医学成像部门的评估和例行试验.第3-5部分:验收试验和稳定性试验.计算机断层X射线设备的成像性能

[中文适用范围]： 本部分IEC 61223适用于符合IEC 60601-2-44:2009、IEC 60601-2-44:2009/AMD1:2012和IEC 60601-2-44:2009/AMD2:2016的CT扫描仪。IEC 60601-2-44和本文件定义了描述CT扫描仪性能的必备参数（涉及图像质量、辐射输出和患者定位），定义了测试这些必备参数的方法，并评估了由随附文件中指定的参数的公差是否符合性。本文档定义的方法依赖于非侵入式测量，使用适当的测试设备在安装期间或安装后进行。本文件适用于CT扫描仪的验收测试和恒定测试。验收测试的目的是验证安装或重大维修行动是否符合影响图像质量、辐射输出和患者定位的规范。恒定测试旨在确保设备的功能性能符合既定标准，并能尽早发现设备部件性能的变化，同时验证是否符合影响图像质量、辐射输出和患者定位的规范。 [外文原描述]： IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3, • defines the methods of testing the essential parameters, and • evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to • aspects of mechanical and electrical safety, and • aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning. IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing. The contents of the corrigendum of June 2022 have been included in this copy.