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SSH EN 60601-2-57:2011

Pajisjet elektrike mjekësore - Pjesa 2-57: Kërkesa të veçanta të sigurisë bazë dhe performancës së nevojshme të pajisjeve të burimit të dritës jo-lazer të parashikuar për përdorim terapie, diagnostikimi, monitorimi dhe estetik/kozmetik

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
30 sht 2011

General information

60.60     30 sht 2011

DPS

DPS/KT 6

European Norm

11.040.50     11.040.60  

anglisht  

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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 directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Life cycle

NOW

PUBLISHED
SSH EN 60601-2-57:2011
60.60 Standard published
30 sht 2011

Related project

Adopted from EN 60601-2-57:2011

Adopted from IEC 60601-2-57 Ed. 1.0 b