DIN Standards Committee Dentistry
DIN EN 60601-2-57
; VDE 0750-2-57:2011-11
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 (IEC 60601-2-57:2011); German version EN 60601-2-57:2011
Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für kosmetische/ästhetische Zwecke (IEC 60601-2-57:2011); Deutsche Fassung EN 60601-2-57:2011
Overview
This product standard from the DIN EN 60601-1 (VDE 0750-1) series describes the safety requirements for 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. This equipment is referred to as light source equipment in the standard and may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation. The safety requirements only concern hazards to the eyes and skin. Hazards to internal tissues are outside the scope. The standard does not deal with equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. The informative annexes provide recommendations for the selection of goggles for personal eye protection and specify both requirements for manufacturers in connection with the classification of risk groups and the pictograms for identification of the light source equipment. The responsible committee is K 812 "Elektromedizinische Geräte" ("Electro-medical equipment") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
