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EVS-EN 60601-1:2006+A1:2013+A12:2014

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

General information

Valid from 02.03.2016
Base Documents
EN 60601-1:2006; IEC 60601-1:2005; EN 60601-1:2006/AC:2010; EN 60601-1:2006/A1:2013; EN 60601-1:2006/A12:2014; EN 60601-1:2006/AC:2014; IEC 60601-1/Amd 1:2012; IEC 60601-1/Amd 1/Cor 1:2014; IEC 60601-1/Cor 1:2006; IEC 60601-1/Cor 2:2007; EVS-EN 60601-1:2006+A1:2013+A12:2014/AC:2021
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
02.05.2024
Amendment
01.11.2021
Amendment
01.11.2021
Main + amendment
02.03.2016
Main + amendment
05.06.2014
Main + amendment
03.05.2012
Corrigendum
EVS-EN 60601-1:2006+A11:2011/AC:2012
04.04.2012
Main + corrigendum

EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is recognized that many items of medical electrical equipment and responsible organizations have to depend on standards to ensure essential performance and basic safety. Such areas include the accuracy with which the equipment controls the delivery of energy or therapeutic substances to the patient, or processes and displays physiological data that will affect patient management. EN 60601-1 can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In this consolidated version you can also find:

— the relationship between EN 60601-1 and the essential requirements of EU Directive 90/385/EEC on active implantable medical devices,

— 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.

Certain types of medical electrical equipment are either supplemented or modified by special requirements of a collateral or particular standard.

Required fields are indicated with *

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