tetml={filename={D:\drim\repository\projects\drim_124_0\metadata\9\a\9a75a43a90006e1931f363c4d2d38eb9\9a75a43a90006e1931f363c4d2d38eb9.tet.xml} elements={annotations=false bookmarks=false destinations=false fields=false javascripts = false} } granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} ses verre Publication @ BS EN 60601-2-52:2010+A1:2015 Incorporating corrigenda September 2010 and April 2011 Medical electrical equipment Part 2-52: Particular requirements for basic safety and essential performance of medical beds bsi. ..making excellence a habit: si! a ards Ins! Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networkin: g permitted without license from I HS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 BRITISH STANDARD Copyright British Standards Institution Provided by IHS under license with BSI- Uncontrolled Copy Noreproductionor networking permitted withoutlicense from IHS National foreword This British Standard is the UK implementation of EN 60601-2-52:2010+A1:2015, incorporating corrigendum April 2011. It is identical to IEC 60601-2-52:2009, incorporating amendment 1:2015 and corrigendum September2010. It supersedes BS EN 60601-2-52:2010 which will be withdrawn on 22 April 2018. Thestart and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by IEC corrigendum September 2010 is indicated in the text by Ci]. The start and finish of text introduced or altered by amendmentis indicated in the text by tags. Tags indicating changesto IEC text carry the numberof the IEC amendment. For example, text altered by IEC amendment1 is indicated by i. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment. A list of organizations represented on this committee can be obtained on request toits secretary. This publication does not purport to includeall the necessary provisions of a contract. Users are responsible for its correct application. © The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 82158 5 ICS 11.140 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published underthe authority of the Standards Policy and Strategy Committee on 31 May 2010. Amendments/corrigendaissued since publication Date Text affected 31 September 2011 Implementation of IEC corrigendum September 2010 and CENELEC corrigendum April 2011: modification of EN foreword 30 June 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015 Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis Not for Resale, 10/29/2015 08.09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Incorporating corrigendum April 2011 granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 2 – This European Standard is the result of a CENELEC lead joint collaboration between CLC/TC 62 and CEN/TC 293. granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} The text of document 62D/1186/FDIS, future IEC 60601-2-52:2009/A1, prepared by SC 62D "Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-52:2010/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement latest date by which the national standards conflicting with the document have to be withdrawn (dop) 2016-01-22 (dow) 2018-04-22 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive see informative Annex ZZ, included in EN 60601-2-52:2010. Endorsement notice The text of the International Standard IEC 60601-2-52:2009/A1:2015 was approved by CENELEC as a European Standard without any modification. granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 3 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 4 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 5 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) ........................................................................................... 1 1 1 1 1 2 2 4 4 4 . 4 4 4 5 5 5 5 6 7 8 8 1 1 1 1 1 1 2 2 2 8 9 granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 6 – . 30 30 3 3 3 3 3 3 4 4 4 50 50 50 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 7 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) 7 7 7 7 7 8 2 4 4 6 granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 8 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 9 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 10 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 11 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 12 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 13 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 14 – 201.3.219 * ADULT PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than 40 kg and a body mass index (BMI) equal to or more than 17 granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Clause 4 of the general standard applies, except as follows: 201.4.2.2 * General requirement for RISK MANAGEMENT Addition: The MANUFACTURER shall include, in the RISK MANAGEMENT PROCESS, HAZARDS related to PATIENTS taller than 185 cm. Compliance is checked by inspection of the RISK MANAGEMENT FILE. Key 2 1 1 Total weight 5,1 kg ±0,05 kg 2 Marked centre line 115 ±1 3 Surface roughness 1,6 4 Drilling hole for weight adjustment 0 228 ±1 Ø120 -0,5 3 Ø60 -0,5 0 Figure 201.103a) – Cone tool schematic 4 2 Dimensions in millimetres IEC granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Ø60 -0,5 0 Key Ø43,9 ±0,2 1 Total weight 3,34 kg ±0,05 kg 2 Marked centre line 3 Surface roughness 1,6 1 3 4 Drilling hole for weight adjustment +1 318 0 4 Figure 201.103b) – Cylinder tool schematic Figure 201.103 – Entrapment test tools Dimensions in millimetres 2 IEC granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 EN 60601-2-52:2010+A1:2015 (E) — 18 - 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows: 201.6.2 * Protection against electrical shock Addition: For APPLICATION ENVIRONMENT 4, the MEDICAL BED shall be CLASSII. 201.7 ME EQUIPMENTidentification, marking and documents Clause 7 of the general standard applies, except as follows: 201.7.2.2 Identification Replacementofthe first paragraph: The MEDICAL BED shall be marked with the name or trademark and address of the MANUFACTURER, MODEL OR TYPE REFERENCE and meansto allow traceability. The detachable components shall be marked with the name or trademark and addressof the MANUFACTURER, MODEL OR TYPE REFERENCE and meansto allow traceability unless mis- identification does not present an unacceptable RISK. Additional subclauses: 201.7.2.2.101 * Marking of maximum PATIENT weight and SAFE WORKING LOAD The MEDICAL BED shall be marked with the corresponding maximum PATIENT weight (see 201.9.8.3.1) and SAFE WORKING LOAD(for symbol see Figure 201.105). 1EC 2120/09 Figure 201.105 — Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD Detachable parts of a MEDICAL BED of a mass of more than 20 kg shall be marked with symbol ISO 7000-1321 (2004-01): LJ. 201.7.2.2.102 Marking for machine washable MEDICAL BEDS by an automatic washing system MEDICAL BEDS intended for use with an automatic washing system shall be marked with the following text to distinguish them from MEDICAL BEDS which cannot tolerate such cleaning methods: “Caution, for cleaning purposes this bed can be used with automatic washing systems.” Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} 201.7.2.2.107 Marking on the MEDICAL BED for ADULTS The MEDICAL BEDS shall be marked on a prominent place with the symbol indicated in Figure 201.106. Figure 201.120 – Physical description of an ADULT IEC granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 18 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 19 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 EN 60601-2-52:2010+A1:2015 (E) — 22 - 201.7.9.2 Instructions for use 201.7.9.2.1 General Addition: The instructions for use shall include: a) adescription according to 201.3. of the intended APPLICATION ENVIRONMENT(S); b) the maximum PATIENT weight and SAFE WORKING LOAD. The SAFE WORKING LOADis the sum of: the PATIENT; -— the mattress: — the ACCESSORIES of the MEDICAL BED (only if they are supported by the support system of the MEDICAL BED); and - the load supported by those ACCESSORIES (excluding PATIENT weight); c) an explanation of how to deactivate any MEDICAL BED function if movement caused bythat function could causeinjury to the PATIENT; d) for APPLICATION ENVIRONMENT 4 intended MEDICAL BEDS, the result of the measurement of auditable acoustic energy in accordance with ISO 3746. EF) e) a description of the intended PATIENT group(s). 201.7.9.2.2. Warning and safety notices Addition: a) The instructions for use shall provide a warning that the MEDICAL BED should beleft in its lowest position when the PATIENT is unattended in order to reduce RISK of injury due to falls. b) The instructions for use shall provide a warning on HAZARDS caused by inappropriate handling of the POWER SUPPLY CORD, e. g. by kinking, shearing or other mechanical damages. c) The instructions for use shall provide a warning, stating that when routing cables from other equipment in the MEDICAL BED, precautions shall be taken to avoid squeezing those betweenparts of the MEDICAL BED. d) The instructions for use shall provide a warning if a MEDICAL BED shall only be used with certain hoists, because of the limited space underneath the MEDICAL BED. e) The instructions for use shall provide a warningif a MEDICAL BEDis limited to a specific group of PATIENTS. f) The instructions for use shall provide a warning that incompatible siDE RAILS and mattresses can cause an entrapment hazard. 201.7.9.2.5 ME EQUIPMENT description Addition: 201.7.9.2.5.101 Selection of mattress The instructions for use shall contain information on the selection of mattress(es), including mattress dimensions and mattress characteristics (e.g. to reduce the RISK of entrapment and falls (see also 201.7.2.2.105)). 201.7.9.2.5.102 Selection of SIDE RAILS The instructions for use shall contain information on the selection of SIDE RAILS, including SIDE RAIL dimensions and SIDE RAIL characteristics (e.g. to reduce the RISK of entrapment and falls (see also 201.7.2.2.106)). Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} 201.7.9.2.5.103 * Angles and height of MEDICAL BED BS EN 60601-2-52:2010+A1:2015 -23- EN 60601-2-52:2010+A1:2015 (E) The instructions for use shall identify the maximum angles, which can be achieved in NORMAL USE by each part of the MATTRESS SUPPORT PLATFORMwith reference to horizontal. They shall also identify the maximum and minimum heights from the floor which can be achieved by the MATTRESS SUPPORT PLATFORM in NORMAL USE. They shall also identify any emergency position(s) and the controls by which such position(s) are obtained. 201.7.9.2.5.104 * Maximum massof MEDICAL BED The instructions for use shall identify the maximum mass (in kg) of the MEDICAL BED.If the MEDICALBEDis intended to be disassembledinto parts, the maximum mass(in kg) of any parts shall be stated in the instructions for use. 201.7.9.2.13 Maintenance Replacement: The instruction for use shall instruct the OPERATOR or RESPONSIBLE ORGANIZATION in sufficient detail concerning preventive inspection, maintenance and calibration to be performed by them, including the frequency of such maintenance. The instruction for use shall provide information for the safe performance of such routine maintenance necessary to ensure the continued safe use of the MEDICAL BED. Additionally, the instructions for use shall identify the parts on which preventive inspection and maintenance shall be performed by SERVICE PERSONNEL, including the periods to be applied and details about the actual performance of such maintenance. For MEDICAL BEDS containing rechargeable batteries that are intended to be maintained by anyone other than SERVICE PERSONNEL, the instruction for use shall contain instructions to ensure adequate maintenance. 201.8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies, except as follows: 201.8.11.3.2 Types Replacement: POWER SUPPLY CORDS shall be a minimum 2,5m measured from the plug to the outside perimeter of the MEDICAL BED. POWER SUPPLY CORDS and other external flexible mains cables and cords on MEDICAL BEDS shall be type HD22.10 H05-BQ-F [1]3) or equivalent quality for mechanical robustness. POWER SUPPLY CORDSshall be equipped with appropriate strain relief and bend protection. POWER SUPPLY CORD sets shall have a moulded-on plug or other means to withstand the ingress of water during the cleaning PROCESSfor which the MEDICAL BEDis intended. The MEDICAL BED shall be equipped with a means to keep the POWER SUPPLY CORDclear of any moving MEDICAL BED part or mechanism, when the MEDICAL BEDis in use, transport or not in use to avoid a damage of the POWER SUPPLY CORD. 3) Figures in square brackets refer to the bibliography. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 EN 60601-2-52:2010+A1:2015 (E) — 24- POWER SUPPLY CORDS shall be adequately protected against damages from contact with moving part(s) or from friction at sharp corners and edges within the MEDICAL BED. Compliance is checkedby inspection. 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies, except as follows: 201.9.1 * MECHANICAL HAZARDS Of ME EQUIPMENT Addition: 201.9.1.101 * Protection against PATIENT entrapment in non-moving parts Any openingsor areas (Aj, Ap, A3, Ag, As, Ag, B, C and D) within the MEDICAL BED system and which are above the MATTRESS SUPPORT PLATFORM Shall meet the dimensional and constructional requirements of Figures 201.107, 201.108 and Table 201.101. Where a RISK of PATIENT entrapment exists and is addressed in another way this shall be justified by the MANUFACTURERin the RISK MANAGEMENTFILE. Compliance is checked before and after application of the SIDE RAIL strength and latch reliability tests (see 201.9.8.3.3.3). Compliance is checked with the MATTRESS SUPPORT PLATFORM in the flat position unless otherwise noted as indicated in Table 201.101. The test shall be performed with the SIDE RAIL in all raised and locked positions. All the tests are performed without the mattress except the test for Dimension D. Requirements involving the mattress are checked with the mattress(es) as specified by the MANUFACTURER. Requirements of Figures 201.107, 201.108 and Table 201.101 involving the mattress are excluded for SPECIALTY MATTRESSES. A RISK ASSESSMENTShall be performed to evaluate: SPECIALTY MATTRESSES; MATTRESS OVERLAYS; ACCESSORIES; articulated MATTRESS SUPPORT PLATFORMpositions. Compliance is checkedbythe following tests and inspection of the RISK MANAGEMENT FILE. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Only applies when the area C above is 60 mm. A x represents the different areas A 1 , A 2 , A 3 , A 4 , A 5 and A 6 Key 1 Area of TOOL representing neck diameter (60 mm). 2 Area of TOOL representing chest breadth (318 mm). 3 Area of TOOL representing head breadth (120 mm). 4 MATTRESS SUPPORT PLATFORM 5 HEAD BOARD 6 FOOT BOARD 7 Mattress 8 SIDE RAIL Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL IEC granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Only applies when the area C is 60 mm. Key 1 Area of TOOL representing neck diameter (60 mm). 2 Area of TOOL representing chest breadth (318 mm). 3 Area of TOOL representing head breadth (120 mm). 4 MATTRESS SUPPORT PLATFORM 5 HEAD BOARD 6 FOOT BOARD 7 Mattress 8 SIDE RAIL Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL IEC granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 25 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 26 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 27 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 28 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 29 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 30 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 31 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 32 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 33 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 34 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 35 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 36 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 37 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 38 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 39 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 EN 60601-2-52:2010+A1:2015 (E) -— 42 - The fastenings of LIFTING POLES shall still function normally and present no HAZARDSafter the following tests. For the LIFTING POLE, permanent deformation is acceptable in the first test but a sudden movementof the LIFTING POLE shall be considered a HAZARD: 1) Compliance is checked by the following test: Position the LIFTING POLE to the MEDICAL BED in its most adverse position intended for use. Apply a downward load of two times the SAFE WORKING LOAD of LIFTING POLES (at least 1 500 N) to the outermost suspension point for the handle for at least 1 min, unless material creep may be an issue in which case the time shall be increased to at least 1 h. Examine the LIFTING POLE andits fastenings during and after application of the load. 2) Compliance is checked by the followingtest: Position the LIFTING POLE to the MEDICAL BEDin its most adverse position intended for use. Fixate the MEDICAL BED during the test if necessary due to instability. Apply perpendicular to the MEDICAL BED side a horizontal force of 350 N to the outermost Suspension point for the handle. Examine the LIFTING POLE andits fastenings during and after application of the load. 201.9.8.3.3 * Dynamic forces due to loading from persons Replacement: 201.9.8.3.3.1 General Where dynamic forces (due to sitting down, standing up, PATIENT handling PROCESS or the like) can be exerted on equipment parts intended to support or suspend a PATIENT in NORMAL USE, they shall not result in an unacceptable RISK. Durability shall be considered with regards to the most disadvantageous position of the MEDICALBED parts intended to support or suspend a PATIENT in NORMAL USE. Compliance is checked bythe following tests: Condition oftest: Place the worst-case mattress specified by MANUFACTURER onto the MEDICAL BEDin its flat position. If height-adjustable, adjust the height to the worse caseposition. Utilize loading pad (Figure 201.104) at position A in Figure 201.116, at whichever side is regarded to be the weaker. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 41 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 42 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 43 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 44 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 45 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 46 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 47 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 48 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 49 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 50 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 51 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 52 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 53 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 54 – Definition 201.3.201 – ADULT The body mass index is calculated by the following formula: Where: m in kg l in m Subclause 201.4.2 – RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS BMI The body mass index (BMI) as an additional measure for the shape of the human body was included in IEC 60601-2-52, since the physical size of some patients is indeed inside the limits of the first version of IEC 60601-2 52 (exceeding 146 cm and 40 kg) but nevertheless due to their particular atypical anatomy there might be a risk of being entrapped in the side rails. The body mass index (BMI) is a measure for the human body shape based on an individual's mass and height. BMI provides a simple numeric measure of a person's thickness or thinness, allowing health professionals to discuss overweight and underweight problems more objectively with their PATIENTS. For an explanation see also 201.1.1. Possible HAZARDS may be: rolling over the SIDE RAIL, entrapment in MEDICAL BED extension and HAZARDS related to the TRAPPING ZONES described in 201.9.2.2. m 2 l granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Subclause 201.5. 101 — Entrapmenttest tools BS EN 60601-2-52:2010+A1:2015 —57- EN 60601-2-52:2010+A1:2015 (E) The dimensions and weight of the cone tool and cylinder tool derived from the following observation: a) Cone tool: For a 95"" percentile male head this weight is 5,13 Kg (see Air Force Research Laboratory Design and Development of Anthropometrically Correct Head Forms for Joint Strike Fighter Ejection Seat Testing — February 2005). b) Cylinder tool: 60 mmis a conservative measure of 83 mm neck 5th percentile female. Subclause 201.6.2 — Protection against electrical shock In some countries a protective earthing system may not be available or reliable in the home environment (APPLICATION ENVIRONMENT4). Subclause 201.7.2.2.101 — Marking of maximum PATIENT weight and SAFE WORKING LOAD It is important that the RESPONSIBLE ORGANIZATION and/or OPERATOR clearly understand the maximum PATIENT weight and SAFE WORKING LOAD of the MEDICAL BED, and of any ACCESSORY that is intended to support potentially hazardous masses, so that the MEDICAL BED and its ACCESSORIES are not used in ways, which could create a HAZARD. Subclause 201.7.2.2.105 — Marking of replacement mattresses a] | IEC 2139/09 Figure AA.1 — Marking to select recommended mattresses specified by the MANUFACTURER Copyright British Standards Institution Provided by IHS under license with BSI Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08.09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 EN 60601-2-52:2010+A1:2015 (E) — 58 - Subclause 201.7.2.2.106 — Marking of detachable SIDE RAILS Ay IEC 2140/09 Figure AA.2 — Marking for detachable SIDE RAILS specified by the MANUFACTURER Subclause 201.7.9.2.5.103 — Angles and height of MEDICAL BED When determining the adjustable height range of the MEDICAL BED, consideration should be given to regional anthropometrics for both caregiver and/or OPERATOR and/or PATIENT. Attention should be paid to: — PATIENTfalling from the MEDICAL BED, where a low height minimizes injuries; — ease of PATIENT entry and egress; — transfers to and from a wheelchair; — caregivers’ and/or OPERATORS’ safe working height in order to minimize back problems. Subclause 201.7.9.2.5.104 — Maximum mass of MEDICAL BED Where a MEDICAL BED may be disassembled for transport by hand, knowledge of the mass of the main parts may be useful in avoiding strain. Subclause 201.9.1 — MECHANICAL HAZARDS of ME EQUIPMENT General rationale for 201.9.1.101, and 201.9.101: There are various recognized RISKS that have been accepted on the basis of RISK/benefit or RISK/RISK tradeoffs. SPECIALTY MATTRESSES are excluded from testing because the clinical benefits derived from such mattresses can outweigh the RISKS involved with their use, and it might not be possible to satisfy the test requirements without compromising the clinical benefit of the SPECIALTY MATTRESS. However this standard requires a RISK ASSESSMENT to be performed. The requirements are only applied with the MATTRESS SUPPORT PLATFORMin the flat position unless otherwise indicated. The reason is that there are various clinical benefits associated with the ability of MEDICAL BEDS to perform various articulations. It is not apparent how the functionality of MEDICAL BEDS, particularly the most advanced, most clinically beneficial beds, could be preserved if the requirements were extended to articulated positions. MANUFACTURERS are encouraged to understand the RISK involved and to strive to minimize this RISK by analysis and novel approaches to mitigation, while maintaining clinical utility of the bed. The dimensional requirements form a baseline, but they are not relevant to every bed application, and they may occasionally interfere with intended usage without mitigating RISK. The MANUFACTURERis responsible for justifying deviations for specialty beds or surfacesin the RISK ANALYSIS. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010+A1:2015 — 59 - EN 60601-2-52:2010+A1:2015 (E) Subclause 201.9.1.101 — Protection against PATIENT entrapment in non-moving parts The dimensional requirements listed in Figures 201.107 and 201.108 and in Table 201.101 are intended to restrict openings in and around the MEDICAL BED system so that parts of the anatomy cannot enter or can pass through easily. Each requirement is based on commonly available anthropometric data. PATIENTS most vulnerable to entrapment are those who have cognitive disability or have uncontrolled body movement. These PATIENTS most often arefrail, elderly or confused. Few adverse event reports indicate the angular position of the MATTRESS SUPPORT PLATFORM in which entrapment occurs, or what position the SIDE RAILS are in. Therefore this particular standard requires that entrapment be evaluated by the MANUFACTURER'S RISK ASSESSMENTin flat and articulated bed positions, with the SIDE RAILS fully raised and in intermediate positions. Three key body parts at RISK for life-threatening entrapment in MEDICAL BED systemsare the head, neck, and chest. e Head The 120 mm dimension is based on the 5" percentile Sri Lanka female head breadth, the distance across the face from ear to ear. Gaps < 120 mm were chosen as this dimension represents a conservative measurement to reduce entrapment. A dimension of 120 mm includes all 5'" percentile smallest female head breadth references and most 1° percentile international references. In case of a permanently FIXED mattress specifically dedicated to the MEDICAL BED and SIDE RAIL andif sliding of the mattress on the SUPPORT MATTRESS PLATFORMis not possible, the test is performed by inserting the 60 mm cylindrical end of the cone tool with 120 mm cone between the permanently FIXED mattress and the SIDE RAIL (Ay and A3 areas). e Neck The 60 mm dimensionis based on the 5" percentile width of a small adult female neck. It is noted that people of small stature have a 1° percentile female neck diameter of 79 mm (5"" percentile = 83 mm.). Several factors, such as neck compressibility, loss of muscle mass in the neck as PATIENTS age, and the asymmetrical shape of the neck, all support a conservative measure of less than 60 mm. To reduce the RISK of neck entrapment, gaps in the MEDICAL BED system should be small enough to prevent passage of a small neck. Additionally to reduce neck entrapment with regards to wedging of the neck, angles for V-shaped openings (Reference EN 13451-1) should be greater than 60°. The 60° angle reflects an understanding that at some point, a narrow angle creates a v-shape space or geometry that could be conducive to entrapment. The 60° angle was chosen by reviewing the TOOLS to assess entrapment RISK for swimming pool equipment (EN 13451-1, Swimming pool equipment -— Part 1: General safety requirements and test Methods), and a corresponding mathematical analysis which shows that when a cylinder-shaped weight is supported by two offsetting force vectors, each of the perpendicular forces becomes equal to the weight of the cylinder when the angles relative to the vertical are 60°. An assumption is made that 60° may be considered to be an inflection point for angles where wedging may become a prominent consideration (see Figures AA.5 and AA.6). See also Annex CC Particular guidance for assessing v-shaped opening Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Hill Rom Inc/0078415001, User=Laloge, Dennis No reproduction or networking permitted without license from IHS Not for Resale, 10/29/2015 08 09 16 MOT granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 58 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} – 59 – BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} BS EN 60601-2-52:2010 EN 60601-2-52:2010 (E) – 60 – granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} Text deleted – 61 – BS EN 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