IEC 60601-2-43 Medical Electrical Equipment - Special Requirements for the Safety of X-Ray Equipment for Interventional Procedures

Medical Device Tests

IEC 60601-2-43 Medical Electrical Equipment - Special Requirements for the Safety of X-Ray Equipment for Interventional Procedures

This standard specifies safety requirements for the design and manufacture of X-ray equipment for long-term radioscopically guided interventional procedures. Indicates the information to be provided with such equipment to assist the user and operator in managing the radiation risk from these procedures that may affect patients and personnel.

IEC 60601-2-43 Medical Electrical Equipment - Special Requirements for the Safety of X-Ray Equipment for Interventional Procedures

Its scope specifically does not include:

  • radiotherapy equipment;
  • Computed tomography equipment;
  • Accessories intended to be introduced to the patient;
  • Mammographic X-ray equipment;
  • Dental x-ray equipment.

The purpose of this particular standard is to specify specific essential safety and essential performance requirements for the design and manufacture of X-ray equipment for radioscopically guided interventional procedures. Specify the information to be provided with the interventional X-ray device in question to help the responsible agency and operator manage the risk of radiation and equipment failure from these procedures that could affect patients or staff.


EUROLAB assists manufacturers with IEC 60601-2-43 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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