Norm

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

Medische elektrische toestellen - Deel 2-54: Bijzondere eisen voor de veiligheid en essentiële prestaties van röntgenapparatuur voor radiografie en radioscopie

315,75

Over deze norm

Status Definitief
Aantal pagina's 289
Commissie Medische elektrische toestellen
Gepubliceerd op 01-04-2015
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and 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 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
Nederlandse titel Medische elektrische toestellen - Deel 2-54: Bijzondere eisen voor de veiligheid en essentiële prestaties van röntgenapparatuur voor radiografie en radioscopie
Engelse titel Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

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