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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)

General information

Valid from 06.05.2013
Base Documents
IEC 60601-1-8:2006/A1:2012; EN 60601-1-8:2007/A1:2013
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.08.2021
Main + amendment
03.02.2020
Main + amendment
05.06.2014
Corrigendum
06.05.2013
Amendment
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/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 60601-1-8:2007

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
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