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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/A1:2013; IEC 60601-1:2005/A1:2012; EN 60601-1:2006/A12:2014; EN 60601-1:2006/A1:2013/AC:2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
01.11.2021
Main + amendment
02.11.2011
Amendment

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+A12:2014 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:

— 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.

Required fields are indicated with *

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