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About This Item

 

Full Description

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.
 

Document History

  1. IEC 60601-2-65 Ed. 1.2 en:2021


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

    • Historical Version
  2. IEC 60601-2-65 Ed. 1.2 b:2021


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

    • Most Recent
  3. IEC 60601-2-65 Ed. 1.1 b:2017


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

    • Historical Version
  4. IEC 60601-2-65 Ed. 1.0 b:2012

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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. IEC 60601-2-65 Amd.2 Ed. 1.0 b:2021


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

  2. IEC 60601-2-65 Amd.2 Ed. 1.0 en:2021


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

  3. IEC 60601-2-65 Amd.1 Ed. 1.0 b:2017


    Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment