IEC 61223-3-5 Ed. 2.0 b:2019

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and constancy tests - Imaging performance of computed tomography X-ray equipment.

IEC 61223-3-5:2019 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/AMD1:2012AMD2:2016.

IEC 60601-2-44 and this document:

• 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, and
• evaluate 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,
• enable the early recognition of changes in the properties of components of the EQUIPMENT, and
• verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.

This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING 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.

IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous edition and to IEC 61223-2-6:

• modification of the RADIATION protection and control;
• modification of the acceptance testing;
• introduction of constancy testing.