UNE-EN IEC 61223-3-5:2019

This standard applies to CT SCANNERS that conform to IEC60601-2-44 Ed. 3.1 (2012) or later. The section of the ACCOMPANYING DOCUMENTS that pertain to ACCEPTANCE and CONSTANCY TESTING shall state the edition of IEC 60601-2-44 that the system has been designed and conforms to.

These standards

define the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and patient positioning; the list of parameters to be tested can be found in section 4.3.

define the methods of testing the essential parameters;

evaluate compliance with the tolerances of the parameters specified by the ACCOMPANYING DOCUMENTS.

These methods rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure may be usedas part of the ACCEPTANCE TEST report.

This standard applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS are to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.

This standard also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER.

This standard does not apply to:

aspects of mechanical and electrical safety;

aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.

NOTE: If a user of this standard wishes to apply this standard to CT SCANNERS that were designed to comply with editions of IEC 60601-2-44 Ed. 3.0 (2009) and earlier, care must be taken to understand and adjust for the different definitions that have been used for CTDIvol. Additionally, the ACCOMPANYING DOCUMENTS for CT scanners that were designed and manufactured to these older editions should be referenced to obtain the appropriate specifications that should be applied.