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EVS-EN 60601-1-8:2007/A11:2017

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

General information
Valid from 04.04.2017
Base Documents
EN 60601-1-8:2007/A11:2017
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
17.08.2021
Main + amendment
03.02.2020
Main + amendment
04.04.2017
Amendment
05.12.2007
Main
Common modification for EN 60601-1-8:2007
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Amendment

EVS-EN 60601-1-8:2007/A1:2013

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 (IEC 60601-1-8:2006/A1:2012)
Valid from 06.05.2013
Main

EVS-EN 60601-1-8:2007

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 05.12.2007
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 60601-1-11:2015/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