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EVS-EN 60601-1:2006/A1:2013

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

General information

Valid from 14.11.2013
Base Documents
IEC 60601-1:2005/A1:2012; EN 60601-1:2006/A1:2013
ICS Groups
11.040 Medical equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
EVS-EN 60601-1:2006+A1+A12+A2+A13:2024
02.03.2016
Corrigendum
EVS-EN 60601-1:2006/A1:2013/AC:2016
14.11.2013
Amendment
EVS-EN 60601-1:2006/A1:2013
03.05.2012
Corrigendum
EVS-EN 60601-1:2006+A11:2011/AC:2012
04.04.2012
Main + corrigendum
EVS-EN 60601-1:2006+A11:2011
02.11.2011
Amendment
EVS-EN 60601-1:2006/A11:2011
08.12.2006
Main + corrigendum
EVS-EN 60601-1:2006

EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. EN 60601-1:2006/A1:2013 modifies the European standard EN 60601-1:2006. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— normative references to international publications with their corresponding European publications,

— the relationship between EN 60601-1 and the essential requirements of EU Directive 93/42/EEC on medical devices.

Required fields are indicated with *

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Standard monitoring

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Main + amendment

EVS-EN 60601-1:2006+A1+A12+A2+A13:2024

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Main + corrigendum

EVS-EN 60601-1:2006

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Corrigendum

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Main + amendment

EVS-EN 62366-1:2015+A1:2020

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Information supplied by the manufacturer of medical devices
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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