WG 31 - TC 62/SC 62B/WG 31

IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose.
Excluded from the scope of this document are:
- MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS;
- 2D images synthesised from the tomosynthesis images;
- reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS;
- CT SCANNERS covered by IEC 61223-3-5.
IEC 61223-3-6:2020 defines
a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose,
b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and
c) CONSTANCY TEST frequency when required.
This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation.
These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.

IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.

This part of IEC 61223 applies to the effectiveness of mammographic X-ray equipment, with respect to image quality and dose, in combination with aspects of equipment safety. This standard applies to mammographic X-ray equipment and mammographic stereotactic devices. The tests described in this standard require the quality and performance of the X-ray image receptors to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-ray equipment. This includes radiographic films, intensifying screens, radiographic cassettes, storage phosphor plates and associated equipment such as film processors or storage phosphor plate readers, image display devices and hard copy cameras. For testing radiographic cassettes and intensifying screens, this standard makes reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are considered to be stated according to ISO 9236-3. By the measurements described in this standard, data for average glandular dose calculation can be determined. When the results of the acceptance test are in compliance with the expected values, the baseline values for the subsequent constancy tests are established. This part of IEC 61223 defines a) the essential parameters which describe the performance of the above-mentioned mammographic X ray equipment with regard to image quality and dose; and b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances. These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the acceptance test. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.