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IEC 60601-2-28 X-Ray Tube Assemblies for Medical Diagnostics Testing

Medical electrical equipment – Part 2-28: the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-28 Scope:

IEC 60601 2 28 and EN 60601 2 28 testing applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof:

  • Hereafter referred to as medical electronic equipment;
  • Intended for medical diagnosis and imaging.

NOTE IEC 60601-2-28 is also applicable to the X-ray tube assembly aspects of X-ray source assemblies and X-ray tube heads.

Keystone Compliance assists manufacturers with IEC 60601-2-28 and EN 60601-2-28 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-28 test lab needs.