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IEC 62464-1-ed.2.0
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
NORMA vydaná dňa 13.12.2018
Informácie o norme:
Označenie normy: IEC 62464-1-ed.2.0
Dátum vydania normy: 13.12.2018
Kód tovaru: NS-908729
Počet strán: 178
Približná hmotnosť: 565 g (1.25 libier)
Krajina: Medzinárodná technická norma
Kategória: Technické normy IEC
Kategórie - podobné normy:
Anotácia textu normy IEC 62464-1-ed.2.0 :
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. IEC 62464-1:2018 specifie les procedures de mesure pour la determination de la plupart des principaux parametres de qualite dimage des APPAREILS A RESONANCE MAGNETIQUE. Les procedures de mesure developpees dans le present document conviennent pour – levaluation de la qualite dans le cadre de LESSAI DACCEPTATION, et – lassurance qualite dans le cadre de LESSAI DE CONSTANCE. Les niveaux exiges de performances pour les ESSAIS DACCEPTATION ne sont pas indiques pour tous les essais. Le present document ne traite pas, – sauf indication contraire, de levaluation de la qualite dimage des APPAREILS A RESONANCE MAGNETIQUE ayant une intensite de champ magnetique statique superieure a 8 Tesla, – de la qualite dimage liee a des questions de compatibilite avec la resonance magnetique, – des procedures de diagnostic particulieres telles que limagerie de flux, de perfusion, de diffusion, de radiotherapie et les applications de therapie guidee par limagerie, et – des ESSAIS DE TYPE. Le domaine dapplication du present document se limite egalement a la mesure des caracteristiques de la qualite des images acquises sur des DISPOSITIFS DESSAI et non de celles des PATIENTS. Les procedures de mesure specifiees dans le present document sadressent – aux FABRICANTS, qui peuvent demontrer la conformite de leurs appareils par des ESSAIS DACCEPTATION et de CONSTANCE tels que decrits dans le present document, – aux laboratoires dessai, qui peuvent ainsi confirmer les performances DAPPAREILS A RESONANCE MAGNETIQUE au moyen de methodes decrites dans le present document, – aux autorites de reglementation, qui peuvent faire reference au present document, et – aux ORGANISMES RESPONSABLES qui souhaitent effectuer des ESSAIS DACCEPTATION et de CONSTANCE sur la base des methodes decrites dans le present document. Les principaux parametres de qualite dimage et les methodologies de mesure definis dans le present document sont les suivants: – le RAPPORT SIGNAL/BRUIT, – lUNIFORMITE, – lEPAISSEUR DE COUPE EN BALAYAGE 2D, – la DISTORSION GEOMETRIQUE 2D, – la RESOLUTION SPATIALE, – les ARTEFACTS DE FAUSSE IMAGE. Chacune de ces procedures peut etre realisee seule ou en combinaison avec lune des autres procedures. Le present document decrit les procedures de mesure preferentielles. Il decrit egalement, a l’Annexe A, dautres methodes normatives. Les methodes dessai preferentielles peuvent etre remplacees par ces autres methodes normatives. Si necessaire, dautres methodes qui ne sont pas decrites dans le present documen
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