Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters (IEC 62464-1:2018)

This part of IEC 62464 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.
NOTE None of the methods found in this document have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.

Magnetresonanzgeräte für die medizinische Bildgebung - Teil 1: Bestimmung der wesentlichen Bildqualitätsparameter (IEC 62464-1:2018)

Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des principaux paramètres de qualité d’image (IEC 62464-1:2018)

La présente partie de l'IEC 62464 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. This is a preview - click here to buy the full publication 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.

Oprema za magnetno resonanco za medicinsko slikanje - 1. del: Ugotavljanje bistvenih parametrov za kakovost slike (IEC 62464-1:2018)

Ta del standarda IEC 62464 določa merilne postopke za ugotavljanje številnih bistvenih parametrov za kakovost slike za OPREMO ZA MAGNETNO RESONANCO. V tem dokumentu obravnavani merilni postopki so primerni za:
– oceno kakovosti pri PREVZEMNIH PRESKUSIH in
– zagotavljanje kakovosti pri PRESKUSIH NESPREMENLJIVOSTI.
Zahtevane ravni delovanja za PREVZEMNE PRESKUSE niso na voljo za vse preskuse.
Ta dokument ne obravnava:
– ocene kakovosti slike OPREME ZA MAGNETNO RESONANCO z jakostjo statičnega magnetnega polja več kot 8 enot tesla, če ni navedeno drugače,
– kakovosti slike, na katero vplivajo težave z združljivostjo z magnetno resonanco,
– posebnih diagnostičnih postopkov, kot so upodobitev pretoka, perfuzija, difuzija, radioterapija in slikovno vodena terapija, ter
– TIPSKIH PRESKUSOV.
Poleg tega je področje uporabe tega dokumenta omejeno na merjenje značilnosti kakovosti slik, pridobljenih s PRESKUSNIMI NAPRAVAMI, in ne slik PACIENTOV.
V tem dokumentu opredeljeni merilni postopki so namenjeni:
– PROIZVAJALCEM, ki izkazujejo skladnost z izvajanjem PREVZEMNIH PRESKUSOV in
PRESKUSOV NESPREMENLJIVOSTI, kot je opisano v tem dokumentu,
– ustanovam za preskušanje, ki lahko potrdijo delovanje OPREME ZA MAGNETNO RESONANCO z metodami, opisanimi v tem dokumentu,
– regulativnim organom, ki lahko uporabljajo ta dokument, ter
– ODGOVORNIM ORGANIZACIJAM, ki želijo izvajati PREVZEMNE PRESKUSE in PRESKUSE NESPREMENLJIVOSTI z metodami, opisanimi v tem dokumentu.
V tem dokumentu so opredeljeni naslednji bistveni parametri za kakovost slike in metodologije merjenja:
– RAZMERJE MED SIGNALOM IN HRUPOM,
– ENOTNOST,
– DEBELINA REZINE pri 2D-skeniranju,
– 2D-GEOMETRIČNO POPAČENJE,
– PROSTORSKA LOČLJIVOST in
– ARTEFAKTI PODVAJANJA.
Vsakega od teh postopkov je mogoče izvajati samostojno ali v kombinaciji s katerim koli drugim postopkom.
Ta dokument opisuje prednostne merilne postopke. Opisuje tudi alternativne normativne metode v dodatku A. Prednostne preskusne metode se lahko nadomestijo s temi alternativnimi normativnimi metodami. Po potrebi se lahko uporabijo druge metode, ki niso opisane v tem dokumentu, pod pogojem, da so te druge preskusne metode dokumentirane in potrjene v povezavi z metodami, opisanimi v dokumentu. To pomeni, da se v primerjavi s prvotno metodo opravi analiza, ki pokaže podobno ali boljšo raven občutljivosti na isti obravnavani parameter ter podobno ali boljšo raven robustnosti v povezavi z nepovezanimi parametri. Vse metode podajo kvantitativne rezultate. Razlogi za prednostne in alternativne metode ter njihove slabosti so opisani v dodatku B.
V povezavi z bistvenimi parametri kakovosti slike so v tem dokumentu predstavljene tudi zahteve za PRESKUSE NESPREMENLJIVOSTI, primerne za programe zagotavljanja kakovosti OPREME ZA MAGNETNO RESONANCO. Za PRESKUSE NESPREMENLJIVOSTI ne obstajajo nobene prednostne metode, s čimer se zagotovi prilagodljiva uporaba obstoječih avtomatiziranih postopkov, če so na voljo, predlagani primeri preskusnih metod pa so navedeni v dodatku A. Ta dokument poudarja pomembnost uporabe dosledno ponovljivih avtomatiziranih merilnih orodij za lažjo analizo trendov in redno hitro preskušanje majhnega nabora pomembnih parametrov, ki so občutljivi na splošne značilnosti delovanja OPREME ZA MAGNETNO RESONANCO.
OPOMBA: Nobena od metod, navedenih v tem dokumentu, ni bila obsežno preskušena pri jakosti statičnega magnetnega polja nad 3 T. Začetni preskusi kažejo, da metode delujejo pravilno, kadar se uporabljajo ustrezna polnila PRESKUSNIH NAPRAV.

General Information

Status
Published
Publication Date
26-Mar-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Mar-2019
Due Date
23-May-2019
Completion Date
27-Mar-2019

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SLOVENSKI STANDARD
SIST EN IEC 62464-1:2019
01-maj-2019
1DGRPHãþD
SIST EN 62464-1:2010
Oprema za magnetno resonanco za medicinsko slikanje - 1. del: Ugotavljanje
bistvenih parametrov za kakovost slike (IEC 62464-1:2018)

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

image quality parameters (IEC 62464-1:2018)
Magnetresonanzgeräte für die medizinische Bildgebung - Teil 1: Bestimmung der
wesentlichen Bildqualitätsparameter (IEC 62464-1:2018)

Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des

principaux paramètres de qualité d’image (IEC 62464-1:2018)
Ta slovenski standard je istoveten z: EN IEC 62464-1:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN IEC 62464-1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 62464-1:2019
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SIST EN IEC 62464-1:2019
EUROPEAN STANDARD EN IEC 62464-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2019
ICS 11.040.50 Supersedes EN 62464-1:2007
English Version
Magnetic resonance equipment for medical imaging - Part 1:
Determination of essential image quality parameters
(IEC 62464-1:2018)

Appareils à résonance magnétique pour imagerie médicale Magnetresonanzgeräte für die medizinische Bildgebung -

- Partie 1: Détermination des principaux paramètres de Teil 1: Bestimmung der wesentlichen Bildqualitätsparameter

qualité d'image (IEC 62464-1:2018)
(IEC 62464-1:2018)

This European Standard was approved by CENELEC on 2019-01-17. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,

Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 62464-1:2019 E
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SIST EN IEC 62464-1:2019
EN IEC 62464-1:2019 (E)
European foreword

The text of document 62B/1068/CDV, future edition 2 of IEC 62464-1, prepared by SC 62B

"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was

submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 62464-1:2019.

The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2019-10-17

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-01-17

document have to be withdrawn
This document supersedes EN 62464-1:2007.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 62464-1:2018 was approved by CENELEC as a European

Standard without any modification.

In the official version, for Bibliography, the following note has to be added for the standard indicated:

IEC 61223-3-5:2004 NOTE Harmonized as EN 61223-3-5:2004 (not modified)
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SIST EN IEC 62464-1:2019
EN IEC 62464-1:2019 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety
and essential performance
- - + corrigendum Mar. 2010
- - + A12 2014
+A1 2013 +A1 2013

IEC 60601-2-33 2010 Medical electrical equipment - Part 2-33: EN 60601-2-33 2010

Particular requirements for the basic
safety and essential performance of
magnetic resonance equipment for
medical diagnosis
- - + corrigendum Oct. 2010
- - + A11 2011
- - + A12 2016
IEC/TR 60788 - Medical electrical equipment - Glossary - -
of defined terms
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SIST EN IEC 62464-1:2019
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SIST EN IEC 62464-1:2019
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.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 62464-1:2019
– 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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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

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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

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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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SIST EN IEC 62464-1:2019
– 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: 12 ----------------------
SIST EN IEC 62464-1:2019
IEC 62464-1:2018 © IEC 2018 – 7 –
The text of this International Standard is based on the follow
...

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