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Norma
IEC 60601-2-57:2011

IEC 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

Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non-laser prévus pour des utilisations thérapeutiques, de diagnostic, de surveillance et de cosmétique/esthétique

Fecha:
2023-07-27 /Anulada
Resumen (inglés):
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.
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