IEC 61223-3-5:2019 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

标准编号：IEC 61223-3-5:2019

中文名称：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

英文名称：Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and and constancy tests - Imaging performance of computed tomography X-ray equipment

发布日期：2019-09-16

标准范围

IEC 61223-3-5:20 19适用于符合IEC 60601-2-44:2009、IEC 60601-2-44:2009/AMD1:2012和IEC 60601-2-44:2009/AMD1:2012AMD2:2016的CT扫描仪。IEC 60601-2-44和本文件？定义描述CT扫描仪在图像质量、辐射输出和患者定位方面的性能的基本参数；待测参数列表见第4.3节，？定义测试基本参数的方法，以及？评估是否符合随附文件规定的参数公差。IEC 60601-2-44和本文件中定义的方法依赖于在安装期间或之后使用适当的测试设备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报告的一部分。本文件适用于CT扫描仪的验收测试和恒定性测试。验收测试的目的是验证安装或主要维修措施是否符合影响图像质量、辐射输出和患者定位的规范。进行恒定性试验是为了确保设备的功能性能符合既定标准，能够早期识别设备组件特性的变化，并验证是否符合影响图像质量、辐射输出和患者定位的质量标准。本文件还包含与CT扫描仪随附文件的验收和恒定性测试相关的要求。本文件不适用于？机械和电气安全方面，以及？机械、电气和软件性能方面，除非它们对于执行验收测试和恒定性测试至关重要，并且直接影响图像质量、辐射输出和患者定位。IEC 61223-3-5:20 19取消并取代了2004年发布的第一版和2006年发布的IEC 61223-2-6第二版。本版构成技术修订版。与上一版和IEC 61223-2-6相比，本版包括以下重大技术变更:1）辐射防护和控制的改造；2）验收测试的修改；3）恒定性测试的引入。

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.

标准预览图