IEC 60601-2-65:2012+AMD1:2017 CSV (Consolidated version)

Title

Language: EN Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Language: FR Appareils électromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

Abstract

Language: EN 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.

Language(s)
Language: EN Language: FR
Edition
1.1
Date of issue
17.05.2017
TC 62/SC 62B
ICS Codes
11.040.55
Publication number
60601
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Mandatory Standard according current regulation Mandatory Standard according current regulation

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