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EVS-EN 60601-1-6:2010/A2:2021

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

General information

Valid from 03.08.2021
Base Documents
EN 60601-1-6:2010/A2:2021; IEC 60601-1-6:2010/A2:2020
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.08.2021
Main + amendment
03.08.2021
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/SC 62A subcommittee initiated a process to identify high-priority issues that need to be considered in an amendment and should not wait until the fourth edition of IEC 60601-1-6. Those issues selected for are addressed in Amendment 2.

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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Amendment

EVS-EN 60601-1-2:2015/A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Valid from 01.04.2021
Amendment

EVS-EN 60601-1-11:2015/A1:2021

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Valid from 03.08.2021
Amendment

EVS-EN 60601-1-8:2007/A2:2021

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Valid from 03.08.2021
Amendment

EVS-EN 60601-1:2006/A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
Valid from 01.11.2021