IEC 60601-1-6:2010/AMD2:2020
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Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French
22-07-2020
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
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