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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
ICS Groups
11.040.01 Medical equipment in general 33.100.10 Emission 33.100.20 Immunity
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.04.2021
Amendment
EVS-EN 60601-1-2:2015/A1:2021
01.04.2021
Main + amendment
EVS-EN 60601-1-2:2015+A1:2021
03.12.2015
Main
EVS-EN 60601-1-2:2015
08.04.2010
Corrigendum
EVS-EN 60601-1-2:2007/AC:2010
05.12.2007
Main
EVS-EN 60601-1-2:2007

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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English (PDF 557 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English