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EVS-EN 60601-2-54:2009

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

General information
Valid from 06.11.2009
Base Documents
IEC 60601-2-54:2009; EN 60601-2-54:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
Main
prEN IEC 60601-2-54:2021
15.08.2019
Amendment
15.08.2019
Main + amendment
03.12.2015
Amendment
06.11.2009
Main
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.
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