IEC 62464-1-2007
医疗成象磁共振设备.第1部分:测定实际成象质量参数

Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters

IEC 62464-1-2007 发布历史

This international standard specifies measurement procedures for the determination of many essential medical MR EQUIPMENT image quality parameters. Measurement procedures as addressed in this standard are suitable for: - quality assessment in the ACCEPTANCE TEST; - quality assurance in the CONSTANCY TEST. In addition, the measurement procedures specified in this standard may also be useful for type tests, although that is not an objective of this standard. This standard does not address: - required levels of performance for ACCEPTANCE TEST and CONSTANCY TEST; - image quality assessment of high field MR EQUIPMENT greater than 4 T, 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; - type tests. The scope of this standard is also limited to measuring image quality characteristics in TEST DEVICES, not in PATIENT images. The measurement procedures specified in this standard are directed to: a) MANUFACTURERS, who can demonstrate compliance by performing acceptance and constancy methods as described by this standard, b) test houses, which can confirm performance of MR EQUIPMENT using methods described in this standard, c) regulatory authorities, who can reference this standard, and d) RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this standard. The essential image quality parameters and measurement methodologies defined in this standard are: - SIGNAL-TO-NOISE RATIO, - UNIFORMITY, - SLICE THICKNESS and SLICE PROFILE, - GEOMETRIC DISTORTION, - SPATIAL RESOLUTION, and - ghosting. This standard describes the preferred measurement procedures. It also describes alternative methods in Annex A. The preferred test methods may be substituted with the alternative methods. If necessary, other methods not described in this standard may be used, provided these other test methods are documented and validated against the methods described in the standard. Validation of other test methods requires an analysis of test sensitivity to the same parameter of interest and an analysis of the insensitivity of the test to other unrelated parameters and should demonstrate 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 shall produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This standard 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 are found in Annex A. If necessary, other CONSTANCY TEST methods not described in this standard may be used. Since the needs of RESPONSIBLE ORGANISATIONS' quality assurance programs may vary, RESPONSIBLE ORGANISATIONS are encouraged to determine the necessary scope of tests, quality of the tests, and the sensitivity of the data analysis etc. This standard 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 which are sensitive to the overall operating characteristics of the MR EQUIPMENT.

IEC 62464-1-2007由国际电工委员会 IX-IEC 发布于 2007-01。

IEC 62464-1-2007 在中国标准分类中归属于: C43 医用射线设备，在国际标准分类中归属于: 11.040.50 射线照相设备,35.240.80 信息技术在医药卫生技术中的应用。

IEC 62464-1-2007的历代版本如下：

• 2007年01月 IEC 62464-1-2007 医疗成象磁共振设备.第1部分:测定实际成象质量参数
• 2018年12月13日 IEC 62464-1-2018 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

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标准号

IEC 62464-1-2007

发布日期

2007年01月

实施日期

废止日期

无

中国标准分类号

C43

国际标准分类号

11.040.50;35.240.80

发布单位

IX-IEC

被代替标准

IEC 62B/641/FDIS-2006

适用范围

This international standard specifies measurement procedures for the determination of many essential medical MR EQUIPMENT image quality parameters. Measurement procedures as addressed in this standard are suitable for: - quality assessment in the ACCEPTANCE TEST; - quality assurance in the CONSTANCY TEST. In addition, the measurement procedures specified in this standard may also be useful for type tests, although that is not an objective of this standard. This standard does not address: - required levels of performance for ACCEPTANCE TEST and CONSTANCY TEST; - image quality assessment of high field MR EQUIPMENT greater than 4 T, 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; - type tests. The scope of this standard is also limited to measuring image quality characteristics in TEST DEVICES, not in PATIENT images. The measurement procedures specified in this standard are directed to: a) MANUFACTURERS, who can demonstrate compliance by performing acceptance and constancy methods as described by this standard, b) test houses, which can confirm performance of MR EQUIPMENT using methods described in this standard, c) regulatory authorities, who can reference this standard, and d) RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this standard. The essential image quality parameters and measurement methodologies defined in this standard are: - SIGNAL-TO-NOISE RATIO, - UNIFORMITY, - SLICE THICKNESS and SLICE PROFILE, - GEOMETRIC DISTORTION, - SPATIAL RESOLUTION, and - ghosting. This standard describes the preferred measurement procedures. It also describes alternative methods in Annex A. The preferred test methods may be substituted with the alternative methods. If necessary, other methods not described in this standard may be used, provided these other test methods are documented and validated against the methods described in the standard. Validation of other test methods requires an analysis of test sensitivity to the same parameter of interest and an analysis of the insensitivity of the test to other unrelated parameters and should demonstrate 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 shall produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This standard 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 are found in Annex A. If necessary, other CONSTANCY TEST methods not described in this standard may be used. Since the needs of RESPONSIBLE ORGANISATIONS' quality assurance programs may vary, RESPONSIBLE ORGANISATIONS are encouraged to determine the necessary scope of tests, quality of the tests, and the sensitivity of the data analysis etc. This standard 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 which are sensitive to the overall operating characteristics of the MR EQUIPMENT.

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