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现行 IEC 61223-3-2:2007
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Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment 医学成像部门的评估和日常测试 - 第3-2部分:验收测试 - 乳房X光机的成像性能
发布日期: 2007-07-10
IEC 61223的本部分适用于乳腺X射线摄影设备在图像质量和剂量方面的有效性,以及设备安全方面。 本标准适用于乳腺X射线摄影设备和乳腺立体定向设备。 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,前提是它们不是乳房X射线摄影设备的组成部分。这包括射线照相胶片、增感屏、射线照相盒、存储磷光体板和相关设备,如胶片处理器或存储磷光体板读取器、图像显示设备和硬拷贝相机。 对于射线照相盒和增感屏的测试,本标准参考ISO 4090。银幕胶片图像接收器的灵敏度和对比度应根据ISO 9236-3进行规定。 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。 当验收测试结果符合预期值时,将确定后续恒定性测试的基线值。 IEC 61223的本部分定义了 a) 描述上述性能的基本参数- 提及乳房X射线摄影设备的图像质量和剂量;和 b) 测试与这些参数相关的测量量是否符合规定公差的方法。 这些方法主要依赖于非侵入性测量,使用适当的测试设备,并在安装期间或之后执行。涵盖安装程序步骤的签字声明可作为验收测试的一部分。较高合规性水平要求的试验优先于较低合规性水平的类似试验。
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.
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归口单位: TC 62/SC 62B
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