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EVS-EN 60601-1-6:2010+A1+A2:2021

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + IEC 60601-1-6:2010/A1:2013 + IEC 60601-1-6:2010/A2:2020)

General information
Valid from 17.08.2021
Base Documents
IEC 60601-1-6:2010; EN 60601-1-6:2010; IEC 60601-1-6:2010/A1:2013; EN 60601-1-6:2010/A1:2015; IEC 60601-1-6:2010/A2:2020; EN 60601-1-6:2010/A2:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.08.2021
Main + amendment
03.08.2021
Amendment
15.11.2019
Main + amendment
08.06.2015
Amendment
07.06.2010
Main
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. 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. NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
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