IEC 61223-3-8:2024 医学成像部门的评价和常规试验.第3-8部分:验收和稳定性试验.射线照相和射线透视用X射线设备的成像性能
标准编号：IEC 61223-3-8:2024
中文名称：医学成像部门的评价和常规试验.第3-8部分:验收和稳定性试验.射线照相和射线透视用X射线设备的成像性能
英文名称：Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
发布日期：2024-03-26
标准范围
IEC 61223-3-8:20 24适用于X？成像性能和相关质量控制参数的评价？符合IEC 60601-2-54:2022或IEC 60601-2-43:2022的射线照相和射线透视用射线设备。本文档适用于从图像采集、图像处理和图像显示的整个成像链的成像性能评估。本文件适用于验收测试和恒定性测试，它们是医学影像部门质量保证计划的一部分，旨在由负责组织执行或由负责组织负责。第A.2条详细讨论了这些测试在医疗放射设备生命周期中的位置。包括的方法主要依赖于使用适当测试设备的非侵入性测量，并在安装完成后根据制造商的安装说明进行。IEC 60601-2-54:2022和IEC 60601-2-43:2022要求向负责组织提供有关质量控制的信息。本文件为制造商提供了关于X？制造商提供的质量控制手册中的射线设备。附件G为此类手册提供了指导。
IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X？ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022.
This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display.
This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions.
IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X？ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.
标准预览图
