IEC 62464-1:20 18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 -验收测试中的质量评估，以及 -恒定性试验中的质量保证。 并非所有测试都提供验收测试所需的性能水平。 本文档不涉及 -静态磁场强度大于8特斯拉的MR设备的图像质量评估，除非另有说明， -图像质量受到MR兼容性问题的影响， -特殊诊断程序，如血流成像、灌注、扩散、放射治疗和图像引导治疗应用，以及 -类型测试。 本文档的范围还限于测量在测试设备上采集的图像中的图像质量特征，而不是在患者图像中。本文件中规定的测量程序针对 -制造商，其可以通过执行本文件所述的验收和恒定性测试来证明合规性， -可以使用本文件中描述的方法确认MR设备性能的测试机构， -监管机构，可参考本文件，以及 -希望使用本文件中描述的方法进行验收和恒定性试验的负责组织。 本文档中定义的基本图像质量参数和测量方法是 -信噪比， -均匀性， -2-D扫描中的切片厚度， -2-D几何失真， -空间分辨率，以及 -重影文物。 这些程序中的每一个可以独立地执行或与任何其他程序组合执行。本文件描述了优选的测量程序。它还在附件A中描述了替代性规范方法。优选的测试方法可以用这些替代的标准方法代替。如有必要，可以使用本文件中未描述的其他方法，前提是这些其他测试方法已被记录并根据本文件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进行分析，证明对相同感兴趣参数具有相似或更好的灵敏度水平，以及对不相关参数具有相似或更好的稳健性水平。所有方法都会产生定量结果。 附件B描述了首选方法和替代方法的基本原理及其缺陷。 本文件还提出了适用于MR设备质量保证计划的关于基本图像质量参数的恒定性测试要求。没有首选的恒定性测试方法，以提供使用现有自动化程序的灵活性，但建议的测试方法示例可在附录A中找到。本文件强调始终可重复的自动化测量工具，这些工具有助于趋势分析和对MR设备整体运行特性敏感的一小部分重要参数的频繁快速测试。 IEC 62464-1:20 18取消并取代了2007年发布的第一版。本版构成技术修订版。 与上一版相比，此版本包括以下重大技术变更: A）？测试已根据技术进步进行了修订； b）？B0的范围从4 T增加到8 T。

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.