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.pdf

标准号：IEC 62464-1-2007
实施状态：现行
中文名称：医疗成象磁共振设备.第1部分:测定实际成象质量参数
英文名称：Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
发布日期：2007-01
代替标准：IEC 62B/641/FDIS-2006
采用标准：DIN EN 62464-1-2009,IDT;BS EN 62464-1-2007,IDT;EN 62464-1-2007,IDT;NF C74-157-2007,IDTN-EN 62464-1-2007,IDT;UNE-EN 62464-1-2007,IDT
起草单位：IEC/SC 62B
标准简介：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.
文件格式：PDF
文件大小：1.35MB
文件页数：160
（以上信息更新时间为：2019-11-25）



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