EN 60601-1:2006/A13:2024

Medical electrical equipment - Part 1: General requirements for safety EN 60601-1:2006/A13:2024

General information

60.55 Ratification completed (DOR)   Feb 28, 2024

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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 legislation

Legislation related to this standard

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
EN 60601-1:2006

NOW

IN_DEVELOPMENT
EN 60601-1:2006/A13:2024
60.55 Ratification completed (DOR)
Feb 28, 2024

REVISED BY

IN_DEVELOPMENT
prEN IEC 60601-1