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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

General information
Valid from 05.12.2007
Base Documents
IEC 60601-1-8:2006; EN 60601-1-8:2007
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
03.08.2021
Amendment
03.02.2020
Main + amendment
04.04.2017
Amendment
06.05.2013
Amendment
08.04.2010
Corrigendum
05.12.2007
Main
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.
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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
Amendment

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
Valid from 04.04.2017
Main

EVS-EN 60601-1-6:2010

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Valid from 07.06.2010
Main

EVS-EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Valid from 03.12.2015