EN 62464-1:2007
(Main)Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
This international standard specifies measurement procedures for the determination of many essential medical MR equipment image quality parameters. Measurement procedures as addressed in this standard are suitable for: - quality assessment in the acceptance test; - quality assurance in the constancy test. In addition, the measurement procedures specified in this standard may also be useful for type tests, although that is not an objective of this standard. The scope of this standard is also limited to measuring image quality characteristics in test devices, not in patient images. The measurement procedures specified in this standard are directed to: a) manufacturers, who can demonstrate compliance by performing acceptance and constancy methods as described by this standard, b) test houses, which can confirm performance of mr equipment using methods described in this standard, c) regulatory authorities, who can reference this standard, 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. 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
Appareils à résonance magnétique pour imagerie médicale - Partie 1: Détermination des principaux paramètres de qualité d’image
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
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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).
__________
- 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.
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.
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Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
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Pour prix, voir catalogue en vigueur
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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
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
62464-1 © IEC:2007 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING –
Part 1: Determination of essential image quality parameters
FOREWORD
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