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IEC 60601-2-43 X-Ray Equipment for Interventional Procedures Testing

Medical electrical equipment – Part 2-43: the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-43 Scope:

IEC 60601 2 43 and EN 60601 2 43 testing applies to the basic safety and essential performance of X-ray equipment declared by the manufacturer to be suitable for radioscopically guided interventional procedures, hereafter referred to as interventional X-ray equipment.

Its scope excludes, in particular:

  • Equipment for radiotherapy;
  • Equipment for computed tomography;
  • Accessories intended to be introduced into the patient;
  • Mammographic X-ray equipment;
  • Dental X-ray equipment.

NOTE 1 Examples of radioscopically guided interventional procedures, for which the use of interventional X-ray equipment complying with this standard is recommended, are given in Annex AA.

NOTE 2 Specific requirements for magnetic navigation devices, and for the use of interventional X-ray equipment in an operating room environment were not considered in IEC 60601-2-43; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.

NOTE 3 Interventional X-ray equipment when used in cross-sectional imaging mode (sometimes described as CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2]2. Additional requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.

Interventional X-ray equipment declared by the manufacturer to be suitable for radioscopically guided interventional procedures, which does not include a patient support as part of the system, is exempt from the patient support provisions of EN 60601-2-43.

Keystone Compliance assists manufacturers with IEC 60601-2-43 and EN 60601-2-43 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-43 test lab needs.