医学成像部门的评估和例行试验.第3-6部分:验收和恒定性试验.乳腺X射线摄影设备在乳腺X光断层合成操作模式中的成像性能

[中文适用范围]： 本部分IEC 61223适用于乳腺X射线设备在乳腺断层合成模式下运行时的性能，涉及图像质量和剂量。本文档的范围不包括：除乳腺断层合成以外的X射线设备运行模式；由断层合成图像合成的2D图像；除乳腺断层合成以外的重建断层摄影；由IEC 61223-3-5涵盖的乳腺CT扫描仪。本文档定义了：a) 描述乳腺X射线设备乳腺断层合成模式运行可接受标准的关键参数（关于图像质量和剂量）；b) 测试测量量是否符合规定公差的方法；c) 必要时恒定测试的频率。本文档旨在与IEC 61223-3-2或适用于乳腺断层合成模式运行的2D乳腺摄影等效方案中包含的可接受标准一起应用。这些方法主要依赖于使用适当测试设备进行的非侵入式测量，并在安装期间或安装后进行。覆盖安装步骤的签字声明可用作验收测试的一部分。当结果符合预期值时，建立后续恒定测试的基线值。 [外文原描述]： 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.