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ILNAS-EN 60601-2-57:2011 Edition 04/2011
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
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CLC/TC 76 : Optical radiation safety and laser equipment

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)    07/06/2011
start of the vote on the final project    12/11/2010   date of publication (dop)    07/12/2011
end of the vote on the final project    12/01/2011   date of withdrawal (dow)    07/03/2014


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/01/2012
Reference Mémorial A N° 2

Relations

Relations to international standards
IEC 60601-2-57:2011 (EQV) 

International Classification for Standards (ICS codes) :

11.040.50 : Radiographic equipment
11.040.60 : Therapy equipment

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