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EN 62464-1:2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

02-08-2022

Superseded by

EN IEC 62464-1:2019

Published date

05-04-2007

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INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and symbols
  3.1 Terms and definitions
  3.2 Symbols
4 Procedures for the determination of essential image parameters
  4.1 General requirements for all procedures
  4.2 SIGNAL TO NOISE RATIO
  4.3 UNIFORMITY
  4.4 SLICE THICKNESS in 2-D scanning
  4.5 Two-dimensional GEOMETRIC DISTORTION
  4.6 SPATIAL RESOLUTION
  4.7 GHOSTING ARTEFACTS
5 CONSTANCY TEST
  5.1 Objectives and rational
  5.2 Requirements for the TEST DEVICE
  5.3 Scan characteristics
  5.4 Measurement procedure
  5.5 Data analysis, reporting of results and tolerances
Annex A (normative) Alternative methods
Annex B (informative) Rationales
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
Bibliography
Index of defined terms

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.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, andd) 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.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.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

BS EN 60601-2-62:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
EN 60601-2-62:2015 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
NEMA MS 3:2008 (R2014) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

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