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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

General information
Valid from 03.12.2015
Base Documents
EN 60601-1-2:2015; IEC 60601-1-2:2014
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
01.04.2021
Amendment
01.04.2021
Main + amendment
03.12.2015
Main
08.04.2010
Corrigendum
05.12.2007
Main
EN 60601-1-2 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems (ME equipment and ME systems). Medical electrical equipment and medical electrical systems are expected to provide their basic safety and essential performance without interfering with other equipment and systems in the electromagnetic environments in which they are intended by their manufacturer to be used.

EN 60601-1-2 applies to basic safety and essential performance regarding electromagnetic disturbances of ME equipment and ME systems. The applicability of this collateral standard includes ME equipment and ME systems that have been found to have no essential performance. The text of IEC 60601-1-2:2014 has been approved in Europe as EN 60601-1-2:2015 without any changes.
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