IEC 61223-3-6:2020 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

标准编号：IEC 61223-3-6:2020

中文名称：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

英文名称：Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

发布日期：2020-02-07

标准范围

IEC 61223-3-6:20 20适用于乳腺X线摄影X射线设备在乳腺X线摄影断层合成操作模式下的图像质量和剂量性能。本文件范围不包括以下内容:-乳房X线摄影X射线设备操作模式，而不是乳房X线摄影断层合成；-从断层合成图像合成的2D图像；-除乳腺摄影断层合成之外的重建断层摄影；-IEC 61223-3-5涵盖的CT扫描仪。IEC 61223-3-6:20 20定义a)关于图像质量和剂量，描述乳腺摄影X射线设备的乳腺摄影断层合成操作模式的可接受标准的基本参数，b)测试与那些参数相关的测量量是否符合规定公差的方法，以及c)需要时的恒定性试验频率。本文件旨在与IEC 61223-3-2或同等2D乳腺摄影方案中包含的可接受性标准一起应用，这些标准也与乳腺摄影断层合成操作模式相关。这些方法主要依赖于使用适当测试设备并在安装期间或安装后进行的非侵入性测量。涵盖安装程序中步骤的签名声明可用作验收测试的一部分。较高合规级别要求的测试优先于较低合规级别的类似测试。当验收试验的结果符合期望值时，建立后续恒定性试验的基线值。

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.

标准预览图