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IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 CSV

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IEC 60601-2-63:2012+A1:2017+A2:2021 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. 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 extra-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 extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: - the x-ray tube assembly contains the high-voltage transformer assembly; and - the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.

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  • Konsolidert fra IEC
  • Publisert:
  • Utgave: 1.2
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.040.50
  • ISO TC TC 62/SC 62B

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