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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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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
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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