prEN IEC 61223-3-8:2022

This part of IEC 61223 applies to evaluation of the performance of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY that conform to IEC 60601-2-54 or IEC 60601-2-43. NOTE Cone-beam CT is a MODE OF OPERATION in INTERVENTIONAL X-RAY EQUIPMENT. This standard discusses such MODE OF OPERATION in the informative Annex F. This standard applies to the evaluation of the performance of the entire imaging chain from image acquisition, image processing and image display. This standard applies to ACCEPTANCE TESTS and CONSTANCY TESTS, which are part of the QUALITY ASSURANCE PROGRAM in medical imaging departments and is intended to be performed by or under the responsibility of the RESPONSIBLE ORGANIZATION. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in A.2 of Annex A. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the MANUFACTURER’S installation instructions. IEC 60601-2-54 and IEC 60601-2-43 require information to be provided to the RESPONSIBLE ORGANIZATION with respect to QUALITY CONTROL. This standard provides guidance to MANUFACTURERS regarding the ACCEPTANCE and CONSTANCY TESTS for the X-RAY EQUIPMENT in a MANUFACTURER supplied QUALITY CONTROL manual. Annex G provides detailed guidance for such a manual.