Hivatkozási szám

MSZ EN 60601-2-57:2011

Dokumentumazonosító

151945

Cím

Gyógyászati villamos készülékek. 2-57. rész: Nem lézer fényforrású, terápiás, diagnosztikai, megfigyelési és kozmetikai/esztétikai alkalmazásra szánt készülékek alapvető biztonsági és lényeges működési követelményei (IEC 60601-2-57:2011)

Angol cím

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)

Alkalmazási terület

Replacement: This International Standard 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 photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope. LS 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, electrical or mechanical systems or sources of other radiation. NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive. 201.1.2 Object Replacement: The objects of this particular standard are: – to establish optical radiation safety, basic safety and essential performance requirements for LS EQUIPMENT; – to specify requirements for the MANUFACTURER to supply information and establish procedures so that proper precautions can be adopted; – to provide warning to individuals of HAZARDS associated with accessible OPTICAL RADIATION from LS EQUIPMENT through signs, labels and instructions; – to reduce the possibility of injury by minimizing unnecessary accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related to OPTICAL RADIATION through protective features and to assist safe use of LS EQUIPMENT; Replacement: This International Standard 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 photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT). This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope. Túl hosszú

ICS

11.040.50 Röntgenkészülékek

11.040.60 Terápiás berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2011-08-01

Forrás

idt EN 60601-2-57:2011; idt IEC 60601-2-57:2011

Előd

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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