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SRPS EN 60601-1:2012/A13:2024

Medical electrical equipment - Part 1: General requirements for safety

Jul 31, 2024

General information

60.60     Jul 31, 2024

ISS

N062

European Norm

11.040  

English  

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Scope

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN 60601-1:2012

NOW

PUBLISHED
SRPS EN 60601-1:2012/A13:2024
60.60 Standard published
Jul 31, 2024

Related project

Adopted from EN 60601-1:2006/A13:2024 IDENTICAL