EN 60601-2-57:2011

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 and cosmetic/aesthetic use EN 60601-2-57:2011

Publication date:   Aug 17, 2011

General information

90.93 Standard confirmed   Oct 26, 2022

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 60601-2-57:2011 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 non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
EN 60601-2-57:2011
90.93 Standard confirmed
Oct 26, 2022

REVISED BY

IN_DEVELOPMENT
FprEN IEC 60601-2-57:2023