IEC 60601-2-65:2012
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Appareils élecromédicaux - Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux
| Standard number: | IEC 60601-2-65:2012 |
| Released: | 2012-09-19 |
| Language: | English/French - Bilingual |
IEC 60601-2-65:2012
IEC 60601-2-65:2012 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.