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EVS-EN 60601-1-6:2010+A1:2015

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

General information
Valid from 15.11.2019
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
Directives or regulations
None
Standard history
Status
Date
Type
Name
17.08.2021
Main + 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, design, VERIFY and VALIDATE 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.
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