d i t i o n a l requirements r e q u i r e m e n t s necessary n e c e s s a r y to t o ensure e n s u r e that t h a t wrong w r o n g data d a t a are a r e detected d e t e c t e d prior p r i o r to t o use u s e of o f data d a t a for f o r medical m e d i c a l purposes. p u r p o s e s . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . Use U s e IEC I E C 62304 6 2 3 0 4 IEC I E C 727/06 7 2 7 / 0 6 Figure F i g u r e C.3 C . 3 – – Application A p p l i c a t i o n of o f IEC I E C 62304 6 2 3 0 4 with w i t h IEC I E C 61010-1 6 1 0 1 0 - 1 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 68 6 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 C.6 C . 6 Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207 1 2 2 0 7 This T h i s standard s t a n d a r d has h a s been b e e n derived d e r i v e d from f r o m the t h e approach a p p r o a c h and a n d concepts c o n c e p t s of o f ISO/IEC I S O / I E C 12207 1 2 2 0 7 [9], [ 9 ] , which w h i c h defines d e f i n e s requirements r e q u i r e m e n t s for f o r software s o f t w a r e life l i f e cycle c y c l e PROCESSES P R O C E S S E S in i n general, g e n e r a l , i.e. i . e . not n o t restricted r e s t r i c t e d to t o MEDICAL M E D I C A L DEVICES. D E V I C E S . This T h i s standard s t a n d a r d differs d i f f e r s from f r o m ISO/IEC I S O / I E C 12207 1 2 2 0 7 mainly m a i n l y with w i t h respect r e s p e c t to t o the t h e following. f o l l o w i n g . It: I t : � excludes e x c l u d e s SYSTEM S Y S T E M aspects, a s p e c t s , such s u c h as a s SYSTEM S Y S T E M requirements, r e q u i r e m e n t s , SYSTEM S Y S T E M ARCHITECTURE A R C H I T E C T U R E and a n d validation; v a l i d a t i o n ; � omits o m i t s some s o m e PROCESSES P R O C E S S E S seen s e e n as a s duplicating d u p l i c a t i n g ACTIVITIES A C T I V I T I E S documented d o c u m e n t e d elsewhere e l s e w h e r e for f o r MEDICAL M E D I C A L DEVICES; D E V I C E S ; � adds a d d s the t h e (SAFETY) ( S A F E T Y ) RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S and a n d the t h e software s o f t w a r e release r e l e a s e PROCESS; P R O C E S S ; � incorporates i n c o r p o r a t e s the t h e documentation d o c u m e n t a t i o n and a n d the t h e VERIFICATION V E R I F I C A T I O N supporting s u p p o r t i n g PROCESSES P R O C E S S E S into i n t o the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e PROCESSES; P R O C E S S E S ; � merges m e r g e s the t h e PROCESS P R O C E S S implementation i m p l e m e n t a t i o n and a n d planning p l a n n i n g ACTIVITIES A C T I V I T I E S of o f each e a c h PROCESS P R O C E S S into i n t o a a single s i n g l e ACTIVITY A C T I V I T Y in i n the t h e development d e v e l o p m e n t and a n d maintenance m a i n t e n a n c e PROCESSES; P R O C E S S E S ; � classifies c l a s s i f i e s the t h e requirements r e q u i r e m e n t s with w i t h respect r e s p e c t to t o SAFETY S A F E T Y needs; n e e d s ; and a n d � does d o e s not n o t explicitly e x p l i c i t l y classify c l a s s i f y PROCESSES P R O C E S S E S as a s primary p r i m a r y or o r supporting, s u p p o r t i n g , nor n o r group g r o u p PROCESSES P R O C E S S E S as a s ISO/IEC I S O / I E C 12207 1 2 2 0 7 does. d o e s . Most M o s t of o f these t h e s e changes c h a n g e s were w e r e driven d r i v e n by b y the t h e desire d e s i r e to t o tailor t a i l o r the t h e standard s t a n d a r d to t o the t h e need n e e d of o f the t h e MEDICAL M E D I C A L DEVICE D E V I C E sector s e c t o r by: b y : � focusing f o c u s i n g on o n SAFETY S A F E T Y aspects a s p e c t s and a n d the t h e MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K MANAGEMENT M A N A G E M E N T standard s t a n d a r d ISO I S O 14971; 1 4 9 7 1 ; � selecting s e l e c t i n g the t h e appropriate a p p r o p r i a t e PROCESSES P R O C E S S E S useful u s e f u l in i n a a regulated r e g u l a t e d environment; e n v i r o n m e n t ; taking t a k i n g into i n t o account a c c o u n t that t h a t software s o f t w a r e development d e v e l o p m e n t is i s embedded e m b e d d e d in i n a a quality q u a l i t y system s y s t e m (which ( w h i c h covers c o v e r s some s o m e of o f the t h e PROCESSES P R O C E S S E S and a n d requirements r e q u i r e m e n t s of o f ISO/IEC I S O / I E C 12207); 1 2 2 0 7 ) ; and a n d lowering l o w e r i n g the t h e level l e v e l of o f abstraction a b s t r a c t i o n to t o make m a k e it i t easier e a s i e r to t o use. u s e . This T h i s standard s t a n d a r d is i s not n o t contradictory c o n t r a d i c t o r y to t o ISO/IEC I S O / I E C 12207. 1 2 2 0 7 . ISO/IEC I S O / I E C 12207 1 2 2 0 7 can c a n be b e useful u s e f u l as a s an a n aide a i d e in i n setting s e t t i n g up u p a a well w e l l structured s t r u c t u r e d SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL M O D E L that t h a t includes i n c l u d e s the t h e requirements r e q u i r e m e n t s of o f this t h i s standard. s t a n d a r d . Table T a b l e C.5, C . 5 , which w h i c h was w a s prepared p r e p a r e d by b y ISO/IEC I S O / I E C JTC1/SC7, J T C 1 / S C 7 , shows s h o w s the t h e relationship r e l a t i o n s h i p between b e t w e e n IEC I E C 62304 6 2 3 0 4 and a n d ISO/IEC I S O / I E C 12207. 1 2 2 0 7 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 69 6 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e C.5 C . 5 – – Relationship R e l a t i o n s h i p to t o ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5 5 Software S o f t w a r e development d e v e l o p m e n t PROCESS P R O C E S S 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 5.1.1 5 . 1 . 1 Software S o f t w a r e development d e v e l o p m e n t plan p l a n 7.1.1 7 . 1 . 1 Software S o f t w a r e Implementation I m p l e m e n t a t i o n 7.1.1.3.1 7 . 1 . 1 . 3 . 1 Software S o f t w a r e implementation i m p l e m e n t a t i o n strategy s t r a t e g y 7.1.1.3.1.1 7 . 1 . 1 . 3 . 1 . 1 7.1.1.3.1.3 7 . 1 . 1 . 3 . 1 . 3 7.1.1.3.1.4 7 . 1 . 1 . 3 . 1 . 4 6.3.1.3.2 6 . 3 . 1 . 3 . 2 Project P r o j e c t planning p l a n n i n g 6.3.1.3.2.1 6 . 3 . 1 . 3 . 2 . 1 5.1.2 5 . 1 . 2 Keep K e e p software s o f t w a r e development d e v e l o p m e n t plan p l a n updated u p d a t e d 6.3.2 6 . 3 . 2 Project P r o j e c t Assesment A s s e s m e n t and a n d Control C o n t r o l 6.3.2.3.2 6 . 3 . 2 . 3 . 2 Project P r o j e c t control c o n t r o l 6.3.2.3.2.1 6 . 3 . 2 . 3 . 2 . 1 5.1.3 5 . 1 . 3 Software S o f t w a r e development d e v e l o p m e n t plan p l a n reference r e f e r e n c e to t o SYSTEM S Y S T E M design d e s i g n and a n d development d e v e l o p m e n t 6.4.3 6 . 4 . 3 System S y s t e m Architectural A r c h i t e c t u r a l Design D e s i g n 6.4.5 6 . 4 . 5 System S y s t e m Integration I n t e g r a t i o n 7.2.5 7 . 2 . 5 Software S o f t w a r e Validation V a l i d a t i o n Process P r o c e s s 6.4.3.3.1 6 . 4 . 3 . 3 . 1 Establishing E s t a b l i s h i n g architecture a r c h i t e c t u r e 6.4.3.3.1.1 6 . 4 . 3 . 3 . 1 . 1 6.4.5.3.1 6 . 4 . 5 . 3 . 1 Integration I n t e g r a t i o n 6.4.5.3.1.1 6 . 4 . 5 . 3 . 1 . 1 7.2.5.3.1 7 . 2 . 5 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.5.3.1.4 7 . 2 . 5 . 3 . 1 . 4 5.1.4 5 . 1 . 4 Software S o f t w a r e development d e v e l o p m e n t standards, s t a n d a r d s , methods m e t h o d s and a n d tools t o o l s planning p l a n n i n g 7.1.1 7 . 1 . 1 Software S o f t w a r e Implementation I m p l e m e n t a t i o n 7.1.1.3.1 7 . 1 . 1 . 3 . 1 Software S o f t w a r e implementation i m p l e m e n t a t i o n strategy s t r a t e g y 7.1.1.3.1.3 7 . 1 . 1 . 3 . 1 . 3 5.1.5 5 . 1 . 5 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g planning p l a n n i n g 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.1 7 . 1 . 6 . 3 . 1 . 1 5.1.6 5 . 1 . 6 Software S o f t w a r e VERIFICATION V E R I F I C A T I O N planning p l a n n i n g 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.4 7 . 2 . 4 . 3 . 1 . 4 7.2.4.3.1.5 7 . 2 . 4 . 3 . 1 . 5 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e constrution c o n s t r u t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.5 7 . 1 . 6 . 3 . 1 . 5 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.1.7 5 . 1 . 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T planning p l a n n i n g 6.3.4 6 . 3 . 4 Risk R i s k Management M a n a g e m e n t Process P r o c e s s 5.1.8 5 . 1 . 8 Documentation D o c u m e n t a t i o n planning p l a n n i n g 7.2.1 7 . 2 . 1 Software S o f t w a r e Documentation D o c u m e n t a t i o n Management M a n a g e m e n t 7.2.1.3.1 7 . 2 . 1 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.1.3.1.1 7 . 2 . 1 . 3 . 1 . 1 5.1.9 5 . 1 . 9 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t planning p l a n n i n g 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.2.3.1 7 . 2 . 2 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.2.3.1.1 7 . 2 . 2 . 3 . 1 . 1 7.2.8.3.1 7 . 2 . 8 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.8.3.1.1 7 . 2 . 8 . 3 . 1 . 1 5.1.10 5 . 1 . 1 0 Supporting S u p p o r t i n g items i t e m s to t o be b e controlled c o n t r o l l e d 6.2.2 6 . 2 . 2 Infrastructure I n f r a s t r u c t u r e Management M a n a g e m e n t 6.2.2 6 . 2 . 2 Infrastructure I n f r a s t r u c t u r e Management M a n a g e m e n t 6.2.2.3.2 6 . 2 . 2 . 3 . 2 Establishment E s t a b l i s h m e n t of o f the t h e infrastructure i n f r a s t r u c t u r e 6.2.2.3.2.1 6 . 2 . 2 . 3 . 2 . 1 6.2.2.3.3 6 . 2 . 2 . 3 . 3 Maintenance M a i n t e n a n c e of o f the t h e infrastructure i n f r a s t r u c t u r e 6.2.2.3.3.1 6 . 2 . 2 . 3 . 3 . 1 5.1.11 5 . 1 . 1 1 Software S o f t w a r e CONFIGURATION C O N F I G U R A T I O N ITEM I T E M control c o n t r o l before b e f o r e VERIFICATION V E R I F I C A T I O N 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.2.2.3.2 7 . 2 . 2 . 3 . 2 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.2.2.3.2.1 7 . 2 . 2 . 3 . 2 . 1 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 70 7 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 5.2.1 5 . 2 . 1 Define D e f i n e and a n d document d o c u m e n t software s o f t w a r e requirements r e q u i r e m e n t s from f r o m SYSTEM S Y S T E M requirements r e q u i r e m e n t s 6.4.3 6 . 4 . 3 System S y s t e m Architectural A r c h i t e c t u r a l Design D e s i g n 6.4.3.3.1 6 . 4 . 3 . 3 . 1 Establishing E s t a b l i s h i n g architecture a r c h i t e c t u r e 6.4.3.3.1.1 6 . 4 . 3 . 3 . 1 . 1 5.2.2 5 . 2 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s content c o n t e n t 7.1.2 7 . 1 . 2 Software S o f t w a r e Requirements R e q u i r e m e n t s Analysis A n a l y s i s 7.1.2.3.1 7 . 1 . 2 . 3 . 1 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.1.2.3.1.1 7 . 1 . 2 . 3 . 1 . 1 5.2.3 5 . 2 . 3 Include I n c l u d e RISK R I S K CONTROL C O N T R O L measures m e a s u r e s in i n software s o f t w a r e requirements r e q u i r e m e n t s 5.2.4 5 . 2 . 4 Re-EVALUATE R e - E V A L U A T E MEDICAL M E D I C A L DEVICE D E V I C E RISK R I S K ANALYSIS A N A L Y S I S None N o n e None N o n e 5.2.5 5 . 2 . 5 Update U p d a t e SYSTEM S Y S T E M requirements r e q u i r e m e n t s 7.1.2 7 . 1 . 2 Software S o f t w a r e Requirements R e q u i r e m e n t s Analysis A n a l y s i s 7.1.2.3.1 7 . 1 . 2 . 3 . 1 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.1.2.3.1.1 7 . 1 . 2 . 3 . 1 . 1 a) a ) & & b) b ) 5.2.6 5 . 2 . 6 Verify V e r i f y software s o f t w a r e requirements r e q u i r e m e n t s 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.2 7 . 2 . 4 . 3 . 2 Verification V e r i f i c a t i o n 7.2.4.3.2.1 7 . 2 . 4 . 3 . 2 . 1 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n 5.3.1 5 . 3 . 1 Transform T r a n s f o r m software s o f t w a r e requirements r e q u i r e m e n t s into i n t o an a n ARCHITECTURE A R C H I T E C T U R E 7.1.3 7 . 1 . 3 Software S o f t w a r e Architectural A r c h i t e c t u r a l Design D e s i g n 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.1 7 . 1 . 3 . 3 . 1 . 1 5.3.2 5 . 3 . 2 Develop D e v e l o p an a n ARCHITECTURE A R C H I T E C T U R E for f o r the t h e interfaces i n t e r f a c e s of o f SOFTWARE S O F T W A R E ITEMS I T E M S 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.2 7 . 1 . 3 . 3 . 1 . 2 5.3.3 5 . 3 . 3 Specify S p e c i f y functional f u n c t i o n a l and a n d performance p e r f o r m a n c e requirements r e q u i r e m e n t s of o f SOUP S O U P item i t e m None N o n e none n o n e 5.3.4 5 . 3 . 4 Specify S p e c i f y SYSTEM S Y S T E M hardware h a r d w a r e and a n d software s o f t w a r e required r e q u i r e d by b y SOUP S O U P item i t e m None N o n e none n o n e 5.3.5 5 . 3 . 5 Identify I d e n t i f y segregation s e g r e g a t i o n necessary n e c e s s a r y for f o r RISK R I S K CONTROL C O N T R O L None N o n e none n o n e 5.3.6 5 . 3 . 6 Verify V e r i f y software s o f t w a r e ARCHITECTURE A R C H I T E C T U R E 7.1.3 7 . 1 . 3 Software S o f t w a r e Architectural A r c h i t e c t u r a l Design D e s i g n 7.1.3.3.1 7 . 1 . 3 . 3 . 1 Software S o f t w a r e architectural a r c h i t e c t u r a l design d e s i g n 7.1.3.3.1.6 7 . 1 . 3 . 3 . 1 . 6 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 5.4.1 5 . 4 . 1 Refine R e f i n e SOFTWARE S O F T W A R E ARCHITECTURE A R C H I T E C T U R E into i n t o SOFTWARE S O F T W A R E UNITS U N I T S 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.1 7 . 1 . 4 . 3 . 1 . 1 5.4.2 5 . 4 . 2 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r each e a c h SOFTWARE S O F T W A R E UNIT U N I T 5.4.3 5 . 4 . 3 Develop D e v e l o p detailed d e t a i l e d design d e s i g n for f o r interfaces i n t e r f a c e s 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.2 7 . 1 . 4 . 3 . 1 . 2 5.4.4 5 . 4 . 4 Verify V e r i f y detailed d e t a i l e d design d e s i g n 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.7 7 . 1 . 4 . 3 . 1 . 7 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n 5.5.1 5 . 5 . 1 Implement I m p l e m e n t each e a c h SOFTWARE S O F T W A R E UNIT U N I T 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.1 7 . 1 . 5 . 3 . 1 . 1 5.5.2 5 . 5 . 2 Establish E s t a b l i s h SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N PROCESS P R O C E S S 7.1.4 7 . 1 . 4 Software S o f t w a r e Detailed D e t a i l e d Design D e s i g n 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.4.3.1 7 . 1 . 4 . 3 . 1 Software S o f t w a r e detailed d e t a i l e d design d e s i g n 7.1.4.3.1.5 7 . 1 . 4 . 3 . 1 . 5 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 5.5.3 5 . 5 . 3 SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.5 7 . 1 . 5 . 3 . 1 . 5 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 71 7 1 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.5.4 5 . 5 . 4 Additional A d d i t i o n a l SOFTWARE S O F T W A R E UNIT U N I T acceptance a c c e p t a n c e criteria c r i t e r i a 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.2 7 . 1 . 5 . 3 . 1 . 2 5.5.5 5 . 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T VERIFICATION V E R I F I C A T I O N 7.1.5 7 . 1 . 5 Software S o f t w a r e Construction C o n s t r u c t i o n 7.1.5.3.1 7 . 1 . 5 . 3 . 1 Software S o f t w a r e construction c o n s t r u c t i o n 7.1.5.3.1.2 7 . 1 . 5 . 3 . 1 . 2 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g 5.6.1 5 . 6 . 1 Integrate I n t e g r a t e SOFTWARE S O F T W A R E UNITS U N I T S 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.2 5 . 6 . 2 Verify V e r i f y software s o f t w a r e integration i n t e g r a t i o n 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 6.4.5 6 . 4 . 5 System S y s t e m Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 6.4.5.3.1 6 . 4 . 5 . 3 . 1 Integration I n t e g r a t i o n 6.4.5.3.1.2 6 . 4 . 5 . 3 . 1 . 2 5.6.3 5 . 6 . 3 Test T e s t integrated i n t e g r a t e d software s o f t w a r e 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.6.4 5 . 6 . 4 Integration I n t e g r a t i o n testing t e s t i n g content c o n t e n t 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.6.5 5 . 6 . 5 Verify V e r i f y integration i n t e g r a t i o n tests t e s t s procedures p r o c e d u r e s None N o n e None N o n e 5.6.6 5 . 6 . 6 Conduct C o n d u c t regression r e g r e s s i o n tests t e s t s 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.7 5 . 6 . 7 Integration I n t e g r a t i o n test t e s t record r e c o r d contents c o n t e n t s 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.2 7 . 1 . 6 . 3 . 1 . 2 5.6.8 5 . 6 . 8 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.6 7 . 2 . 4 . 3 . 1 . 6 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 5.7.1 5 . 7 . 1 Establish E s t a b l i s h tests t e s t s for f o r each e a c h software s o f t w a r e requirement r e q u i r e m e n t 7.1.6 7 . 1 . 6 Software S o f t w a r e Integration I n t e g r a t i o n 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.6.3.1 7 . 1 . 6 . 3 . 1 Software S o f t w a r e integration i n t e g r a t i o n 7.1.6.3.1.4 7 . 1 . 6 . 3 . 1 . 4 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.7.2 5 . 7 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 7.2.4 7 . 2 . 4 Software S o f t w a r e Verification V e r i f i c a t i o n 7.2.4.3.1 7 . 2 . 4 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.4.3.1.6 7 . 2 . 4 . 3 . 1 . 6 5.7.3 5 . 7 . 3 Retest R e t e s t after a f t e r changes c h a n g e s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8.3.1 7 . 2 . 8 . 3 . 1 Process P r o c e s s implementation i m p l e m e n t a t i o n 7.2.8.3.1.1 7 . 2 . 8 . 3 . 1 . 1 5.7.4 5 . 7 . 4 Verify V e r i f y SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.7.5 5 . 7 . 5 SOFTWARE S O F T W A R E SYSTEM S Y S T E M test t e s t record r e c o r d contents c o n t e n t s 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.1 7 . 1 . 7 . 3 . 1 . 1 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 5.8.1 5 . 8 . 1 Ensure E n s u r e software s o f t w a r e VERIFICATION V E R I F I C A T I O N is i s complete c o m p l e t e 6.4.9 6 . 4 . 9 Software S o f t w a r e Operation O p e r a t i o n 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 6.4.9.3.2 6 . 4 . 9 . 3 . 2 Operation O p e r a t i o n activation a c t i v a t i o n and a n d check-out c h e c k - o u t 6.4.9.3.2.1 6 . 4 . 9 . 3 . 2 . 1 6.4.9.3.2.2 6 . 4 . 9 . 3 . 2 . 2 7.2.2.3.6 7 . 2 . 2 . 3 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 7.2.2.3.6.1 7 . 2 . 2 . 3 . 6 . 1 5.8.2 5 . 8 . 2 Document D o c u m e n t known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 7.1.7 7 . 1 . 7 Software S o f t w a r e Qualification Q u a l i f i c a t i o n Testing T e s t i n g 7.2.2.3.5 7 . 2 . 2 . 3 . 5 Configuration C o n f i g u r a t i o n evaluation e v a l u a t i o n 7.2.2.3.5.1 7 . 2 . 2 . 3 . 5 . 1 7.1.7.3.1 7 . 1 . 7 . 3 . 1 Software S o f t w a r e qualification q u a l i f i c a t i o n testing t e s t i n g 7.1.7.3.1.3 7 . 1 . 7 . 3 . 1 . 3 5.8.3 5 . 8 . 3 EVALUATE E V A L U A T E known k n o w n residual r e s i d u a l ANOMALIES A N O M A L I E S Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 72 7 2 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 5.8.4 5 . 8 . 4 Document D o c u m e n t released r e l e a s e d VERSIONS V E R S I O N S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t Process P r o c e s s 7.2.2.3.6 7 . 2 . 2 . 3 . 6 Release R e l e a s e management m a n a g e m e n t and a n d delivery d e l i v e r y 7.2.2.3.6.1 7 . 2 . 2 . 3 . 6 . 1 5.8.5 5 . 8 . 5 Document D o c u m e n t how h o w released r e l e a s e d software s o f t w a r e was w a s created c r e a t e d 5.8.6 5 . 8 . 6 Ensure E n s u r e ACTIVITIES A C T I V I T I E S and a n d TASKS T A S K S are a r e complete c o m p l e t e 5.8.7 5 . 8 . 7 Archive A r c h i v e software s o f t w a r e 5.8.8 5 . 8 . 8 Assure A s s u r e repeatability r e p e a t a b i l i t y of o f software s o f t w a r e release r e l e a s e 6 6 Software S o f t w a r e maintenance m a i n t e n a n c e PROCESS P R O C E S S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e Process P r o c e s s 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s 6.2.1 6 . 2 . 1 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k None N o n e None N o n e 6.2.1.1 6 . 2 . 1 . 1 Monitor M o n i t o r feedback f e e d b a c k 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.1.2 6 . 2 . 1 . 2 Document D o c u m e n t and a n d EVALUATE E V A L U A T E feedback f e e d b a c k 6.2.1.3 6 . 2 . 1 . 3 EVALUATE E V A L U A T E PROBLEM P R O B L E M REPORT’S R E P O R T ’ S effects e f f e c t s on o n SAFETY S A F E T Y 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.2 6 . 2 . 2 Use U s e software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.3 6 . 2 . 3 Analyse A n a l y s e CHANGE C H A N G E REQUESTS R E Q U E S T S 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.4 6 . 2 . 4 CHANGE C H A N G E REQUEST R E Q U E S T approval a p p r o v a l 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.2.5 6 . 2 . 5 Communicate C o m m u n i c a t e to t o users u s e r s and a n d regulators r e g u l a t o r s 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n None N o n e None N o n e 6.3.1 6 . 3 . 1 Use U s e established e s t a b l i s h e d PROCESS P R O C E S S to t o implement i m p l e m e n t modification m o d i f i c a t i o n 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 6.3.2 6 . 3 . 2 Re-release R e - r e l e a s e modified m o d i f i e d SOFTWARE S O F T W A R E SYSTEM S Y S T E M 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 7 7 Software S o f t w a r e RISK R I S K MANAGEMENT M A N A G E M E N T PROCESS P R O C E S S 6.3.4 6 . 3 . 4 Risk R i s k Management M a n a g e m e n t Process P r o c e s s This T h i s is i s based b a s e d on o n ISO/IEC I S O / I E C 16085. 1 6 0 8 5 . While W h i l e there t h e r e is i s some s o m e commonality c o m m o n a l i t y it i t does d o e s not n o t address a d d r e s s the t h e specific s p e c i f i c requirements r e q u i r e m e n t s for f o r medical m e d i c a l device d e v i c e software s o f t w a r e development d e v e l o p m e n t with w i t h regard r e g a r d to t o risk r i s k management m a n a g e m e n t 8 8 Software S o f t w a r e configuration c o n f i g u r a t i o n management m a n a g e m e n t PROCESS P R O C E S S 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 8.1.1 8 . 1 . 1 Establish E s t a b l i s h means m e a n s to t o identify i d e n t i f y CONFIGURATION C O N F I G U R A T I O N ITEMS I T E M S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 8.1.2 8 . 1 . 2 Identify I d e n t i f y SOUP S O U P None N o n e None N o n e 8.1.3 8 . 1 . 3 Identify I d e n t i f y SYSTEM S Y S T E M configuration c o n f i g u r a t i o n documentation d o c u m e n t a t i o n 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 8.2 8 . 2 Change C h a n g e control c o n t r o l 8.2.1 8 . 2 . 1 Approve A p p r o v e CHANGE C H A N G E REQUESTS R E Q U E S T S 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 8.2.2 8 . 2 . 2 Implement I m p l e m e n t changes c h a n g e s 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e None N o n e 8.2.3 8 . 2 . 3 Verify V e r i f y changes c h a n g e s 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t None N o n e 8.2.4 8 . 2 . 4 Provide P r o v i d e means m e a n s for f o r TRACEABILITY T R A C E A B I L I T Y of o f change c h a n g e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 73 7 3 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 ISO/IEC I S O / I E C 62304 6 2 3 0 4 PROCESSES P R O C E S S E S ISO/IEC I S O / I E C 12207:2008 1 2 2 0 7 : 2 0 0 8 ACTIVITY A C T I V I T Y TASK T A S K PROCESSES P R O C E S S E S ACTIVITY/TASK A C T I V I T Y / T A S K 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t Non N o n e e 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S 9.1 9 . 1 Prepare P r e p a r e PROBLEM P R O B L E M REPORTS R E P O R T S 9.2 9 . 2 Investigate I n v e s t i g a t e the t h e problem p r o b l e m 9.3 9 . 3 Advise A d v i s e relevant r e l e v a n t parties p a r t i e s 9.4 9 . 4 Use U s e change c h a n g e control c o n t r o l process p r o c e s s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.2 7 . 2 . 2 Software S o f t w a r e Configuration C o n f i g u r a t i o n Management M a n a g e m e n t 6.4.10 6 . 4 . 1 0 Software S o f t w a r e Maintenance M a i n t e n a n c e 9.5 9 . 5 Maintain M a i n t a i n records r e c o r d s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 9.6 9 . 6 Analyse A n a l y s e problems p r o b l e m s for f o r trends t r e n d s 9.7 9 . 7 Verify V e r i f y software s o f t w a r e problem p r o b l e m resolution r e s o l u t i o n 9.8 9 . 8 Test T e s t documentation d o c u m e n t a t i o n contents c o n t e n t s 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n 7.2.8 7 . 2 . 8 Software S o f t w a r e Problem P r o b l e m Resolution R e s o l u t i o n All A l l testing t e s t i n g TASKS T A S K S in i n ISO I S O 12207 1 2 2 0 7 require r e q u i r e documentation d o c u m e n t a t i o n None N o n e None N o n e None N o n e None N o n e None N o n e None N o n e None N o n e None N o n e C.7 C . 7 Relationship R e l a t i o n s h i p to t o IEC I E C 61508 6 1 5 0 8 The T h e question q u e s t i o n has h a s been b e e n raised r a i s e d whether w h e t h e r this t h i s standard, s t a n d a r d , being b e i n g concerned c o n c e r n e d with w i t h the t h e design d e s i g n of o f SAFETY-critical S A F E T Y - c r i t i c a l software, s o f t w a r e , should s h o u l d follow f o l l o w the t h e principles p r i n c i p l e s of o f IEC I E C 61508. 6 1 5 0 8 . The T h e approach a p p r o a c h to t o safety s a f e t y in i n IEC I E C 62304 6 2 3 0 4 is i s fundamentally f u n d a m e n t a l l y different d i f f e r e n t than t h a n the t h e one o n e in i n IEC I E C 61508. 6 1 5 0 8 . IEC I E C 62304 6 2 3 0 4 takes t a k e s into i n t o account a c c o u n t that t h a t the t h e effectiveness e f f e c t i v e n e s s of o f medical m e d i c a l devices d e v i c e s justifies j u s t i f i e s residual r e s i d u a l risks r i s k s related r e l a t e d to t o their t h e i r use. u s e . The T h e following f o l l o w i n g explains e x p l a i n s the t h e stance s t a n c e of o f this t h i s standard. s t a n d a r d . IEC I E C 61508 6 1 5 0 8 addresses a d d r e s s e s 3 3 main m a i n issues: i s s u e s : RISK R I S K MANAGEMENT M A N A G E M E N T life l i f e cycle c y c l e and a n d life l i f e cycle c y c l e PROCESSES; P R O C E S S E S ; definition d e f i n i t i o n of o f Safety S a f e t y Integrity I n t e g r i t y Levels; L e v e l s ; recommendation r e c o m m e n d a t i o n of o f techniques, t e c h n i q u e s , tools t o o l s and a n d methods m e t h o d s for f o r software s o f t w a r e development d e v e l o p m e n t and a n d levels l e v e l s of o f independence i n d e p e n d e n c e of o f personnel p e r s o n n e l responsible r e s p o n s i b l e for f o r performing p e r f o r m i n g different d i f f e r e n t TASKS. T A S K S . Issue I s s u e 1) 1 ) is i s covered c o v e r e d in i n this t h i s standard s t a n d a r d by b y a a normative n o r m a t i v e reference r e f e r e n c e to t o ISO I S O 14971 1 4 9 7 1 (the ( t h e MEDICAL M E D I C A L DEVICE D E V I C E sector s e c t o r standard s t a n d a r d for f o r RISK R I S K MANAGEMENT). M A N A G E M E N T ) . The T h e effect e f f e c t of o f this t h i s reference r e f e r e n c e is i s to t o adopt a d o p t ISO I S O 14971’s 1 4 9 7 1 ’ s approach a p p r o a c h to t o RISK R I S K MANAGEMENT M A N A G E M E N T as a s an a n integral i n t e g r a l part p a r t of o f the t h e software s o f t w a r e PROCESS P R O C E S S for f o r MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE. S O F T W A R E . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . For F o r issue i s s u e 2), 2 ) , this t h i s standard s t a n d a r d takes t a k e s a a simpler s i m p l e r approach a p p r o a c h than t h a n IEC I E C 61508. 6 1 5 0 8 . The T h e latter l a t t e r classifies c l a s s i f i e s software s o f t w a r e into i n t o 4 4 “Safety “ S a f e t y Integrity I n t e g r i t y Levels” L e v e l s ” defined d e f i n e d in i n terms t e r m s of o f reliability r e l i a b i l i t y objectives. o b j e c t i v e s . The T h e reliability r e l i a b i l i t y objectives o b j e c t i v e s are a r e identified i d e n t i f i e d after a f t e r RISK R I S K ANALYSIS, A N A L Y S I S , which w h i c h quantifies q u a n t i f i e s both b o t h the t h e severity s e v e r i t y and a n d the t h e probability p r o b a b i l i t y of o f HARM H A R M caused c a u s e d by b y a a failure f a i l u r e of o f the t h e software. s o f t w a r e . This T h i s standard s t a n d a r d simplifies s i m p l i f i e s issue i s s u e 2) 2 ) by b y defining d e f i n i n g the t h e classification c l a s s i f i c a t i o n into i n t o 3 3 software s o f t w a r e safety s a f e t y classes c l a s s e s based b a s e d on o n the t h e RISK R I S K caused c a u s e d by b y a a failure. f a i l u r e . After A f t e r classification, c l a s s i f i c a t i o n , different d i f f e r e n t PROCESSES P R O C E S S E S are a r e required r e q u i r e d for f o r different d i f f e r e n t software s o f t w a r e safety s a f e t y classes: c l a s s e s : the t h e intention i n t e n t i o n is i s to t o further f u r t h e r reduce r e d u c e the t h e probability p r o b a b i l i t y (and/or ( a n d / o r the t h e severity) s e v e r i t y ) of o f failure f a i l u r e of o f the t h e software. s o f t w a r e . Issue I s s u e 3) 3 ) is i s not n o t addressed a d d r e s s e d by b y this t h i s standard. s t a n d a r d . Readers R e a d e r s of o f the t h e standard s t a n d a r d are a r e encouraged e n c o u r a g e d to t o use u s e IEC I E C 61508 6 1 5 0 8 as a s a a source s o u r c e for f o r good g o o d software s o f t w a r e methods, m e t h o d s , techniques t e c h n i q u e s and a n d tools, t o o l s , while w h i l e recognising r e c o g n i s i n g granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 74 7 4 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 that t h a t other o t h e r approaches, a p p r o a c h e s , both b o t h present p r e s e n t and a n d future, f u t u r e , can c a n provide p r o v i d e equally e q u a l l y good g o o d results. r e s u l t s . This T h i s standard s t a n d a r d makes m a k e s no n o recommendation r e c o m m e n d a t i o n concerning c o n c e r n i n g independence i n d e p e n d e n c e of o f people p e o p l e responsible r e s p o n s i b l e for f o r one o n e software s o f t w a r e ACTIVITY A C T I V I T Y (for ( f o r example e x a m p l e VERIFICATION) V E R I F I C A T I O N ) from f r o m those t h o s e responsible r e s p o n s i b l e for f o r another a n o t h e r (for ( f o r example e x a m p l e design). d e s i g n ) . In I n particular, p a r t i c u l a r , this t h i s standard s t a n d a r d makes m a k e s no n o requirement r e q u i r e m e n t for f o r an a n independent i n d e p e n d e n t safety s a f e t y assessor, a s s e s s o r , since s i n c e this t h i s is i s a a matter m a t t e r for f o r ISO I S O 14971. 1 4 9 7 1 . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 75 7 5 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Annex A n n e x D D (informative) ( i n f o r m a t i v e ) Implementation I m p l e m e n t a t i o n D.1 D . 1 Introduction I n t r o d u c t i o n This T h i s annex a n n e x gives g i v e s an a n overview o v e r v i e w of o f how h o w this t h i s standard s t a n d a r d can c a n be b e implemented i m p l e m e n t e d into i n t o MANUFACTURERS’ M A N U F A C T U R E R S ’ PROCESSES. P R O C E S S E S . It I t also a l s o considers c o n s i d e r s that t h a t other o t h e r standards s t a n d a r d s like l i k e ISO I S O 13485 1 3 4 8 5 [8] [ 8 ] require r e q u i r e adequate a d e q u a t e and a n d comparable c o m p a r a b l e PROCESSES. P R O C E S S E S . D.2 D . 2 Quality Q u a l i t y management m a n a g e m e n t system s y s t e m For F o r MANUFACTURERS M A N U F A C T U R E R S of o f MEDICAL M E D I C A L DEVICES, D E V I C E S , including i n c l u d i n g MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E in i n the t h e context c o n t e x t of o f this t h i s standard, s t a n d a r d , the t h e establishment e s t a b l i s h m e n t of o f a a quality q u a l i t y management m a n a g e m e n t system s y s t e m (QMS) ( Q M S ) is i s required r e q u i r e d in i n 4.1. 4 . 1 . This T h i s standard s t a n d a r d does d o e s not n o t require r e q u i r e that t h a t the t h e QMS Q M S necessarily n e c e s s a r i l y has h a s to t o be b e certified. c e r t i f i e d . D.3 D . 3 EVALUATE E V A L U A T E quality q u a l i t y management m a n a g e m e n t PROCESSES P R O C E S S E S It I t is i s recommended r e c o m m e n d e d to t o EVALUATE E V A L U A T E how h o w well w e l l the t h e established e s t a b l i s h e d and a n d documented d o c u m e n t e d PROCESSES P R O C E S S E S of o f the t h e QMS Q M S already a l r e a d y cover c o v e r the t h e PROCESSES P R O C E S S E S of o f the t h e software s o f t w a r e life l i f e cycle, c y c l e , by b y means m e a n s of o f audits, a u d i t s , inspections, i n s p e c t i o n s , or o r analyses a n a l y s e s under u n d e r the t h e responsibility r e s p o n s i b i l i t y of o f the t h e MANUFACTURER. M A N U F A C T U R E R . Any A n y identified i d e n t i f i e d gaps g a p s can c a n be b e accommodated a c c o m m o d a t e d by b y extending e x t e n d i n g the t h e QM Q M PROCESSES, P R O C E S S E S , or o r can c a n be b e separately s e p a r a t e l y described. d e s c r i b e d . If I f the t h e MANUFACTURER M A N U F A C T U R E R already a l r e a d y has h a s PROCESS P R O C E S S descriptions d e s c r i p t i o n s available a v a i l a b l e which w h i c h regulate r e g u l a t e the t h e development, d e v e l o p m e n t , VERIFICATION V E R I F I C A T I O N and a n d validation v a l i d a t i o n of o f software, s o f t w a r e , then t h e n these t h e s e should s h o u l d also a l s o be b e EVALUATED E V A L U A T E D to t o determine d e t e r m i n e how h o w well w e l l they t h e y agree a g r e e with w i t h this t h i s standard. s t a n d a r d . D.4 D . 4 Integrating I n t e g r a t i n g requirements r e q u i r e m e n t s of o f this t h i s standard s t a n d a r d into i n t o the t h e MANUFACTURER’S M A N U F A C T U R E R ’ S quality q u a l i t y management m a n a g e m e n t PROCESSES P R O C E S S E S This T h i s standard s t a n d a r d can c a n be b e implemented i m p l e m e n t e d by b y adapting a d a p t i n g or o r extending e x t e n d i n g the t h e PROCESSES P R O C E S S E S already a l r e a d y installed i n s t a l l e d in i n the t h e QMS Q M S system, s y s t e m , or o r integrating i n t e g r a t i n g new n e w PROCESSES. P R O C E S S E S . This T h i s standard s t a n d a r d does d o e s not n o t specify s p e c i f y how h o w this t h i s is i s to t o be b e done; d o n e ; the t h e MANUFACTURER M A N U F A C T U R E R is i s free f r e e to t o do d o this t h i s in i n any a n y suitable s u i t a b l e way. w a y . The T h e MANUFACTURER M A N U F A C T U R E R is i s responsible r e s p o n s i b l e for f o r ensuring e n s u r i n g that t h a t the t h e PROCESSES P R O C E S S E S described d e s c r i b e d in i n this t h i s standard s t a n d a r d are a r e suitably s u i t a b l y put p u t into i n t o action a c t i o n when w h e n the t h e MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE S O F T W A R E is i s developed d e v e l o p e d by b y Original O r i g i n a l Equipment E q u i p m e n t Manufacturers M a n u f a c t u r e r s (OEM) ( O E M ) or o r sub-contractors s u b - c o n t r a c t o r s not n o t having h a v i n g their t h e i r own o w n documented d o c u m e n t e d QMS. Q M S . Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . D.5 D . 5 Checklist C h e c k l i s t for f o r small s m a l l MANUFACTURERS M A N U F A C T U R E R S without w i t h o u t a a certified c e r t i f i e d QMS Q M S The T h e MANUFACTURER M A N U F A C T U R E R should s h o u l d determine d e t e r m i n e the t h e highest h i g h e s t software s o f t w a r e safety s a f e t y classification c l a s s i f i c a t i o n (A, ( A , B B or o r C) C ) of o f the t h e software. s o f t w a r e . Table T a b l e D.1 D . 1 lists l i s t s all a l l ACTIVITIES A C T I V I T I E S described d e s c r i b e d in i n this t h i s standard. s t a n d a r d . The T h e reference r e f e r e n c e to t o ISO I S O 13485 1 3 4 8 5 should s h o u l d help h e l p to t o define d e f i n e the t h e place p l a c e in i n the t h e QMS. Q M S . Based B a s e d on o n the t h e required r e q u i r e d software s o f t w a r e safety s a f e t y class, c l a s s , the t h e MANUFACTURER M A N U F A C T U R E R should s h o u l d assess a s s e s s each e a c h required r e q u i r e d ACTIVITY A C T I V I T Y against a g a i n s t the t h e existing e x i s t i n g PROCESSES. P R O C E S S E S . If I f the t h e requirement r e q u i r e m e n t is i s already a l r e a d y covered, c o v e r e d , a a reference r e f e r e n c e to t o the t h e relevant r e l e v a n t PROCESS P R O C E S S descriptions d e s c r i p t i o n s should s h o u l d be b e given. g i v e n . If I f there t h e r e is i s discrepancy, d i s c r e p a n c y , an a n action a c t i o n is i s needed n e e d e d to t o improve i m p r o v e the t h e PROCESS. P R O C E S S . The T h e list l i s t can c a n also a l s o be b e used u s e d for f o r an a n EVALUATION E V A L U A T I O N of o f the t h e PROCESSES P R O C E S S E S after a f t e r the t h e action a c t i o n has h a s been b e e n performed. p e r f o r m e d . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 76 7 6 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Table T a b l e D.1 D . 1 – – Checklist C h e c k l i s t for f o r small s m a l l companies c o m p a n i e s without w i t h o u t a a certified c e r t i f i e d QMS Q M S ACTIVITY A C T I V I T Y Related R e l a t e d clause c l a u s e of o f ISO I S O 13485:2003 1 3 4 8 5 : 2 0 0 3 Covered C o v e r e d by b y existing e x i s t i n g procedure? p r o c e d u r e ? If I f yes: y e s : Reference R e f e r e n c e Actions A c t i o n s to t o be b e taken t a k e n 5.1 5 . 1 Software S o f t w a r e development d e v e l o p m e n t planning p l a n n i n g 7.3.1 7 . 3 . 1 Design D e s i g n and a n d development d e v e l o p m e n t planning p l a n n i n g Yes/No Y e s / N o 5.2 5 . 2 Software S o f t w a r e requirements r e q u i r e m e n t s analysis a n a l y s i s 7.3.2 7 . 3 . 2 Design D e s i g n and a n d development d e v e l o p m e n t inputs i n p u t s Yes/No Y e s / N o 5.3 5 . 3 Software S o f t w a r e ARCHITECTURAL A R C H I T E C T U R A L design d e s i g n Yes/No Y e s / N o 5.4 5 . 4 Software S o f t w a r e detailed d e t a i l e d design d e s i g n Yes/No Y e s / N o 5.5 5 . 5 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification v e r i f i c a t i o n Yes/No Y e s / N o 5.6 5 . 6 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing t e s t i n g Yes/No Y e s / N o 5.7 5 . 7 SOFTWARE S O F T W A R E SYSTEM S Y S T E M testing t e s t i n g 7.3.3 7 . 3 . 3 Design D e s i g n and a n d development d e v e l o p m e n t outputs o u t p u t s 7.3.4 7 . 3 . 4 Design D e s i g n and a n d development d e v e l o p m e n t review r e v i e w Yes/No Y e s / N o 5.8 5 . 8 Software S o f t w a r e release r e l e a s e 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n Yes/No Y e s / N o 6.1 6 . 1 Establish E s t a b l i s h software s o f t w a r e maintenance m a i n t e n a n c e plan p l a n 7.3.7 7 . 3 . 7 Control C o n t r o l of o f design d e s i g n and a n d development d e v e l o p m e n t changes c h a n g e s Yes/No Y e s / N o 6.2 6 . 2 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis a n a l y s i s Yes/No Y e s / N o 6.3 6 . 3 Modification M o d i f i c a t i o n implementation i m p l e m e n t a t i o n 7.3.5 7 . 3 . 5 Design D e s i g n and a n d development d e v e l o p m e n t verification v e r i f i c a t i o n 7.3.6 7 . 3 . 6 Design D e s i g n and a n d development d e v e l o p m e n t validation v a l i d a t i o n Yes/No Y e s / N o 7.1 7 . 1 Analysis A n a l y s i s of o f software s o f t w a r e contributing c o n t r i b u t i n g to t o hazardous h a z a r d o u s situations s i t u a t i o n s Yes/No Y e s / N o 7.2 7 . 2 RISK R I S K CONTROL C O N T R O L measures m e a s u r e s Yes/No Y e s / N o 7.3 7 . 3 VERIFICATION V E R I F I C A T I O N of o f RISK R I S K CONTROL C O N T R O L measures m e a s u r e s Yes/No Y e s / N o 7.4 7 . 4 RISK R I S K MANAGEMENT M A N A G E M E N T of o f software s o f t w a r e changes c h a n g e s Yes/No Y e s / N o 8.1 8 . 1 Configuration C o n f i g u r a t i o n identification i d e n t i f i c a t i o n 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d traceability t r a c e a b i l i t y Yes/No Y e s / N o 8.2 8 . 2 Change C h a n g e control c o n t r o l 7.5.3 7 . 5 . 3 Identification I d e n t i f i c a t i o n and a n d traceability t r a c e a b i l i t y Yes/No Y e s / N o 8.3 8 . 3 Configuration C o n f i g u r a t i o n status s t a t u s accounting a c c o u n t i n g Yes/No Y e s / N o 9 9 Software S o f t w a r e problem p r o b l e m resolution r e s o l u t i o n PROCESS P R O C E S S Yes/No Y e s / N o Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 77 7 7 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Bibliography B i b l i o g r a p h y IEC I E C 60601-1:2005, 6 0 6 0 1 - 1 : 2 0 0 5 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s for f o r basic b a s i c safety s a f e t y and a n d essential e s s e n t i a l performance p e r f o r m a n c e IEC I E C 60601-1:2005/AMD1:2012 6 0 6 0 1 - 1 : 2 0 0 5 / A M D 1 : 2 0 1 2 IEC I E C 60601-1-4:1996, 6 0 6 0 1 - 1 - 4 : 1 9 9 6 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s for f o r safety s a f e t y – – 4.Collateral 4 . C o l l a t e r a l standard: s t a n d a r d : Programmable P r o g r a m m a b l e electrical e l e c t r i c a l medical m e d i c a l systems s y s t e m s (withdrawn) ( w i t h d r a w n ) IEC I E C 60601-1-4:1996/AMD1:1999 6 0 6 0 1 - 1 - 4 : 1 9 9 6 / A M D 1 : 1 9 9 9 IEC I E C 60601-1-6, 6 0 6 0 1 - 1 - 6 , Medical M e d i c a l electrical e l e c t r i c a l equipment e q u i p m e n t – – Part P a r t 1-6: 1 - 6 : General G e n e r a l requirements r e q u i r e m e n t s for f o r basic b a s i c safety s a f e t y and a n d essential e s s e n t i a l performance p e r f o r m a n c e – – Collateral C o l l a t e r a l standard: s t a n d a r d : Usability U s a b i l i t y IEC I E C 61508-3, 6 1 5 0 8 - 3 , Functional F u n c t i o n a l safety s a f e t y of o f electrical/electronic/programmable e l e c t r i c a l / e l e c t r o n i c / p r o g r a m m a b l e electronic e l e c t r o n i c safety- s a f e t y - related r e l a t e d systems s y s t e m s – – Part P a r t 3: 3 : Software S o f t w a r e requirements r e q u i r e m e n t s IEC I E C 61010-1:2010, 6 1 0 1 0 - 1 : 2 0 1 0 , Safety S a f e t y requirements r e q u i r e m e n t s for f o r electrical e l e c t r i c a l equipment e q u i p m e n t for f o r measurement, m e a s u r e m e n t , control, c o n t r o l , and a n d laboratory l a b o r a t o r y use u s e – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s ISO I S O 9000:2005, 9 0 0 0 : 2 0 0 5 , Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Fundamentals F u n d a m e n t a l s and a n d vocabulary v o c a b u l a r y ISO I S O 9001:2008, 9 0 0 1 : 2 0 0 8 , Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Requirements R e q u i r e m e n t s ISO I S O 13485:2003, 1 3 4 8 5 : 2 0 0 3 , Medical M e d i c a l devices d e v i c e s – – Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Requirements R e q u i r e m e n t s for f o r regulatory r e g u l a t o r y purposes p u r p o s e s ISO/IEC I S O / I E C 12207:2008, 1 2 2 0 7 : 2 0 0 8 , Systems S y s t e m s and a n d software s o f t w a r e engineering e n g i n e e r i n g – – Software S o f t w a r e life l i f e cycle c y c l e processes p r o c e s s e s ISO/IEC I S O / I E C 14764:1999, 1 4 7 6 4 : 1 9 9 9 , Software S o f t w a r e Engineering E n g i n e e r i n g – – Software S o f t w a r e Life L i f e Cycle C y c l e Processes P r o c e s s e s – – Maintenance M a i n t e n a n c e ISO/IEC I S O / I E C 15504-5:2012, 1 5 5 0 4 - 5 : 2 0 1 2 , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Part P a r t 5: 5 : An A n exemplar e x e m p l a r software s o f t w a r e life l i f e cycle c y c l e process p r o c e s s assessment a s s e s s m e n t model m o d e l ISO/IEC I S O / I E C 25010:2011, 2 5 0 1 0 : 2 0 1 1 , Systems S y s t e m s and a n d software s o f t w a r e engineering e n g i n e e r i n g – – System S y s t e m and a n d software s o f t w a r e Quality Q u a l i t y Requirements R e q u i r e m e n t s and a n d Evaluation E v a l u a t i o n (SQuaRE) ( S Q u a R E ) – – System S y s t e m and a n d software s o f t w a r e quality q u a l i t y models m o d e l s ISO/IEC I S O / I E C 33001:— 3 3 0 0 1 : — 2) 2 ) , , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Concepts C o n c e p t s and a n d terminology t e r m i n o l o g y ISO/IEC I S O / I E C 33004:— 3 3 0 0 4 : — 2) 2 ) , , Information I n f o r m a t i o n technology t e c h n o l o g y – – Process P r o c e s s assessment a s s e s s m e n t – – Requirements R e q u i r e m e n t s for f o r process p r o c e s s reference, r e f e r e n c e , process p r o c e s s assessment a s s e s s m e n t and a n d maturity m a t u r i t y models m o d e l s ISO/IEC I S O / I E C 90003:2014, 9 0 0 0 3 : 2 0 1 4 , Software S o f t w a r e engineering e n g i n e e r i n g – – Guidelines G u i d e l i n e s for f o r the t h e application a p p l i c a t i o n of o f ISO I S O 9001:2008 9 0 0 1 : 2 0 0 8 to t o computer c o m p u t e r software s o f t w a r e Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . 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ISO/IEC I S O / I E C Guide G u i d e 51:2014, 5 1 : 2 0 1 4 , Safety S a f e t y aspects a s p e c t s – – Guidelines G u i d e l i n e s for f o r their t h e i r inclusion i n c l u s i o n in i n standards s t a n d a r d s IEEE I E E E 610.12:1990, 6 1 0 . 1 2 : 1 9 9 0 , IEEE I E E E standard s t a n d a r d glossary g l o s s a r y of o f software s o f t w a r e engineering e n g i n e e r i n g terminology t e r m i n o l o g y IEEE I E E E 1044:2009, 1 0 4 4 : 2 0 0 9 , IEEE I E E E standard s t a n d a r d classification c l a s s i f i c a t i o n for f o r software s o f t w a r e anomalies a n o m a l i e s 2 2 To T o be b e published. p u b l i s h e d . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} – – 78 7 8 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 U.S. U . S . Department D e p a r t m e n t Of O f Health H e a l t h and a n d Human H u m a n Services, S e r v i c e s , Food F o o d and a n d Drug D r u g Administration, A d m i n i s t r a t i o n , Guidance G u i d a n c e for f o r the t h e Content C o n t e n t of o f Premarket P r e m a r k e t Submissions S u b m i s s i o n s for f o r Software S o f t w a r e Contained C o n t a i n e d in i n Medical M e d i c a l Devices, D e v i c e s , May M a y 11, 1 1 , 2005, 2 0 0 5 , <://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u < : / / w w w . f d a . g o v / M e d i c a l D e v i c e s / D e v i c e R e g u l a t i o n a n d G u i d a n c e / G u i d a n c e D o c u m e n t s / u cm089543.htm> c m 0 8 9 5 4 3 . h t m > U.S. U . S . Department D e p a r t m e n t Of O f Health H e a l t h and a n d Human H u m a n Services, S e r v i c e s , Food F o o d and a n d Drug D r u g Administration, A d m i n i s t r a t i o n , General G e n e r a l Principles P r i n c i p l e s of o f Software S o f t w a r e Validation; V a l i d a t i o n ; Final F i n a l Guidance G u i d a n c e for f o r Industry I n d u s t r y and a n d FDA F D A Staff, S t a f f , January J a n u a r y 11, 1 1 , 2002, 2 0 0 2 , <http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf> < h t t p : / / w w w . f d a . g o v / d o w n l o a d s / R e g u l a t o r y I n f o r m a t i o n / G u i d a n c e s / u c m 1 2 6 9 5 5 . p d f > IEC I E C 62366-1:2015, 6 2 3 6 6 - 1 : 2 0 1 5 , Medical M e d i c a l devices d e v i c e s – – Part P a r t 1: 1 : Application A p p l i c a t i o n of o f usability u s a b i l i t y engineering e n g i n e e r i n g to t o medical m e d i c a l devices d e v i c e s IEC I E C 82304-1:— 8 2 3 0 4 - 1 : — 3), 3 ) , Healthcare H e a l t h c a r e Software S o f t w a r e Systems S y s t e m s – – Part P a r t 1: 1 : General G e n e r a l requirements r e q u i r e m e n t s Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . 3 3 In I n preparation. p r e p a r a t i o n . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 – – 79 7 9 – – +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 Index I n d e x of o f defined d e f i n e d terms t e r m s ACTIVITY, A C T I V I T Y , 15, 1 5 , 17, 1 7 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 33, 3 3 , 43, 4 3 , 59, 5 9 , 65, 6 5 , 67, 6 7 , 69, 6 9 , 73, 7 3 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 87, 8 7 , 89, 8 9 , 95, 9 5 , 113, 1 1 3 , 133, 1 3 3 , 145 1 4 5 Change C h a n g e control, c o n t r o l , 101 1 0 1 Change C h a n g e request, r e q u e s t , 61 6 1 Completion C o m p l e t i o n of, o f , 49 4 9 Configuration C o n f i g u r a t i o n identification, i d e n t i f i c a t i o n , 101 1 0 1 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 35 3 5 Configuration C o n f i g u r a t i o n status s t a t u s accounting, a c c o u n t i n g , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 Deliverable, D e l i v e r a b l e , 19 1 9 Design D e s i g n and a n d maintenance, m a i n t e n a n c e , 11 1 1 Hazard H a z a r d identification, i d e n t i f i c a t i o n , 11 1 1 Maintenance, M a i n t e n a n c e , 51 5 1 Mapping, M a p p i n g , 15 1 5 Modification M o d i f i c a t i o n implementation, i m p l e m e n t a t i o n , 97 9 7 Planning, P l a n n i n g , 83, 8 3 , 85 8 5 Problem P r o b l e m and a n d modification m o d i f i c a t i o n analysis, a n a l y s i s , 95 9 5 Problem P r o b l e m resolution, r e s o l u t i o n , 31, 3 1 , 53, 5 3 , 103 1 0 3 Required, R e q u i r e d , 15, 1 5 , 147 1 4 7 Requirements, R e q u i r e m e n t s , 17 1 7 Requirements R e q u i r e m e n t s analysis, a n a l y s i s , 39 3 9 Risk R i s k analysis, a n a l y s i s , 55 5 5 Risk R i s k management, m a n a g e m e n t , 33, 3 3 , 47, 4 7 , 59, 5 9 , 79, 7 9 , 81, 8 1 , 99 9 9 Software S o f t w a r e architectural a r c h i t e c t u r a l design, d e s i g n , 87 8 7 Software S o f t w a r e detailed d e t a i l e d design, d e s i g n , 89 8 9 Software S o f t w a r e development, d e v e l o p m e n t , 11 1 1 Software S o f t w a r e integration, i n t e g r a t i o n , 93 9 3 Software S o f t w a r e integration i n t e g r a t i o n and a n d integration i n t e g r a t i o n testing, t e s t i n g , 91 9 1 Software S o f t w a r e maintenance, m a i n t e n a n c e , 95 9 5 Software S o f t w a r e release, r e l e a s e , 95 9 5 Software S o f t w a r e requirements r e q u i r e m e n t s analysis, a n a l y s i s , 85 8 5 Software S o f t w a r e system s y s t e m testing, t e s t i n g , 93 9 3 SOFTWARE S O F T W A R E UNIT U N I T implementation i m p l e m e n t a t i o n and a n d verification, v e r i f i c a t i o n , 89 8 9 Testing, T e s t i n g , 45, 4 5 , 47 4 7 Verification, V e r i f i c a t i o n , 33 3 3 ANOMALY, A N O M A L Y , 45, 4 5 , 47, 4 7 , 49, 4 9 , 55, 5 5 , 65, 6 5 , 93 9 3 Definition, D e f i n i t i o n , 19 1 9 ARCHITECTURE, A R C H I T E C T U R E , 39, 3 9 , 41, 4 1 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 99, 9 9 , 113, 1 1 3 , 133 1 3 3 Definition, D e f i n i t i o n , 19 1 9 CHANGE C H A N G E REQUEST, R E Q U E S T , 53, 5 3 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 97, 9 7 , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 CONFIGURATION C O N F I G U R A T I O N ITEM, I T E M , 27, 2 7 , 35, 3 5 , 49, 4 9 , 59, 5 9 , 61, 6 1 , 97, 9 7 , 101 1 0 1 Definition, D e f i n i t i o n , 19 1 9 SOUP, S O U P , 31, 3 1 , 59 5 9 DELIVERABLE, D E L I V E R A B L E , 25, 2 5 , 31, 3 1 , 33 3 3 Definition, D e f i n i t i o n , 19 1 9 EVALUATION, E V A L U A T I O N , 41, 4 1 , 45, 4 5 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 87, 8 7 , 89, 8 9 , 93, 9 3 , 95, 9 5 , 99, 9 9 , 147, 1 4 7 , 149 1 4 9 Re-, R e - , 39 3 9 HARM, H A R M , 21, 2 1 , 23, 2 3 , 73, 7 3 , 81, 8 1 , 145 1 4 5 Definition, D e f i n i t i o n , 21 2 1 HAZARD, H A Z A R D , 11, 1 1 , 23, 2 3 , 29, 2 9 , 57, 5 7 , 67, 6 7 , 69, 6 9 , 79, 7 9 , 83, 8 3 , 93, 9 3 , 97, 9 7 , 99, 9 9 , 129 1 2 9 Definition, D e f i n i t i o n , 21 2 1 Unforeseen, U n f o r e s e e n , 87 8 7 MANUFACTURER, M A N U F A C T U R E R , 15, 1 5 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 35, 3 5 , 37, 3 7 , 39, 3 9 , 41, 4 1 , 43, 4 3 , 45, 4 5 , 47, 4 7 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 59, 5 9 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 107, 1 0 7 , 147 1 4 7 Definition, D e f i n i t i o n , 21 2 1 MEDICAL M E D I C A L DEVICE, D E V I C E , 11, 1 1 , 17, 1 7 , 21, 2 1 , 27, 2 7 , 35, 3 5 , 39, 3 9 , 41, 4 1 , 55, 5 5 , 69, 6 9 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 85, 8 5 , 87, 8 7 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 99, 9 9 , 105, 1 0 5 , 129, 1 2 9 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Definition, D e f i n i t i o n , 21 2 1 MEDICAL M E D I C A L DEVICE D E V I C E SOFTWARE, S O F T W A R E , 11, 1 1 , 13, 1 3 , 17, 1 7 , 27, 2 7 , 35, 3 5 , 37, 3 7 , 39, 3 9 , 51, 5 1 , 67, 6 7 , 73, 7 3 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 83, 8 3 , 85, 8 5 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 101, 1 0 1 , 105, 1 0 5 , 145, 1 4 5 , 147 1 4 7 Change, C h a n g e , 59 5 9 Definition, D e f i n i t i o n , 21 2 1 PROBLEM P R O B L E M REPORT, R E P O R T , 51, 5 1 , 53, 5 3 , 61, 6 1 , 63, 6 3 , 65, 6 5 , 95, 9 5 , 97 9 7 Classification, C l a s s i f i c a t i o n , 61 6 1 Definition, D e f i n i t i o n , 21 2 1 PROCESS, P R O C E S S , 13, 1 3 , 15, 1 5 , 17, 1 7 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 67, 6 7 , 69, 6 9 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 113, 1 1 3 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Acceptance, A c c e p t a n c e , 61 6 1 Change C h a n g e control, c o n t r o l , 61, 6 1 , 63 6 3 Classification, C l a s s i f i c a t i o n , 133 1 3 3 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 51, 5 1 , 89, 8 9 , 113 1 1 3 Decision-making, D e c i s i o n - m a k i n g , 77 7 7 Definition, D e f i n i t i o n , 23 2 3 Development, D e v e l o p m e n t , 27, 2 7 , 81, 8 1 , 95, 9 5 , 113 1 1 3 Existing, E x i s t i n g , 31 3 1 Improvement, I m p r o v e m e n t , 149 1 4 9 Life L i f e cycle, c y c l e , 11, 1 1 , 133, 1 3 3 , 143 1 4 3 Maintenance, M a i n t e n a n c e , 51, 5 1 , 53, 5 3 , 113 1 1 3 Mapping, M a p p i n g , 15 1 5 Modification, M o d i f i c a t i o n , 97 9 7 Omission O m i s s i o n of, o f , 81 8 1 Output, O u t p u t , 75 7 5 Physiological, P h y s i o l o g i c a l , 21 2 1 Problem P r o b l e m resolution, r e s o l u t i o n , 35, 3 5 , 45, 4 5 , 47, 4 7 , 51, 5 1 , 53, 5 3 , 63, 6 3 , 97, 9 7 , 101, 1 0 1 , 103, 1 0 3 , 113 1 1 3 Quality Q u a l i t y management, m a n a g e m e n t , 147 1 4 7 Required, R e q u i r e d , 15, 1 5 , 147 1 4 7 Requirements, R e q u i r e m e n t s , 17, 1 7 , 29 2 9 Risk R i s k analysis, a n a l y s i s , 73 7 3 Risk R i s k management, m a n a g e m e n t , 11, 1 1 , 23, 2 3 , 29, 2 9 , 33, 3 3 , 51, 5 1 , 63, 6 3 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 89, 8 9 , 99, 9 9 , 109, 1 0 9 , 113, 1 1 3 , 129, 1 2 9 , 133 1 3 3 Software, S o f t w a r e , 79, 7 9 , 145 1 4 5 Software S o f t w a r e development, d e v e l o p m e n t , 11, 1 1 , 27, 2 7 , 31, 3 1 , 53, 5 3 , 73 7 3 Software S o f t w a r e maintenance, m a i n t e n a n c e , 11, 1 1 , 95, 9 5 , 97 9 7 Software S o f t w a r e release, r e l e a s e , 133 1 3 3 System S y s t e m requirements, r e q u i r e m e n t s , 87 8 7 Verification, V e r i f i c a t i o n , 27 2 7 REGRESSION R E G R E S S I O N TESTING, T E S T I N G , 45, 4 5 , 65, 6 5 , 93 9 3 Definition, D e f i n i t i o n , 23 2 3 RISK, R I S K , 23, 2 3 , 67, 6 7 , 75, 7 5 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 91, 9 1 , 97, 9 7 , 99 9 9 Definition, D e f i n i t i o n , 23 2 3 Non-serious N o n - s e r i o u s injury, i n j u r y , 29 2 9 Reasonably R e a s o n a b l y foreseeable, f o r e s e e a b l e , 79 7 9 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Risk R i s k control, c o n t r o l , 23 2 3 Serious S e r i o u s injury, i n j u r y , 29 2 9 SOUP, S O U P , 33 3 3 Unacceptable, U n a c c e p t a b l e , 11, 1 1 , 25, 2 5 , 49 4 9 RISK R I S K ANALYSIS, A N A L Y S I S , 39, 3 9 , 55, 5 5 , 67, 6 7 , 73, 7 3 , 79, 7 9 , 87, 8 7 , 99, 9 9 , 145 1 4 5 Definition, D e f i n i t i o n , 23 2 3 RISK R I S K CONTROL C O N T R O L Activity, A c t i v i t y , 11 1 1 Definition, D e f i n i t i o n , 23 2 3 Hardware H a r d w a r e measure, m e a s u r e , 29 2 9 Measure, M e a s u r e , 29, 2 9 , 31, 3 1 , 37, 3 7 , 43, 4 3 , 45, 4 5 , 55, 5 5 , 57, 5 7 , 59, 5 9 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 93, 9 3 , 97, 9 7 , 99 9 9 Requirements, R e q u i r e m e n t s , 39, 3 9 , 41, 4 1 , 57, 5 7 , 99 9 9 Segregation, S e g r e g a t i o n , 41 4 1 RISK R I S K MANAGEMENT, M A N A G E M E N T , 11, 1 1 , 23, 2 3 , 29, 2 9 , 33, 3 3 , 47, 4 7 , 51, 5 1 , 53, 5 3 , 59, 5 9 , 63, 6 3 , 67, 6 7 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 85, 8 5 , 87, 8 7 , 89, 8 9 , 99, 9 9 , 109, 1 0 9 , 113, 1 1 3 , 129, 1 2 9 , 133, 1 3 3 , 145 1 4 5 Definition, D e f i n i t i o n , 23 2 3 Medical M e d i c a l device, d e v i c e , 75 7 5 Report, R e p o r t , 57 5 7 RISK R I S K MANAGEMENT M A N A G E M E N T FILE, F I L E , 17, 1 7 , 29, 2 9 , 55, 5 5 , 57, 5 7 , 63, 6 3 , 87, 8 7 , 89, 8 9 , 97 9 7 Definition, D e f i n i t i o n , 23 2 3 SAFETY, S A F E T Y , 11, 1 1 , 51, 5 1 , 63, 6 3 , 69, 6 9 , 77, 7 7 , 81, 8 1 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 103, 1 0 3 , 133, 1 3 3 , 143 1 4 3 Definition, D e f i n i t i o n , 25 2 5 SECURITY, S E C U R I T Y , 63 6 3 Definition, D e f i n i t i o n , 25 2 5 Requirements, R e q u i r e m e n t s , 37 3 7 SERIOUS S E R I O U S INJURY, I N J U R Y , 29, 2 9 , 83 8 3 Definition, D e f i n i t i o n , 25 2 5 Non-, N o n - , 29, 2 9 , 83 8 3 SOFTWARE S O F T W A R E DEVELOPMENT D E V E L O P M E N T LIFE L I F E CYCLE C Y C L E MODEL, M O D E L , 31, 3 1 , 73, 7 3 , 133 1 3 3 Definition, D e f i n i t i o n , 25 2 5 SOFTWARE S O F T W A R E ITEM, I T E M , 25, 2 5 , 27, 2 7 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 39, 3 9 , 41, 4 1 , 43, 4 3 , 53, 5 3 , 55, 5 5 , 57, 5 7 , 61, 6 1 , 65, 6 5 , 67, 6 7 , 69, 6 9 , 75, 7 5 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 87, 8 7 , 89, 8 9 , 91, 9 1 , 93, 9 3 , 97, 9 7 , 101, 1 0 1 , 111 1 1 1 Changed, C h a n g e d , 53 5 3 Definition, D e f i n i t i o n , 25 2 5 Integration, I n t e g r a t i o n , 43, 4 3 , 45 4 5 Partitioning, P a r t i t i o n i n g , 81 8 1 Performance, P e r f o r m a n c e , 45 4 5 Segregation, S e g r e g a t i o n , 41 4 1 SOUP, S O U P , 27, 2 7 , 33, 3 3 , 39 3 9 Software S o f t w a r e Of O f Unknown U n k n o w n Provenance P r o v e n a n c e See S e e SOUP, S O U P , 27 2 7 SOFTWARE S O F T W A R E PRODUCT, P R O D U C T , 19, 1 9 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 27, 2 7 , 31, 3 1 , 49, 4 9 , 51, 5 1 , 53, 5 3 , 59, 5 9 , 61, 6 1 , 65, 6 5 , 73, 7 3 , 77, 7 7 , 85, 8 5 , 89, 8 9 , 91, 9 1 , 97 9 7 Definition, D e f i n i t i o n , 25 2 5 Released, R e l e a s e d , 51, 5 1 , 53 5 3 – – 80 8 0 – – IEC I E C 62304:2006 6 2 3 0 4 : 2 0 0 6 +AMD1:2015 + A M D 1 : 2 0 1 5 CSV C S V � IEC I E C 2015 2 0 1 5 SOFTWARE S O F T W A R E SYSTEM, S Y S T E M , 21, 2 1 , 25, 2 5 , 29, 2 9 , 31, 3 1 , 33, 3 3 , 37, 3 7 , 43, 4 3 , 53, 5 3 , 59, 5 9 , 61, 6 1 , 69, 6 9 , 73, 7 3 , 77, 7 7 , 79, 7 9 , 81, 8 1 , 83, 8 3 , 85, 8 5 , 89, 8 9 , 93, 9 3 , 95, 9 5 , 111 1 1 1 Definition, D e f i n i t i o n , 25 2 5 Integration, I n t e g r a t i o n , 43 4 3 Requirements, R e q u i r e m e n t s , 35 3 5 Testing, T e s t i n g , 45, 4 5 , 47 4 7 SOFTWARE S O F T W A R E UNIT, U N I T , 25, 2 5 , 41, 4 1 , 43, 4 3 , 73, 7 3 , 77, 7 7 , 89, 8 9 , 91 9 1 Definition, D e f i n i t i o n , 27 2 7 Integration, I n t e g r a t i o n , 43 4 3 Verification, V e r i f i c a t i o n , 43 4 3 SOFTWARE S O F T W A R E UNIT U N I T Verification, V e r i f i c a t i o n , 41 4 1 SOUP, S O U P , 33, 3 3 , 35, 3 5 , 39, 3 9 , 41, 4 1 , 51, 5 1 , 55, 5 5 , 59, 5 9 , 75, 7 5 , 85 8 5 Change, C h a n g e , 59 5 9 Configuration C o n f i g u r a t i o n item, i t e m , 31 3 1 Definition, D e f i n i t i o n , 27 2 7 Designator, D e s i g n a t o r , 59 5 9 Software S o f t w a r e item, i t e m , 33 3 3 SYSTEM, S Y S T E M , 11, 1 1 , 19, 1 9 , 21, 2 1 , 23, 2 3 , 25, 2 5 , 31, 3 1 , 37, 3 7 , 39, 3 9 , 65, 6 5 , 73, 7 3 , 75, 7 5 , 79, 7 9 , 83, 8 3 , 85, 8 5 , 87, 8 7 , 101, 1 0 1 , 133 1 3 3 Configuration, C o n f i g u r a t i o n , 61 6 1 Definition, D e f i n i t i o n , 27 2 7 Development D e v e l o p m e n t plan, p l a n , 31 3 1 Existing, E x i s t i n g , 51 5 1 Released, R e l e a s e d , 53 5 3 Requirements, R e q u i r e m e n t s , 33, 3 3 , 35, 3 5 , 39, 3 9 , 41 4 1 TASK, T A S K , 15, 1 5 , 17, 1 7 , 19, 1 9 , 23, 2 3 , 25, 2 5 , 29, 2 9 , 31, 3 1 , 73, 7 3 , 83, 8 3 , 93, 9 3 , 95, 9 5 , 97, 9 7 , 143 1 4 3 Completion C o m p l e t i o n of, o f , 49 4 9 Configuration C o n f i g u r a t i o n management, m a n a g e m e n t , 35 3 5 Definition, D e f i n i t i o n , 27 2 7 Deliverable, D e l i v e r a b l e , 19 1 9 Design D e s i g n and a n d maintenance, m a i n t e n a n c e , 11 1 1 Maintenance, M a i n t e n a n c e , 51 5 1 Mapping, M a p p i n g , 15 1 5 Required, R e q u i r e d , 15 1 5 Requirements, R e q u i r e m e n t s , 17 1 7 Risk R i s k management, m a n a g e m e n t , 33 3 3 Verification, V e r i f i c a t i o n , 33 3 3 TRACEABILITY, T R A C E A B I L I T Y , 31, 3 1 , 57, 5 7 , 85, 8 5 , 87 8 7 Definition, D e f i n i t i o n , 27 2 7 Verification, V e r i f i c a t i o n , 25, 2 5 , 33, 3 3 , 35, 3 5 , 41, 4 1 , 43, 4 3 , 47, 4 7 , 49, 4 9 , 57, 5 7 , 61, 6 1 , 63, 6 3 , 69, 6 9 , 73, 7 3 , 75, 7 5 , 87, 8 7 , 91, 9 1 , 93, 9 3 , 97, 9 7 , 101, 1 0 1 , 113, 1 1 3 , 133, 1 3 3 , 145, 1 4 5 , 147 1 4 7 Definition, D e f i n i t i o n , 27 2 7 VERSION, V E R S I O N , 49, 4 9 , 55, 5 5 , 59, 5 9 , 65, 6 5 , 95, 9 5 , 101 1 0 1 Definition, D e f i n i t i o n , 27 2 7 Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . __________ _ _ _ _ _ _ _ _ _ _ granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Copyrighted C o p y r i g h t e d material m a t e r i a l licensed l i c e n s e d to t o Laurence L a u r e n c e Sampson S a m p s o n on o n 2016-10-27 2 0 1 6 - 1 0 - 2 7 for f o r licensee's l i c e n s e e ' s use u s e only. o n l y . No N o further f u r t h e r reproduction r e p r o d u c t i o n or o r networking n e t w o r k i n g is i s permitted. p e r m i t t e d . Distributed D i s t r i b u t e d by b y Thomson T h o m s o n Reuters R e u t e r s (Scientific) ( S c i e n t i fi c ) LLC, L L C , www.techstreet.com. w w w . t e c h s t r e e t . c o m . INTERNATIONAL I N T E R N A T I O N A L ELECTROTECHNICAL E L E C T R O T E C H N I C A L COMMISSION C O M M I S S I O N 3, 3 , rue r u e de d e Varembé V a r e m b é PO P O Box B o x 131 1 3 1 CH-1211 C H - 1 2 1 1 Geneva G e n e v a 20 2 0 Switzerland S w i t z e r l a n d Tel: T e l : + + 41 4 1 22 2 2 919 9 1 9 02 0 2 11 1 1 Fax: F a x : + + 41 4 1 22 2 2 919 9 1 9 03 0 3 00 0 0 info@iec.ch i n f o @ i e c . c h www.iec.ch w w w . i e c . c h 0.00 0.00 1.00 0.61 0.62 0.62 0.00 0.00 0.00 0.00 0.35 0.63 1.00 0.00 0.00 0.00 0.35 0.63