EN 60601-1-3 Test Standard for Radiation Protection, Basic Safety and Basic Performance in X-Ray Equipment

This supplementary standard applies to X-ray equipment and subgroups of such equipment in which radiological images of a human patient are used to diagnose, plan or guide medical procedures.

The purpose of this supplemental standard is to establish general requirements for protection against X-radiation in X-ray equipment so that irradiation of the human patient, operator, staff and members of the public can be kept as low as reasonably achievable. Without compromising the benefit of the radiological procedure. Certain standards may determine their appropriate value or measure for the general requirements set out in this supplemental standard. Application of general requirements or reference to a specific standard instead will be justified in the risk management process.

This supplemental standard only considers radiation protection issues related to X-radiation. The requirements for the control of electrical energy used to produce X-radiation, which is also an important aspect of radiation protection, are contained in IEC 60601-1 and in particular the standards for the safety and essential performance of the relevant equipment.

This standard supersedes and supersedes the first edition of IEC 1994-1973-407, published in 60601 (replacing IEC 1 published in 3). It constitutes a technical revision. This edition has been restructured and regulated in accordance with IEC 60601-1(2005) and focuses on the general requirements for radiation protection applicable to all diagnostic X-ray equipment. Specific requirements for certain equipment have been removed and will be covered by certain standards.

Our EUROLAB laboratory test experts, with their professional working mission and principles, offer you, the manufacturer and suppliers, the best service and controlled testing process in our accredited laboratories within the scope of EN 60601-1-3 test standard.