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IEC 60601-2-65-ed.1.1+Amd.1-CSV
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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STANDARD published on 17.5.2017
The information about the standard:
Designation standards: IEC 60601-2-65-ed.1.1+Amd.1-CSV
Publication date standards: 17.5.2017
SKU: NS-1099028
The number of pages: 184
Approximate weight : 583 g (1.29 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-65-ed.1.1+Amd.1-CSV :
IEC 60601-2-65:2012+A1:2017 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary. This consolidated version consists of the first edition (2012) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication. LIEC 60601-2-65:2012+A1:2017 sapplique a la securite de base et aux performances essentielles des appareils a rayonnement X dentaires intra-oraux et a ses composants principaux. Le domaine dapplication de la presente norme est limite aux appareils a rayonnement X dans lesquels la gaine equipee contient lensemble transformateur haute tension. Les appareils a rayonnement X dentaires extra-oraux sont exclus du domaine dapplication de la presente norme. La presente norme particuliere a ete preparee pour fournir, sur la base de lIEC 60601-1:2005 et de ses normes collaterales, un ensemble complet dexigences de securite de base et de performances essentielles pour les appareils a rayonnement X dentaires intra-oraux. Alors que les normes anterieures pour de tels appareils etaient consacrees aux composants et aux sous-systemes, la presente norme particuliere concerne le niveau systeme des appareils a rayonnement X dentaires intra-oraux. Les composants et leurs fonctions sont mentionnes dans la mesure ou cela est necessaire. Cette version consolidee comprend la premiere edition (2012) et son amendement 1 (2017). Il nest donc pas necessaire de commander lamendement avec cette publication.
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