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FprEN IEC 60601-2-57:2023/prAA

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use FprEN IEC 60601-2-57:2023/prAA

General information

20.60 Close of comment period   May 14, 2024

CENELEC

CLC/TC 76 Optical radiation safety and laser equipment

European Norm

Scope

The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

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

Legislation 2017/745

Life cycle

PREVIOUSLY

IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023

NOW

IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023/prAA
20.60 Close of comment period
May 14, 2024