SIST EN 62464-1:2010
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters (IEC 62464-1:2007)
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters (IEC 62464-1:2007)
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. 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 otherwise stated; - image quality affected by MR-compatibility issues; - special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications; - type tests. 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, and d) 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. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. 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.
Magnetresonanzgeräte für die medizinische Bildgebung - Teil 1: Bestimmung der wesentlichen Bildqualitätsparameter (IEC 62464-1:2007)
Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des principaux paramètres de qualité d’image (CEI 62464-1:2007)
La présente Norme internationale spécifie des procédures de mesure pour la détermination de nombreux paramètres essentiels de la qualité d'image des appareils à résonance magnétique à usage médical. Les procédures de mesure développées dans la présente norme conviennent pour:
- l'évaluation de la qualité dans le cadre de l'essai d'acceptation;
- l'assurance qualité dans le cadre de l'essai de constance.
En outre, les procédures de mesure spécifiées dans la présente norme peuvent également s'avérer utiles pour des essais de type même s'il ne s'agit pas d'un objectif de la présente norme.
Le domaine d'application de la présente norme se limite également à la mesure des caractéristiques de la qualité d'image des dispositifs d'essai et non des patients.
Les procédures de mesure spécifiées dans la présente norme s'adressent:
a) auxfabricants qui peuvent démontrer la conformité de leurs appareils par des méthodes d'essai d'acceptation et de constance telles que décrites dans la présente norme,
b) aux laboratoires d'essai qui peuvent ainsi confirmer les performances d'appareils à résonance magnétique au moyen de méthodes décrites dans la présente norme,
c) aux autorités de réglementation qui peuvent faire référence à la présente norme, et
d) aux organismes responsables qui souhaitent effectuer des essais d'acceptation et de constance sur la base des méthodes décrites dans la présente norme.
Les principaux paramètres de qualité d'image et les méthodologies de mesures définis dans la présente norme sont les suivants:
- le rapport signal/bruit,
- l'uniformité,
- l'épaisseur et le profil de coupe,
- la distorsion géométrique,
- la résolution spatiale, et
- les fausses images.
La présente norme décrit les procédures de mesure préférentielles. D'autres méthodes sont également décrites à l'Annexe A. Les méthodes d'essai préférentielles peuvent être remplacées par des méthodes alternatives. Si nécessaire, d'autres méthodes qui ne sont pas décrites dans la présente norme peuvent être utilisées à condition que ces autres méthodes soient documentées et validées par rapport aux méthodes décrites dans la norme. La validation d'autres méthodes d'essai nécessite une analyse de la sensibilité de l'essai au même paramètre d'intérêt ainsi qu'une analyse de l'insensibilité de l'essai à d'autres paramètres non pertinents; il convient à cet égard de démontrer un niveau de sensibilité similaire ou supérieur à ce même paramètre d'intérêt et un niveau de robustesse similaire ou supérieur aux paramètres non pertinents. Toutes les méthodes doivent produire des résultats quantitatifs.
La présente norme 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. Il n'est pas donné de méthodes préférentielles d'essai de constance afin de préserver la souplesse d'utilisation des procédures automatisées éventuellement existantes; cependant, l'Annexe A suggère des exemples de méthodes d'essai. Il est admis, si nécessaire, d'utiliser d'autres méthodes d'essai de constance non décrites dans la présente norme. Du fait de la diversité des besoins des programmes d'assurance qualité des différents organismes responsables, ces derniers sont encouragés à déterminer la portée nécessaire des essais, de leur qualité et de la sensibilité de l'analyse de données, etc. La présente norme met l'accent sur des outils de mesure automatisés, continu
Oprema za magnetno resonanco za medicinsko slikanje - 1. del: Ugotavljanje bistvenih parametrov za kakovost slike (IEC 62464-1:2007)
Ta mednarodni standard določa merilne postopke za ugotavljanje številnih bistvenih parametrov kakovosti slike MR OPREME. Merilni postopki, obravnavani v tem standardu, so primerni za: - ocenjevanje kakovosti pri PRESKUSU SPREJEMLJIVOSTI; - zagotavljanje kakovosti pri PRESKUSU KONSTANTNOSTI. Poleg tega je postopek merjenja, določen v tem standardu, lahko uporaben tudi za tipske preskuse, čeprav to ni cilj tega standarda. Ta standard ne obravnava: - zahtevane stopnje zmogljivosti za PRESKUS SPREJEMLJIVOSTI in PRESKUS KONSTANTNOSTI; - ocene kakovosti slike MR OPREME z visokim poljem, večjim od 4 T, če ni drugače navedeno; - kakovosti slike, na katero vplivajo zadeve, povezane z združljivostjo MR; - posebnih diagnostičnih postopkov, kot so tokovne slike, perfuzijsko in difuzijsko slikanje, radioterapija ter slikovno vodene terapijske uporabe; tipski preskusi. Področje uporabe tega standarda je omejeno tudi na značilnosti merjenja kakovosti slike v PRESKUSNIH NAPRAVAH in ne slikah PACIENTOV. Postopki merjenje, določeni v tem standardu, so namenjeni: a) PROIZVAJALCEM, ki lahko izkažejo skladnost z izvajanjem metod sprejemljivosti konstantnosti, kot jih opisuje ta standard, b) laboratorijem, ki lahko potrdijo zmogljivost MR opreme z uporabo metod, opisanih v tem standardu, c) regulativnim organom, ki lahko priporočijo ta standard, in d) PRISTOJNIM ORGANIZACIJAM, ki želijo izvesti PRESKUSE SPREJEMLJIVOSTI in KONSTANTNOSTI z uporabo metod, opisanih v tem standardu. Ključni parametri in metodologije merjenja kakovosti slike, opredeljeni v tem standardu, so: - RAZMERJE MED SIGNALOM IN HRUPOM, - ENAKOST, - DEBELINA REŽNJA in PROFIL REŽNJA, GEOMETRIČNO IZKRIVLJANJE, PROSTORSKA RESOLUCIJA in napačno prikazovanje. Ta mednarodni standard opisuje prednostne merilne postopke. Prav tako opisuje alternativne metode v Dodatku A. Prednostne preskusne metode se lahko nadomestijo z alternativnimi metodami. Kadar je to potrebno, se lahko uporabijo druge metode, ki niso opisane v tem standardu, pod pogojem, da so te druge preskusne metode dokumentirane in potrjene z metodami, opisanimi v standardu. Potrjevanje drugih preskusnim metod zahteva analizo občutljivosti preskusa na iste aktualne parametre in analizo neobčutljivosti preskusa na druge, nepovezane parametre, ter bi moralo izkazati podobno ali višjo raven občutljivosti na iste aktualne parametre ter podobno ali višjo raven stabilnosti glede na nepovezane parametre. Vse metode bi morale doseči kvantitativne rezultate. Utemeljitev prednostnih in alternativnih metod ter njihove pasti so opisane v Dodatku B. Ta standard tudi predstavlja zahteve za PRESKUSE KONSTANTNOSTI, primerne za programe zagotavljanja kakovosti MP OPREME, ki zadevajo bistvene parametre kakovosti slike. Prednostne metode PRESKUSA KONSTANTNOSTI ne obstajajo zaradi zagotavljanja fleksibilnosti pri uporabi obstoječih avtomatskih postopkov, kjer so na voljo, vendar se predlagani primeri preskusnih metod nahajajo v Dodatku A. Če je potrebno, se lahko uporabijo druge metode PRESKUSA KONSTANTNOSTI, ki niso opisane v tem standardu. Ker se potrebe programov PRISTOJNIH ORGANIZACIJ za zagotavljanje kakovosti lahko razlikujejo, se PRISTOJEN ORGANIZACIJE spodbuja k določevanju potrebnega področja uporabe preskusov, kakovosti preskusov in občutljivosti analize podatkov ter itd. Ta standard poudarja konsistentno ponavljajoča, avtomatska merilna orodja, ki olajšujejo analizo trenda in pogosto hitro preskušanje majhnih nizov pomembnih parametrov, ki so občutljivi na splošne značilnosti delovanja MR OPREME.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 62464-1:2010
01-september-2010
Oprema za magnetno resonanco za medicinsko slikanje - 1. del: Ugotavljanje
bistvenih parametrov za kakovost slike (IEC 62464-1:2007)
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential
image quality parameters (IEC 62464-1:2007)
Magnetresonanzgeräte für die medizinische Bildgebung - Teil 1: Bestimmung der
wesentlichen Bildqualitätsparameter (IEC 62464-1:2007)
Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des
principaux paramètres de qualité d’image (CEI 62464-1:2007)
Ta slovenski standard je istoveten z: EN 62464-1:2007
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 62464-1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 62464-1:2010
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SIST EN 62464-1:2010
EUROPEAN STANDARD
EN 62464-1
NORME EUROPÉENNE
May 2007
EUROPÄISCHE NORM
ICS 11.040.50
English version
Magnetic resonance equipment for medical imaging -
Part 1: Determination of essential image quality parameters
(IEC 62464-1:2007)
Appareils à résonance magnétique Magnetresonanzgeräte
pour imagerie médicale - für die medizinische Bildgebung -
Partie 1: Détermination des principaux Teil 1: Bestimmung der wesentlichen
paramètres de qualité d’image Bildqualitätsparameter
(IEC 62464-1:2007)
(CEI 62464-1:2007)
This European Standard was approved by CENELEC on 2007-04-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62464-1:2007 E
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SIST EN 62464-1:2010
EN 62464-1:2007 - 2 -
Foreword
The text of document 62B/641/FDIS, future edition 1 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 was approved by CENELEC as EN 62464-1 on 2007-04-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-04-01
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications: italic type;
– terms defined in Clause 3 of EN 60601-1:2006, in this standard or in IEC/TR 60788: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62464-1:2007 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-1 NOTE Harmonized as EN 60601-1:2006 (not modified).
IEC 60601-1-2 NOTE Harmonized as EN 60601-1-2:2001 (not modified).
IEC 60601-2-33 NOTE Harmonized as EN 60601-2-33:2002 (not modified).
IEC 61223-2-6 NOTE Harmonized as EN 61223-2-6:2007 (not modified).
__________
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SIST EN 62464-1:2010
- 3 - EN 62464-1:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application 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 When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
1)
IEC/TR 60788 - Medical electrical equipment - Glossary of - -
defined terms
1)
Undated reference.
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SIST EN 62464-1:2010
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SIST EN 62464-1:2010
NORME CEI
INTERNATIONALE
IEC
62464-1
INTERNATIONAL
Première édition
STANDARD
First edition
2007-01
Appareils à résonance magnétique
pour imagerie médicale –
Partie 1:
Détermination des principaux paramètres
de qualité d'image
Magnetic resonance equipment
for medical imaging –
Part 1: Determination of essential image
quality parameters
© IEC 2007 Droits de reproduction réservés ⎯ Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
XC
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11
1 Scope.13
2 Normative references .15
3 Terms, definitions and symbols .15
3.1 Terms and definitions .15
3.2 Symbols .23
4 Procedures for the determination of essential image parameters .35
4.1 General requirements for all procedures.35
4.2 SIGNAL TO NOISE RATIO .37
4.3 UNIFORMITY.43
4.4 SLICE THICKNESS in 2-D scanning .49
4.5 Two-dimensional GEOMETRIC DISTORTION.59
4.6 SPATIAL RESOLUTION.67
4.7 GHOSTING ARTEFACTS .73
5 CONSTANCY TEST.79
5.1 Objectives and rational.79
5.2 Requirements for the TEST DEVICE.81
5.3 Scan characteristics .81
5.4 Measurement procedure.81
5.5 Data analysis, reporting of results and tolerances .83
Annex A (normative) Alternative methods .85
Annex B (informative) Rationales.113
Bibliography.150
Index of defined terms .155
Figure 1 – Insertion of a homogenous TEST DEVICE into the RF COIL .45
Figure 2 – Position of the TEST DEVICE on the surface coil .45
Figure 3 – Signal intensity profile in the inclined slab method .51
Figure 4 – Correcting for rotation of TEST DEVICE .55
Figure 5 – TEST DEVICE example for a spherical SPECIFICATION VOLUME, consisting of a
polypropylene carboy (Perspex) cylinder whose internal wall defines the ROI perimeter .61
Figure 6 – TEST DEVICE example for a spherical SPECIFICATION VOLUME, consisting of a
number of vials distributed on the ROI perimeter.61
Figure 7 – Two lines passing through the centre of the TEST DEVICE .63
Figure 8 – Distances to be determined.65
Figure 9 – Periodic pattern.69
Figure 10 – Image of periodic pattern and position of ROI.71
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 5 –
Figure 11 – TEST DEVICE (circular object), ghosts (crescents),
and REGION OF INTEREST (ROI) measurement boxes for mean signal, ghost,
and noise measurements .77
Figure A.1 – Wedge TEST DEVICE.95
Figure A.2 – Measurement of SLICE PROFILE and SLICE THICKNESS using wedge TEST
DEVICE .97
Figure B.1 – Relaxation times T and T in dependency on the
1 2
concentration of CuSO × 5 H 0 .117
4 2
Figure B.2 – Centring error .137
Table B.1 – TEST DEVICE conductivity and dielectric properties. 121
Table B.2 – Comparison of company bandwidths .129
Table B.3 – Relaxation fit parameters for Gd[TMHD] concentrations ≤4 parts per
thousand by weight.131
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING –
Part 1: Determination of essential image quality parameters
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62464-1 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/641/FDIS 62B/646/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 9 –
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications: italic type;
– terms defined in clause 2 of the General Standard, in this standard or in IEC 60788:
SMALL CAPITALS
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 11 –
INTRODUCTION
This international standard is written at a moment in which MAGNETIC RESONANCE EQUIPMENT is
already present in the market place for more than 20 years. It is estimated that more then
20 000 scanners are operational and more than 0,5 billion PATIENTS have been scanned. A
number of standards on quality assurance and quality control have been developed by
national committees to address the need for quantitative addressing of system performance
and system maintenance. It is therefore felt to be necessary to introduce this IEC standard in
addition to the existing standard on MAGNETIC RESONANCE (MR) safety, because the IEC
standards have a true international character and this IEC standard is the first start to process
and combine current best practices together and provide guidance on how to address the
various questions on quality control and quality assurance testing of MAGNETIC RESONANCE
EQUIPMENT together. Having a standardized set of test methods minimizes the amount of work
for the MR MANUFACTURERS to demonstrate the performance characteristics of the MR
scanners for many different countries and in addition, these countries do not have to
formulate their own requirements for the performance testing.
Since MR scanners have been around for some time, this international standard is an attempt
to consolidate the current way of working for the quality control of the performance
characteristics concerning essential image quality parameters, and does not introduce major
new development efforts for the established MR equipment to fulfil the requirements of this
standard. This objective is achieved by introducing preferred methods in the main text of the
standard, while allowing acceptable alternative test methods, described in Annex A of the
standard. A number of the ACCEPTANCE TEST methods described in the standard have already
been described earlier, mainly as NEMA technical MR standards, while new methods have
been developed since then. For this standard, it is attempted to select the best method as the
preferred method, although for a number of specific tests good alternatives are available and
are therefore also acceptable.
Also for the quality assurance tests and the CONSTANCY TESTS, each MANUFACTURER has
developed its own test device and related test procedures and data analysis in the past years.
For the CONSTANCY TESTS it was therefore decided not to describe detailed test methods but
only prescribe the parameters to be measured and essential conditions for these
measurements in the main standard. This provides the necessary latitude to account for the
many unique MR designs (extremity scanners, whole body scanners, cylindrical versus open
scanners, various field strengths, phantom design, data analysis) and examples for possible
CONSTANCY TESTS for the required parameters in the annex. This allows the user to use as
many of the tools supplied by MR MANUFACTURERS as possible, appropriate and useful and
still fulfill the requirements for quality control and quality assurance.
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SIST EN 62464-1:2010
62464-1 © IEC:2007 – 13 –
MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING –
Part 1: Determination of essential image quality parameters
1 Scope
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.
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 otherwise
stated;
- image quality affected by MR-compatibility issues;
- special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and
image-guided therapy applications;
- type tests.
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, and
d) 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.
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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.
The rationale to the preferred and alternate methods, and their pitfalls, are described in
Annex B.
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.
2 Normative references
The following referenced documents are indispensable for the application 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.
IEC 60788, Medical electrical equipment – Glossary of defined terms
3 Terms, definitions and symbols
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1.1
acceptance test
test carried out after new EQUIPMENT has been installed, or major modifications have been
made to existing EQUIPMENT, in order to verify compliance with contractual specifications
[IEC 61223-1, definition 3.2.4]
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3.1.2
accompanying document
document accompanying ME EQUIPMENT, an ME SYSTEM, EQUIPMENT or an ACCESSORY and
containing information for the RESPONSIBLE ORGANIZATION or OPERATOR, particularly regarding
BASIC SAFETY and ESSENTIAL PERFORMANCE
[IEC 60601-1:2005, definition 3.4]
3.1.3
artefact
apparent structure visible in the image that does not represent a structure at the
corresponding position within the object and that cannot be explained by noise
3.1.4
bandwidth per pixel
reciprocal of the duration of the sampling window
NOTE Instead of BANDWIDTH PER PIXEL, equivalent values may be stated on the control console.
3.1.5
body test device
TEST DEVICE representing the PATIENT’S body
3.1.6
constancy test
each of a series of tests, carried out:
– to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA; or
– to enable the early recognition of changes in the properties of components of the
EQUIPMENT.
[IEC 61223-1:1993, definition 3.2.6]
3.1.7
extremity test device
TEST DEVICE representing the PATIENT’s extremities
3.1.8
field of view
FOV
size of the imaging area requested by OPERATOR
NOTE To be specified with one or two linear measures (in mm), if imaging area is square or rectangular
respectively.
3.1.9
geometric distortion
spatial position deviation of the imaged structure from expected position of real object
structure
3.1.10
ghosting artefact
ARTEFACT showing a replica or part of the replica of an existing structure in a wrong position
3.1.11
head test device
TEST DEVICE representing the PATIENT’s head
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3.1.12
image data
reconstructed acquisition data
3.1.13
image noise
random fluctuations from the expected signal values in an image
3.1.14
intended use/intended purpose
use of a product, process or service in accordance with the specifications, instructions and
information provided by the MANUFACTURER
[IEC 60601-1:2005, definition 3.44]
3.1.15
isocentre
in MR EQUIPMENT null point of the spatially encoding gradients
NOTE Typically, this also corresponds to the region of highest magnet homogeneity.
3.1.16
magnetic resonance equipment
MR equipment
MEDICAL ELECTRICAL EQUIPMENT that is intended for in-vivo MAGNETIC RESONANCE EXAMINATION
of a PATIENT. The MR EQUIPMENT comprises all parts in hardware and software from the SUPPLY
to the display monitor. The MR EQUIPMENT is a Programmable Electrical Medical System
MAINS
(PEMS)
[IEC 60601-2-33:2002, definition 2.2.101]
3.1.17
magnetic resonance system
MR system
ensemble of MR EQUIPMENT, ACCESSORIES including means for display, control, energy
supplies, and the CONTROLLED ACCESS AREA, where provided
[IEC 60601-2-33:2002, definition 2.2.102]
3.1.18
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling
of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM,
regardless of whether these operations are performed by that person or on that person's
behalf by a third party
[IEC 60601-1:2005, definition 3.55]
3.1.19
operator
person handling EQUIPMENT
[IEC 60601-1:2005, definition 3.73]
3.1.20
radio frequency coil
RF coil
coil or probe used to transmit and/or receive radio frequency electromagnetic fields
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3.1.21
reconstruction parameters
in MR EQUIPMENT ensemble of all parameters that uniquely define the transform of the digitized
signals to an image
3.1.22
reference position
predefined point within the SPECIFICATION VOLUME
NOTE Normally the REFERENCE POSITION lies on the symmetry axis of the coil and corresponds to the centre of
gravity of the SPECIFICATION VOLUME.
3.1.23
region of interest
ROI
localized part of an image, which is of particular interest at a given time
[IEC 61223-2-6, definition 3.3.9]
3.1.24
responsible organisation
entity accountable for the use and maintenance of an ME EQUIPMENT or an ME SYSTEM
NOTE 1 The accountable entity can be, for example, a hospital, an individua
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