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IEC 60601-2-28-ed.3.0
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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STANDARD published on 16.6.2017
The information about the standard:
Designation standards: IEC 60601-2-28-ed.3.0
Publication date standards: 16.6.2017
SKU: NS-686702
The number of pages: 48
Approximate weight : 144 g (0.32 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-28-ed.3.0 :
IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included. LIEC 60601-2-28:2017 s’applique a la securite de base et aux performances essentielles des gaines equipees et de leurs composants, destines au diagnostic medical et a l’imagerie. Lorsque la norme generale IEC 60601-1 et la norme collaterale IEC 60601-1-3, font reference aux appareils EM, cela doit etre interprete comme une reference aux gaines equipees dans la presente norme particuliere. Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux appareils EM ou uniquement aux systemes EM, son titre et son contenu l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique a la fois aux appareils EM et aux systemes EM, selon le cas. La troisieme edition de la presente norme particuliere a ete etablie pour correspondre a l’IEC 60601-1:2005 et a lIEC 60601-1:2005/AMD1:2012 (troisieme edition amendee de l’IEC 60601-1), qui est designee comme la norme generale. Outre les modifications relatives a l’amendement de l’IEC 60601-1, les modifications relatives aux ameliorations techniques sont egalement incluses.
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