BS EN IEC 61223-3-5:2019 - Page 2

Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of computed tomography X-ray equipment | Status: Current

1 Scope and object This part of IEC 61223 applies to CT scanners that conform to IEC 60601‑2‑44:2009, IEC 60601‑2‑44:2009/AMD1:2012 and IEC 60601‑2‑44:2009/AMD2:2016. IEC 60601‑2‑44 and this document

• • defines 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 4.3,
• • defines the methods of testing the essential parameters, and
• • evaluates compliance with the tolerances of the parameters specified by the accompanying documents.

The methods defined in IEC 60601‑2‑44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the acceptance test report. This document applies to acceptance tests and constancy tests on a CT scanner. The aim of the acceptance tests is 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 document also contains requirements associated with acceptance test and constancy test for the accompanying documents of the CT scanner. This document does not apply to

• • aspects of mechanical and electrical safety, and
• • 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 1 If a user of this document wishes to apply this document to CT scanners that were designed to comply with editions of IEC 60601‑2‑44:2009 and earlier, understanding and adjustment for the different definitions that have been used for CTDIvol is critical. Additionally, the accompanying documents for CT scanners that were designed and manufactured to these older editions can be referenced to obtain applicable specifications.

NOTE 2 It is possible the accompanying documents that were compiled in accordance with IEC 60601‑2‑44:2009 and IEC 60601‑2‑44:2009/AMD1:2012 or IEC 60601‑2‑44:2009, IEC 60601‑2‑44:2009/AMD1:2012 and IEC 60601‑2‑44:2009/AMD2:2016 do not include all the needed content and specifications identified in this document prior to the completion of the transition period to this document.