医用成像部门的评估及例行测试.第3-2部分:验收试验.乳腺摄影X射线设备的成像性能

[中文适用范围]： IEC 61223 的这一部分适用于乳腺 X 射线设备在图像质量和剂量方面的有效性，并结合设备安全方面。本标准适用于乳腺X线摄影设备和乳腺X线立体定向装置。当 X 射线图像接收器不是乳腺 X 射线设备的组成部分时，本标准中描述的测试要求在验收测试之前确保 X 射线图像接收器的质量和性能。这包括射线照相胶片、增感屏、射线照相暗盒、存储磷光板和相关设备，例如胶片处理器或存储磷光板读取器、图像显示设备和硬拷贝相机。对于测试射线照相暗盒和增感屏幕，本标准参考了 ISO 4090。屏幕胶片图像接收器的灵敏度和对比度被认为是根据 ISO 9236-3 规定的。注：目前尚无针对硬拷贝相机或图像显示设备验收测试的 IEC 标准。通过本标准中描述的测量，可以确定平均腺体剂量计算的数据。当验收测试的结果符合预期值时，就建立了后续稳定性测试的基线值。 IEC 61223 的这一部分定义了 a) 描述上述乳腺 X 射线设备在图像质量和剂量方面的性能的基本参数； b) 测试与这些参数相关的测量量是否符合规定的容差的方法。这些方法主要依赖于使用适当的测试设备并在安装期间或安装后进行的非侵入性测量。涵盖安装过程中步骤的签名声明可用作验收测试的一部分。较高合规性级别要求的测试优先于具有较低合规性级别的类似测试。这个概念在 4.1 中有描述。本标准本身并未规定所研究参数的极限值或公差。当胶片/屏幕组合、胶片处理化学物质或计算机射线照相系统发生变化时，验收测试的责任可能会出现困难。这是多种原因共同造成的。首先，图像接收器制造商和X射线设备制造商可能不同。其次，图像接收器或胶片处理化学物质的变化可能会改变系统性能。当发生上述系统集成时，执行验收测试非常重要。当发生可能改变系统性能的变更时，系统集成商（即负责此变更的任何人）必须与 X 射线设备制造商讨论其变更的影响，以便后者可以在必要时调整成像系统。乳腺 X 射线设备的验收测试需要医学物理学的一般技能。然而，有关谁执行测试的决定由当地规则（例如合同、法规、法律）决定。 [外文原描述]： 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.