医学成像磁共振00716716设备 - 第1部分:基本图像质量参数的确定

[中文适用范围]： IEC 62464 的这一部分规定了确定 MR 设备许多基本图像质量参数的测量程序。本文件中所述的测量程序适用于验收测试中的 ?C 质量评估和稳定性测试中的 ?C 质量保证。并非所有测试都提供验收测试所需的性能水平。本文件不涉及静磁场强度大于 8 特斯拉的 MR 设备的图像质量评估，除非另有说明@ ?C 受 MR 兼容性问题影响的图像质量@ ?C 特殊诊断程序，例如血流成像@灌注@扩散@放射治疗和图像引导治疗应用@和?C型测试。本文档的范围还仅限于测量在 TEST DEVICES@ 上获取的图像中的图像质量特征，而不是在患者图像中测量图像质量特征。本文件中规定的测量程序适用于？C 制造商@，他们可以通过执行本文件@中描述的验收和稳定性测试来证明合规性。？C 测试机构@，他们可以使用本文件中描述的方法来确认MR设备的性能@？ C 监管机构@ 谁可以参考本文件@ 和？ C 负责任的组织谁想要使用本文件中描述的方法执行验收和稳定性测试 本文件中定义的基本图像质量参数和测量方法是？ C 信噪比@ ？ C 均匀性@ ?C 2-D 扫描中的切片厚度@ ?C 2-D 几何失真@ ?C 空间分辨率@ 和 ?C 重影伪影。这些程序中的每一个都可以单独执行或与任何其他程序结合执行。本文件描述了首选的测量程序。它还在附录 A 中描述了替代的规范方法。优选的测试方法可以用这些替代的规范方法替代。如有必要@可以使用本文档中未描述的其他方法@只要这些其他测试方法已记录并对照文档中描述的方法进行验证：这意味着通过与原始方法进行比较来完成分析，证明具有类似@或更好的方法@对相同感兴趣参数的敏感度水平以及对不相关参数的类似@或更好@的鲁棒性水平。所有方法都会产生定量结果。附件 B 中描述了首选和替代方法@的基本原理@及其陷阱@。本文件还提出了适用于涉及基本图像质量参数的 MR 设备质量保证计划的稳定性测试的要求。没有首选的稳定性测试方法@来提供使用现有自动化程序（如果可用）的灵活性@，但建议的测试方法示例可以在附件A中找到。本文件强调一致的可重复性@自动化测量工具，以促进趋势分析和对一小组重要参数进行频繁快速测试，这些参数对 MR 设备的整体操作特性敏感。注：本文件中发现的方法均未在高于 3 T 的静磁场强度下进行过广泛测试。初始测试表明，当使用适当的测试设备填充物时，这些方法可以正确运行。 [外文原描述]： IEC 62464-1:2018 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for – quality assessment in the ACCEPTANCE TEST, and – quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address – image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated, – image quality affected by MR-compatibility issues, – special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and – TYPE TESTS. The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images. The measurement procedures specified in this document are directed to – MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document, – test houses, who can confirm performance of MR EQUIPMENT using methods described in this document, – regulatory authorities, who can reference this document, and – RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document. The essential image quality parameters and measurement methodologies defined in this document are – SIGNAL TO NOISE RATIO, – UNIFORMITY, – SLICE THICKNESS in 2-D scanning, – 2-D GEOMETRIC DISTORTION, – SPATIAL RESOLUTION, and – GHOSTING ARTEFACTS. Each of these procedures can be performed standalone or in combination with any of the other procedures. This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these alternative normative methods. If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT. IEC 62464-1:2018 cancels and replaces the first edition published in 2007. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the tests have been revised to comply with the technical progress; b) the range of B0 was increased from 4 T to 8 T.