CEI EN IEC 61223-3-6

Scope and object

This part of IEC 61223 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.

This document 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.