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FprEN IEC 60601-2-57:2023

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

Publication date:   May 19, 2023

General information

50.60 Close of voting. Proof returned by secretariat   Jun 30, 2023

CENELEC

CLC/TC 76 Optical radiation safety and laser equipment

European Norm

11.040.50   Radiographic equipment | 11.040.60   Therapy equipment

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Scope

IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).

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

PUBLISHED
EN 60601-2-57:2011

NOW

IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023
50.60 Close of voting. Proof returned by secretariat
Jun 30, 2023

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023/prAA