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IEC 60601-2-65-ed.1.2+Amd.1+Amd.2-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 3.5.2021
The information about the standard:
Designation standards: IEC 60601-2-65-ed.1.2+Amd.1+Amd.2-CSV
Publication date standards: 3.5.2021
SKU: NS-1094375
The number of pages: 92
Approximate weight : 307 g (0.68 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-65-ed.1.2+Amd.1+Amd.2-CSV :
IEC 60601-2-65:2012+A1:2017+A2:2021 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. LIEC 60601-2-65:2012+A1:2017+A2:2021 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.
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