Standard

NEK EN 60601-2-65:2013

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Abstract

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 information

  • Standard from NEK
  • Published:
  • Edition: 2013-01
  • Version: 1
  • Document type: NAT
  • ICS 11.040.50
  • National Committee NEK/NK62

Legal references

EU law: 93/42/EEC

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