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

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.

Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des principaux paramètres de qualité d'image

IEC 62464-1:2018 spécifie les procédures de mesure pour la détermination de la plupart des principaux paramètres de qualité d'image des APPAREILS À RÉSONANCE MAGNÉTIQUE. Les procédures de mesure développées dans le présent document conviennent pour
– l'évaluation de la qualité dans le cadre de L'ESSAI D'ACCEPTATION, et
– l'assurance qualité dans le cadre de L'ESSAI DE CONSTANCE.
Les niveaux exigés de performances pour les ESSAIS D'ACCEPTATION ne sont pas indiqués pour tous les essais.
Le présent document ne traite pas,
– sauf indication contraire, de l'évaluation de la qualité d'image des APPAREILS À RÉSONANCE MAGNÉTIQUE ayant une intensité de champ magnétique statique supérieure à 8 Tesla,
– de la qualité d'image liée à des questions de compatibilité avec la résonance magnétique,
– des procédures de diagnostic particulières telles que l'imagerie de flux, de perfusion, de diffusion, de radiothérapie et les applications de thérapie guidée par l'imagerie, et
– des ESSAIS DE TYPE.
Le domaine d'application du présent document se limite également à la mesure des caractéristiques de la qualité des images acquises sur des DISPOSITIFS D'ESSAI et non de celles des PATIENTS.
Les procédures de mesure spécifiées dans le présent document s'adressent
– aux FABRICANTS, qui peuvent démontrer la conformité de leurs appareils par des ESSAIS D'ACCEPTATION et de CONSTANCE tels que décrits dans le présent document,
– aux laboratoires d'essai, qui peuvent ainsi confirmer les performances D'APPAREILS À RÉSONANCE MAGNÉTIQUE au moyen de méthodes décrites dans le présent document,
– aux autorités de réglementation, qui peuvent faire référence au présent document, et
– aux ORGANISMES RESPONSABLES qui souhaitent effectuer des ESSAIS D'ACCEPTATION et de CONSTANCE sur la base des méthodes décrites dans le présent document.
Les principaux paramètres de qualité d'image et les méthodologies de mesure définis dans le présent document sont les suivants:
– le RAPPORT SIGNAL/BRUIT,
– l'UNIFORMITÉ,
– l'ÉPAISSEUR DE COUPE EN BALAYAGE 2D,
– la DISTORSION GÉOMÉTRIQUE 2D,
– la RÉSOLUTION SPATIALE,
– les ARTEFACTS DE FAUSSE IMAGE.
Chacune de ces procédures peut être réalisée seule ou en combinaison avec l'une des autres procédures.
Le présent document décrit les procédures de mesure préférentielles. Il décrit également, à l’Annexe A, d'autres méthodes normatives. Les méthodes d'essai préférentielles peuvent être remplacées par ces autres méthodes normatives. Si nécessaire, d'autres méthodes qui ne sont pas décrites dans le présent document peuvent être utilisées, sous réserve qu'elles soient documentées et validées par rapport aux méthodes décrites dans le présent document. Cela signifie qu'une analyse est effectuée par comparaison à la méthode d'origine, qui présente un niveau au moins équivalent de sensibilité par rapport à ce même paramètre et un niveau au moins équivalent de robustesse par rapport aux autres paramètres. Toutes les méthodes produisent des résultats quantitatifs.
L’Annexe B justifie le choix de méthodes préférentielles et alternatives ainsi que leurs inconvénients.
Le présent document présente également les exigences d'ESSAIS DE CONSTANCE qui conviennent à des programmes d'assurance qualité des APPAREILS À RÉSONANCE MAGNÉTIQUE pour ce qui concerne les principaux paramètres de qualité d'image. Afin de préserver la souplesse d'utilisation des procédures automatisées éventuellement existantes, il n'est pas donné de méthodes préférentielles D'ESSAI DE CONSTANCE. Toutefois, l’Annexe A suggère des exemples de méthodes d'essai. Le présent document met l'accent sur des outils de mesure automatisés et continuellement reproductibles qui facilitent les analyses de tendance ainsi que des essais fréquents et rapides d'un petit ensemble de paramètres importants, sensibles aux caractéristiques globales de fonctionnement des APPAREILS À RÉSONANCE MAGNÉTIQUE.
IEC 62464-1:2018 édition annule et remplace la première édition parue en 2007. Cett

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Status
Published
Publication Date
12-Dec-2018
Current Stage
PPUB - Publication issued
Completion Date
13-Dec-2018
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IEC 62464-1
Edition 2.0 2018-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Magnetic resonance equipment for medical imaging –
Part 1: Determination of essential image quality parameters
Appareils à résonance magnétique pour imagerie médicale –
Partie 1: Détermination des principaux paramètres de qualité d'image
IEC 62464-1:2018-12(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 62464-1
Edition 2.0 2018-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Magnetic resonance equipment for medical imaging –
Part 1: Determination of essential image quality parameters
Appareils à résonance magnétique pour imagerie médicale –
Partie 1: Détermination des principaux paramètres de qualité d'image
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-6292-4

Warning! Make sure that you obtained this publication from an authorized distributor.

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® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 62464-1:2018 © IEC 2018
CONTENTS

FOREWORD ........................................................................................................................... 6

INTRODUCTION ..................................................................................................................... 8

1 Scope ............................................................................................................................ 10

2 Normative references .................................................................................................... 11

3 Terms, definitions, symbols and abbreviated terms ........................................................ 11

3.1 Terms and definitions ............................................................................................ 11

3.2 Symbols and abbreviated terms ............................................................................ 15

4 * Procedures for the determination of essential image parameters ................................. 16

4.1 General requirements for all procedures ............................................................... 16

4.1.1 Requirements for the system ......................................................................... 16

4.1.2 Requirements for the TEST DEVICE .................................................................. 16

4.1.3 Scan parameters ........................................................................................... 16

4.1.4 Reporting of results ....................................................................................... 17

4.2 * SIGNAL TO NOISE RATIO ........................................................................................ 20

4.2.1 Objectives and rationale ................................................................................ 20

4.2.2 Requirements for the TEST DEVICE .................................................................. 20

4.2.3 Scan parameters ........................................................................................... 20

4.2.4 Measurement procedure ................................................................................ 20

4.2.5 Data analysis and tolerances ......................................................................... 21

4.2.6 Reporting of results ....................................................................................... 21

4.3 * UNIFORMITY ......................................................................................................... 22

4.3.1 Objectives and rationale ................................................................................ 22

4.3.2 Requirements for the TEST DEVICE .................................................................. 22

4.3.3 Scan parameters ........................................................................................... 22

4.3.4 Measurement procedure ................................................................................ 23

4.3.5 Data analysis and tolerances ......................................................................... 23

4.3.6 Reporting of results ....................................................................................... 23

4.4 SLICE THICKNESS in 2-D scanning ........................................................................... 24

4.4.1 Objectives and rationale ................................................................................ 24

4.4.2 Requirements for the TEST DEVICE .................................................................. 24

4.4.3 Scan parameters ........................................................................................... 25

4.4.4 Measurement procedure ................................................................................ 26

4.4.5 Data analysis and tolerances ......................................................................... 26

4.4.6 Reporting of results ....................................................................................... 27

4.4.7 Reporting of acceptance results ..................................................................... 27

4.5 * Two-dimensional GEOMETRIC DISTORTION ............................................................. 27

4.5.1 Objectives and rationale ................................................................................ 27

4.5.2 * Requirements for the TEST DEVICE ............................................................... 28

4.5.3 Scan parameters ........................................................................................... 30

4.5.4 * Measurement procedure .............................................................................. 30

4.5.5 * Data analysis and tolerances ...................................................................... 31

4.5.6 Reporting of results ....................................................................................... 32

4.6 * SPATIAL RESOLUTION ............................................................................................ 32

4.6.1 Objectives and rationale ................................................................................ 32

4.6.2 Requirements for the TEST DEVICE .................................................................. 32

4.6.3 Scan parameters ........................................................................................... 33

4.6.4 Measurement procedure ................................................................................ 34

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IEC 62464-1:2018 © IEC 2018 – 3 –

4.6.5 Data analysis and tolerances ......................................................................... 35

4.6.6 Reporting of results ....................................................................................... 35

4.6.7 Reporting of acceptance results ..................................................................... 36

4.7 * GHOSTING ARTEFACTS .......................................................................................... 36

4.7.1 Objectives and rationale ................................................................................ 36

4.7.2 * Requirements for the TEST DEVICE ............................................................... 36

4.7.3 Scan parameters ........................................................................................... 36

4.7.4 Measurement procedure ................................................................................ 37

4.7.5 Data analysis and tolerances ......................................................................... 37

4.7.6 Reporting of results ....................................................................................... 38

5 * CONSTANCY TEST .......................................................................................................... 39

5.1 Objectives and rationale ....................................................................................... 39

5.2 Requirements for the TEST DEVICE ......................................................................... 39

5.3 Scan characteristics .............................................................................................. 39

5.4 Measurement procedure ....................................................................................... 39

5.5 Data analysis, reporting of results and tolerances ................................................. 40

Annex A (normative) Alternative methods ............................................................................ 41

A.1 Pertaining to 4.2 SIGNAL TO NOISE RATIO ................................................................. 41

A.1.1 General ......................................................................................................... 41

A.1.2 Alternative method: SNR measurements using alternative noise

determination ................................................................................................. 41

A.1.3 Alternative method: SNR "single image" .......................................................... 42

A.2 Pertaining to 4.3 UNIFORMITY ................................................................................. 43

A.2.1 General ......................................................................................................... 43

A.2.2 Alternative method "grey-scale map" ............................................................. 43

A.2.3 Alternative method "ACR method" ................................................................. 45

A.3 Pertaining to 4.4SLICE THICKNESS in 2-D scanning ................................................. 45

A.3.1 General ......................................................................................................... 45

A.3.2 Alternative method: SLICE THICKNESS in 2-D scanning: wedge method ............ 46

A.4 Pertaining to 4.5 Two-dimensional GEOMETRIC DISTORTION ..................................... 48

A.4.1 General ......................................................................................................... 48

A.4.2 Alternative method: GEOMETRIC DISTORTION measurements using

elliptical boundary TEST DEVICES .................................................................... 48

A.4.3 Alternative method: 3D GEOMETRIC DISTORTION component measurement

method .......................................................................................................... 49

A.5 Pertaining to 4.6 SPATIAL RESOLUTION .................................................................... 56

A.5.1 General ......................................................................................................... 56

A.5.2 Alternative method: determination of the full MODULATION TRANSFER

FUNCTION ....................................................................................................... 57

A.6 Pertaining to 5 CONSTANCY TESTS .......................................................................... 58

A.6.1 Alternative CONSTANCY TEST methods ............................................................. 58

A.6.2 Pitfalls ........................................................................................................... 61

Annex B (informative) Rationale ........................................................................................... 62

B.1 Pertaining to 4 * Procedures for the determination of essential image

parameters ........................................................................................................... 62

B.2 Pertaining to 4.2 SIGNAL TO NOISE RATIO ................................................................ 62

B.2.1 Rationale ....................................................................................................... 62

B.2.2 References .................................................................................................... 75

B.3 Pertaining to 4.3 UNIFORMITY ................................................................................. 75

B.3.1 Rationale ....................................................................................................... 75

---------------------- Page: 5 ----------------------
– 4 – IEC 62464-1:2018 © IEC 2018

B.3.2 AAD method .................................................................................................. 75

B.3.3 Standing waves ............................................................................................. 75

B.4 Pertaining to 4.5 Two-dimensional GEOMETRIC DISTORTION ..................................... 76

B.4.1 Rationale ....................................................................................................... 76

B.4.2 Pitfalls ........................................................................................................... 77

B.5 Pertaining to 4.6 SPATIAL RESOLUTION .................................................................... 81

B.5.1 Rationale ....................................................................................................... 81

B.5.2 Pitfalls ........................................................................................................... 82

B.6 Pertaining to 4.7 GHOSTING ARTEFACTS .................................................................. 83

B.6.1 Rationale ....................................................................................................... 83

B.6.2 Pitfalls ........................................................................................................... 83

B.6.3 References .................................................................................................... 84

B.7 Pertaining to 5 CONSTANCY TEST – Rationale ......................................................... 84

Index of defined terms .......................................................................................................... 86

Bibliography .......................................................................................................................... 87

Figure 1 – Signal intensity profile in the inclined slab method ............................................... 25

Figure 2 – Correcting for rotation of TEST DEVICE ................................................................... 27

Figure 3 – Example of a boundary wall TEST DEVICE for a spherical specification

volume with two lines passing through the centre .................................................................. 29

Figure 4 – Example of a fiducial marker TEST DEVICE for a spherical specification

volume .................................................................................................................................. 30

Figure 5 – Distances to be determined .................................................................................. 31

Figure 6 – Periodic pattern .................................................................................................... 33

Figure 7 – Image of periodic pattern and position of ROI for coronal scans ............................ 34

Figure 8 – Image of periodic pattern and position of ROI for transverse and sagittal

scans .................................................................................................................................... 35

Figure 9 – Example image of the TEST DEVICE and region of interest (ROI) for signal,

ghost, and noise measurements............................................................................................ 38

Figure A.1 – Wedge TEST DEVICE ........................................................................................... 46

Figure A.2 – Measurement of SLICE PROFILE and SLICE THICKNESS using wedge TEST

DEVICE................................................................................................................................... 47

Figure A.3 – Determination of radius length of an ellipse with semi axis length a and b

forming an angle α with respect to the X axis ........................................................................ 49

Figure A.4 – Possible TEST DEVICE configurations for measuring GEOMETRIC DISTORTION ........ 51

Figure A.5 – Two elements with an apparent spacing of A (x,y) but a true spacing of

T (x,y) ................................................................................................................................... 53

Figure A.6 – A schematic of a spatial mapping GEOMETRIC DISTORTION plot ........................... 55

Figure A.7 – Scatter plot of GEOMETRIC DISTORTION error ....................................................... 56

Figure B.1 – Relaxation times T and T in dependency on the
1 2

concentration of CuSO x 5 H O .......................................................................................... 64

4 2

Figure B.2 – Centring error ................................................................................................... 78

Table 1 – Common parameters ............................................................................................. 18

Table 2 – Acquisition parameters .......................................................................................... 19

Table 3 – Reporting of results for SNR .................................................................................. 22

Table 4 – Reporting of results for UNIFORMITY ........................................................................ 23

---------------------- Page: 6 ----------------------
IEC 62464-1:2018 © IEC 2018 – 5 –

Table 5 – Reporting of results for SLICE THICKNESS ................................................................ 27

Table 6 – Reporting of results for GEOMETRIC DISTORTION ...................................................... 32

Table 7 – Phantom, plane and gradient orientation for resolution assessment....................... 34

Table 8 – Reporting of results for SPATIAL RESOLUTION........................................................... 36

Table 9 – Reporting of results for GHOSTING ARTEFACTS ......................................................... 38

Table 10 – Required CONSTANCY TESTS – Parameter settings ................................................ 40

Table A.1 – Reporting of results for UNIFORMITY "grey-scale map" ......................................... 44

Table A.2 – Recommended fiducial volumes ......................................................................... 52

Table A.3 – Example of error table ........................................................................................ 56

Table A.4 – Reporting of results for SPATIAL RESOLUTION (MTF method) ................................. 58

Table A.5 – Reporting of results for centre frequency ............................................................ 59

Table A.6 – Reporting of results for RF calibration ................................................................ 60

Table A.7 – Reporting of results for geometric accuracy ....................................................... 61

Table B.1 – TEST DEVICE conductivity and dielectric properties .............................................. 65

Table B.2 – Bandwidth-related quantities as provided by different vendors ........................... 67

Table B.3 – Relaxation fit parameters for Gd(TMHD) at concentrations ≤ 4 parts per

thousand by weight ............................................................................................................... 68

Table B.4 – Noise correction factors by number of complex channels ................................... 69

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– 6 – IEC 62464-1:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING –
Part 1: Determination of essential image quality parameters
FOREWORD

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International Standard IEC 62464-1 has been prepared by subcommittee 62B: Diagnostic

imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.

This second edition 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 B was increased from 4 T to 8 T.
---------------------- Page: 8 ----------------------
IEC 62464-1:2018 © IEC 2018 – 7 –
The text of this International Standard is based on the following documents:
CDV Report on voting
62B/1068/CDV 62B/1078/RVC

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:

• requirements, compliance with which can be tested, and definitions: roman type;

• explanations, advice, notes, general statements and
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