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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 08.06.2015
Base Documents
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
IEC 60601-1-6 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. IEC 60601-1-6:2010/A1:2013 is intended to clarify the elements of the usability engineering process that are required for compliance with the IEC 60601 series.

The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN 60601-1-6:2010/A1:2015 modifies the European standard EN 60601-1-6:2010.
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