1 | Page Bionic Arm Rotator Joint Spec[Example: The purpose of this document is to define the OP Block 79 Requirements for developing the Acme Medical Product ® ID Electroporation System][Example: The scope of this document is to specify the timing, electrode pattern, and current requirements of OP Block 79. Timing is to include the time delay after trigger press, impedance pulse timing, Electroporation pulse timing, and the time in-between pulses]4-3 - OP Block: Defines the treatment sequence which includes impedance timing, drug delivery timing, pulse timing and associated voltage and current parameters, as well as the Electrode pin configuration5-2 - Title 21 CFR Part 820 Quality System Regulation5-3 - EN ISO 13485:2016 Medical Devices - Quality management systems – Requirements for regulatory purposesEach requirement has a requirement ID in the form of OPB ### where OPB indicates that it is a Operational Requirements for Acme Medical Product ID, and ### is a unique number indicating the specific requirement number.When this document is updated and new requirements are added, the new requirements will begin with the next requirement ID number. The requirement numbers will not be duplicated. For example, if there is a requirement OPB, 12 there will not be another requirement OPB 12.If a requirement is requirement ID is deleted and is not reused.Note: Mechanical Requirement Requirements DO NOT serve as risk mitigation. There are be no standalone Mechanical Requirement requirements; each is derived from a higher level requirement>5-4 - ISO 14971:2007 Medical devices - Application of risk management to medical devices5-5 - EN ISO 14971:2012 Medical devices - Application of risk management to medical devices5-6 - M11-003704-01 Software Requirement Specification, Acme Medical Product® ID7.1-1 - This impedance will be calculated every 50 ms. ID MDT.L-33021 Alternate Id MDT.L-MER:382 Status Draft Severity Should Have7.1-2 - Contining 33021 ID MDT.L-36060 Alternate Id MDT.L-OPM-298 Status Draft Severity Should Have 7.4-1 - There shall be a noise filter add on to the microphone. ID MDT.L-35005 4 | Page Bionic Arm Rotator Joint Spec