prBAS EN 60601-1/A13:2026
Medical electrical equipment - Part 1: General requirements for safety
General information
Status:Project
Number of pages:48
Adoption method:Proglašavanje
Language:engleski
Edition:1.
Realization date:28.11.2025
Forseen date for next stage code:20.02.2026
Technical committee:BAS/TC 25, Healthcare
Directives:
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
ICS:
11.040, Medical equipment
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN 60601-1:2006/A13:2024, identical
Work material
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