Standard

IEC 60601-2-54:2009+A1:2015+A2:2018 en

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

461,99 559,01 Incl BTW

About norm

Status Current
Number of pages 321
Committee Medische elektrische toestellen
Published on 01-06-2018
Language English
IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Details

ICS-code 11.040.50
Dutch title Medische elektrische toestellen - Deel 2-54: Bijzondere eisen voor de veiligheid en essentiële prestaties van röntgenapparatuur voor radiografie en radioscopie
English title Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Replaces

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