標準號：BS EN 62464-1-2007
中文標準名稱：醫療成象磁共振設備.成像質量基本參數的測定
英文標準名稱：Magnetic resonance equipment for medical imaging - Determination of essential image quality parameters
標準類型：C43
發布日期：2007/7/31 12:00:00
實施日期：2007/7/31 12:00:00
中國標準分類號：C43
國際標準分類號：11.040.50
引用標準：IEC 60788
適用范圍：This international standard specifies measurement procedures for the determination of manyessential medical MR EQUIPMENT image quality parameters. Measurement procedures asaddressed 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 fortype 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 otherwisestated;- image quality affected by MR-compatibility issues;- special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy andimage-guided therapy applications;- type tests.The scope of this standard is also limited to measuring image quality characteristics in TESTDEVICES, not in PATIENT images.The measurement procedures specified in this standard are directed to:a) MANUFACTURERS, who can demonstrate compliance by performing acceptance andconstancy methods as described by this standard,b) test houses, which can confirm performance of MR EQUIPMENT using methods described inthis standard,c) regulatory authorities, who can reference this standard, andd) RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTSusing methods described in this standard.The essential image quality parameters and measurement methodologies defined in thisstandard 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 alternativemethods in Annex A. The preferred test methods may be substituted with the alternativemethods. If necessary, other methods not described in this standard may be used, providedthese other test methods are documented and validated against the methods described in thestandard. Validation of other test methods requires an analysis of test sensitivity to the sameparameter of interest and an analysis of the insensitivity of the test to other unrelatedparameters and should demonstrate a similar, or better, level of sensitivity to the sameparameter of interest and a similar, or better, level of robustness against unrelatedparameters. All methods shall produce quantitative results.The rationale to the preferred and alternate methods, and their pitfalls, are described inAnnex B.This standard also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENTquality assurance programs concerning essential image quality parameters. There are nopreferred CONSTANCY TEST methods, to provide flexibility in using existing automatedprocedures where available, but suggested examples of test methods are found in Annex A. Ifnecessary, other CONSTANCY TEST methods not described in this standard may be used. Sincethe needs of RESPONSIBLE ORGANISATIONS' quality assurance programs may vary, RESPONSIBLEORGANISATIONS are encouraged to determine the necessary scope of tests, quality of thetests, and the sensitivity of the data analysis etc. This standard places an emphasis onconsistently repeatable, automated measuring tools that facilitate trend analysis and thefrequent quick testing of a small set of important parameters which are sensitive to the overalloperating characteristics of the MR EQUIPMENT.