SIST EN IEC 62464-1:2019

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

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

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)

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
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
– 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

IEC 62464-1:2018 © IEC 2018 – 3 –
4.6.5 Data analysis and tolerances . 35
4.6.6 Reporting of results . 35
4.6.7 Reporting of acceptance results . 36
4.7 * GHOSTING ARTEFACTS . 36
4.7.1 Objectives and rationale . 36
4.7.2 * Requirements for the TEST DEVICE . 36
4.7.3 Scan parameters . 36
4.7.4 Measurement procedure . 37
4.7.5 Data analysis and tolerances . 37
4.7.6 Reporting of results . 38
5 * CONSTANCY TEST . 39
5.1 Objectives and rationale . 39
5.2 Requirements for the TEST DEVICE . 39
5.3 Scan characteristics . 39
5.4 Measurement procedure . 39
5.5 Data analysis, reporting of results and tolerances . 40
Annex A (normative) Alternative methods . 41
A.1 Pertaining to 4.2 SIGNAL TO NOISE RATIO . 41
A.1.1 General . 41
A.1.2 Alternative method: SNR measurements using alternative noise
determination . 41
A.1.3 Alternative method: SNR "single image" . 42
A.2 Pertaining to 4.3 UNIFORMITY . 43
A.2.1 General . 43
A.2.2 Alternative method "grey-scale map" . 43
A.2.3 Alternative method "ACR method" . 45
A.3 Pertaining to 4.4SLICE THICKNESS in 2-D scanning . 45
A.3.1 General . 45
A.3.2 Alternative method: SLICE THICKNESS in 2-D scanning: wedge method . 46
A.4 Pertaining to 4.5 Two-dimensional GEOMETRIC DISTORTION . 48
A.4.1 General . 48
A.4.2 Alternative method: GEOMETRIC DISTORTION measurements using
elliptical boundary TEST DEVICES . 48
A.4.3 Alternative method: 3D GEOMETRIC DISTORTION component measurement
method . 49
A.5 Pertaining to 4.6 SPATIAL RESOLUTION . 56
A.5.1 General . 56
A.5.2 Alternative method: determination of the full MODULATION TRANSFER
FUNCTION . 57
A.6 Pertaining to 5 CONSTANCY TESTS . 58
A.6.1 Alternative CONSTANCY TEST methods . 58
A.6.2 Pitfalls . 61
Annex B (informative) Rationale . 62
B.1 Pertaining to 4 * Procedures for the determination of essential image
parameters . 62
B.2 Pertaining to 4.2 SIGNAL TO NOISE RATIO . 62
B.2.1 Rationale . 62
B.2.2 References . 75
B.3 Pertaining to 4.3 UNIFORMITY . 75
B.3.1 Rationale . 75

– 4 – IEC 62464-1:2018 © IEC 2018
B.3.2 AAD method . 75
B.3.3 Standing waves . 75
B.4 Pertaining to 4.5 Two-dimensional GEOMETRIC DISTORTION . 76
B.4.1 Rationale . 76
B.4.2 Pitfalls . 77
B.5 Pertaining to 4.6 SPATIAL RESOLUTION . 81
B.5.1 Rationale . 81
B.5.2 Pitfalls . 82
B.6 Pertaining to 4.7 GHOSTING ARTEFACTS . 83
B.6.1 Rationale . 83
B.6.2 Pitfalls . 83
B.6.3 References . 84
B.7 Pertaining to 5 CONSTANCY TEST – Rationale . 84
Index of defined terms . 86
Bibliography . 87

Figure 1 – Signal intensity profile in the inclined slab method . 25
Figure 2 – Correcting for rotation of TEST DEVICE . 27
Figure 3 – Example of a boundary wall TEST DEVICE for a spherical specification

volume with two lines passing through the centre . 29
Figure 4 – Example of a fiducial marker TEST DEVICE for a spherical specification
volume . 30
Figure 5 – Distances to be determined . 31
Figure 6 – Periodic pattern . 33
Figure 7 – Image of periodic pattern and position of ROI for coronal scans . 34
Figure 8 – Image of periodic pattern and position of ROI for transverse and sagittal
scans . 35
Figure 9 – Example image of the TEST DEVICE and region of interest (ROI) for signal,
ghost, and noise measurements. 38
Figure A.1 – Wedge TEST DEVICE . 46
Figure A.2 – Measurement of SLICE PROFILE and SLICE THICKNESS using wedge TEST
DEVICE. 47
Figure A.3 – Determination of radius length of an ellipse with semi axis length a and b
forming an angle α with respect to the X axis . 49
Figure A.4 – Possible TEST DEVICE configurations for measuring GEOMETRIC DISTORTION . 51
Figure A.5 – Two elements with an apparent spacing of A (x,y) but a true spacing of
i
T (x,y) . 53
i
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

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

– 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
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,
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in the subject dealt with may participate in this preparatory work. International, governmental and non-
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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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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.
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.
IEC 62464-1:2018 © IEC 2018 – 7 –
The text of this International Standard is based on the following documents:
CDV Report on voting
62B/1068/CDV 62B/1078/RVC
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
• requirements, compliance with which can be tested, and definitions: roman type;
• explanations, advice, notes, general statements and exceptions: smaller roman type;
• test specifications: italic type;
• TERMS DEFINED IN CLAUSE 3 OR IN OTHER INTERNATIONAL STANDARDS: SMALL CAPITALS.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex B.
A list of all the parts in the IEC 62464 series, published under the general title Magnetic
resonance equipment for medical imaging, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 8 – IEC 62464-1:2018 © IEC 2018
INTRODUCTION
This part of IEC 62464 is written at a moment in which the magnetic resonance (MR)
equipment is already present in the market place for more than 30 years. It is estimated that
more than 30 000 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 assessment of system
performance and system maintenance. It is therefore felt to be necessary to introduce this
document in addition to the existing standards on MR safety, because the IEC standards have
a true international character and this document combines current best practices together and
provides guidance on how to address the various questions on quality control and quality
assurance testing of MAGNETIC RESONANCE EQUIPMENT together. Having a standardised set of
test methods minimises 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 used for some time, this document 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
document. This objective is achieved by introducing preferred methods in the main text, while
allowing acceptable alternative test methods, described in Annex A. A number of the
ACCEPTANCE TEST methods described in this document are already described earlier, mainly
as NEMA technical MR standards, and new methods have been developed since then. For
this document, it is attempted to select the best method as preferred method, whereas for a
number of specific tests, good alternatives are available and are therefore also acceptable.
Also, for the quality assurance tests, 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 text. 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, TEST DEVICE design, and data analysis) and examples for
possible CONSTANCY TESTS for the required parameters in Annex A.
This document draws on the practical experiences gained in the implementation of
IEC 62464-1:2007 and benefits from the continued improvements found in the associated
updated NEMA MS series of standards. The utility in implementing the various tests found
herein was improved by clarifying the relationship between the tests, the parameters used,
the analysis of results, the expected calibration state of the scanner and the reporting of
results. Two tests, with no known sensitivity to, for example, field strength considerations
(SPATIAL RESOLUTION, SLICE THICKNESS in 2-D scanning), now have acceptance criteria. The
Annex A GEOMETRIC DISTORTION test suite now includes 3-D test methods.
An original goal of IEC 62464-1:2007 was linkage of the SNR, SLICE THICKNESS and resolution
tests in order to characterize the system in a consistent configuration. However, increasing
the range of B covered in this document from 4 T to 8 T (consistent with the recent changes
in IEC 60601-2-33) required additional flexibility in the TEST DEVICE filler composition in order
to eliminate confounding wavelength ARTEFACTS. Therefore, the various test clauses are
decoupled in this document. This permits the flexibility to perform each test in an optimal
configuration and does not require a retest of other parameters. For example, it is not
necessary to repeat a resolution test for a RF COIL, which is not a function of the RF COIL,
when the objective is to measure only SNR.
It was not possible to establish a full set of TEST DEVICE and scan parameter requirements
appropriate for all MRI systems at the full range of B permitted in this document. Instead, this
document was modified to state that testing shall be performed in an MRI system that has
been properly calibrated for routine clinical scanning. Calibration is specific to the make and
model of MRI scanner and no requirements are listed in this document.The flexibility in the

IEC 62464-1:2018 © IEC 2018 – 9 –
definition of specification areas and volumes was improved to support the increasing
specialization of receive coils. The standard encourages reuse of phantoms for multiple
applications where possible, as long as the phantom provides signal in the specification area
and/or volume as required, unless instructed otherwise.
This document has also been modified regarding the use of reconstruction and image filters.
The intent of IEC 62464-1:2007 was to disable all user controlled filters, and record the
condition of all other filters, in order to characterize the system in the most basic possible
configuration. However, systems continue to evolve and the presence and configuration of
some filters are not known to the end user (e.g. image reconstruction), whereas other filters
might be known to the end user, beyond their control, and always applied (e.g. GEOMETRIC
DISTORTION correction). This document formally introduces two mechanisms for addressing
this situation: 1) the concept of "clinically relevant" to provide guidance on filter settings and
2) an emphasis on the accurate recording of all parameters used in the acquisition and
reconstruction of the images sufficient to enable a faithful reproduction of results on another
unit of the same make, model and software revision. The intent of "clinically relevant" is to
enable a known and properly identified protocol from a given software revision to be used as
the basis for the tests. Factory set defaults are assumed to be applied, and filters considered
not essential can be turned on or off as clinically appropriate. All adjustments made from
default setting should be recorded in the reporting of results. By carefully recording the base
system configuration and any additional acquisition parameter adjustments, all known and
unknown filter settings are reproducible and all results should be repeatable. Note that
"clinically relevant" also enables the user of this document to appropriately select parameters
(e.g. acquisition bandwidth) that may vary with B or other system attributes.
– 10 – IEC 62464-1:2018 © IEC 2018
MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING –

Part 1: Determination of essential image quality parameters

1 Scope
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

IEC 62464-1:2018 © IEC 2018 – 11 –
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.
2 Normative references
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.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2013
IEC 60601-2-33:2010, Medical electrical equipment – Part 2-33: Particular requirements for
the basic safety and essential performance of magnetic resonance equipment for medical
diagnosis
IEC TR 60788, Medical electrical equipment – Glossary of defined terms
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-2-33, IEC TR 60788 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE 1 See also the IEC Glossary available at http://std.iec.ch/glossary.
NOTE 2 An index of defined terms is found beginning on page 86.

– 12 – IEC 62464-1:2018 © IEC 2018
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
[SOURCE: IEC 61223-3-5:2004, 3.1]
3.1.2
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
3.1.3
BANDWIDTH PER PIXEL
BPP
reciprocal of the duration of the sampling window
Note 1 to entry: Instead of BANDWIDTH PER PIXEL, alternate values may be stated on the control console in a
MANUFACTURER-specific format. For a rationale on how to convert the MANUFACTURER-specific information into the
required BANDWIDTH PER PIXEL, see B.2.1.5.
Note 2 to entry: This definition is only applicable when standard, constant-gradient readout is used.
Note 3 to entry: This note applies to the French text only.
3.1.4
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
[SOURCE: IEC 61223-3-5:2004, 3.2]
3.1.5
EDGE SPREAD FUNCTION
ESF
discrete profile of the image data, taken across a sharp edge
Note 1 to entry: This note appl
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