SRPS EN 60601-1:2012

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

Publication date: Aug 27, 2012

General information

Current stage: 60.60 Effective date: Aug 27, 2012

Originator: ISS

Owner: N062

Type: European Norm

ICS: 11.040

Languages: English

Note: Sadrži Corrigendum March 2010.

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Status: Published

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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.

93/42/EEC

Medical devices

Harmonized

Directive 93/42/EEC

90/385/EEC

Active implantable medical devices

Harmonized

Directive 90/385/EEC

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

Directive 2017/745