SIST EN IEC 61223-3-5:2020

SLOVENSKI STANDARD
SIST EN IEC 61223-3-5:2020
01-januar-2020
Nadomešča:
SIST EN 61223-2-6:2010
SIST EN 61223-3-5:2005
Ovrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-5. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
računalniško podprto tomografijo (IEC 61223-3-5:2019)
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance
tests and constancy tests - Imaging performance of computed tomography X-ray
equipment (IEC 61223-3-5:2019)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-5: Abnahmeprüfungen - Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen
für Computertomographie (IEC 61223-3-5:2019)
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-5:
Essais d'acceptation et de constance - Performance d'imagerie des équipements de
tomodensitométrie à rayonnement X (IEC 61223-3-5:2019)
Ta slovenski standard je istoveten z: EN IEC 61223-3-5:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN IEC 61223-3-5:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61223-3-5:2020

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SIST EN IEC 61223-3-5:2020


EUROPEAN STANDARD EN IEC 61223-3-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2019
ICS 11.040.50 Supersedes EN 61223-3-5:2004 and all of its
amendments and corrigenda (if any)
English Version
Evaluation and routine testing in medical imaging departments -
Part 3-5: Acceptance tests and and constancy tests - Imaging
performance of computed tomography X-ray equipment
(IEC 61223-3-5:2019)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-5: Essais d'acceptation et de medizinische Bildgebung - Teil 3-5: Abnahmeprüfungen -
constance - Performance d'imagerie des équipements de Leistungsmerkmale zur Bildgebung von
tomodensitométrie à rayonnement X Röntgeneinrichtungen für Computertomographie
(IEC 61223-3-5:2019) (IEC 61223-3-5:2019)
This European Standard was approved by CENELEC on 2019-10-21. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, 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 61223-3-5:2019 E

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SIST EN IEC 61223-3-5:2020
EN IEC 61223-3-5:2019 (E)
European foreword
The text of document 62B/1134/FDIS, future edition 2 of IEC 61223-3-5, 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 61223-3-5:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-07-21
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-10-21
document have to be withdrawn

This document supersedes EN 61223-3-5:2004 and all of its amendments and corrigenda (if any).
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 61223-3-5:2019 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 61674:2012 NOTE Harmonized as EN 61674:2013 (not modified)


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SIST EN IEC 61223-3-5:2020
EN IEC 61223-3-5:2019 (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
+ A1 2012  + A1 2013
- -  + A12 2014
IEC 60601-2-44 2009 Medical electrical equipment - Part 2-44: EN 60601-2-44 2009
Particular requirements for the basic safety
and essential performance of X-ray
equipment for computed tomography
- -  + A11 2011
+ A1 2012  + A1 2012
+ A2 2016  + A2 2016
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

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SIST EN IEC 61223-3-5:2020



IEC 61223-3-5

®


Edition 2.0 2019-09




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Evaluation and routine testing in medical imaging departments –

Part 3-5: Acceptance and constancy tests – Imaging performance of computed

tomography X-ray equipment




Essais d'évaluation et de routine dans les services d'imagerie médicale –

Partie 3-5: Essais d'acceptation et de constance – Performance d'imagerie des


équipements de tomodensitométrie à rayonnement X













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.50 ISBN 978-2-8322-7280-0




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 61223-3-5:2020
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CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope and object . 8
2 Normative references . 9
3 Terms and definitions . 9
4 General aspects of ACCEPTANCE TESTS and CONSTANCY TESTS . 17
4.1 General conditions to be considered in test procedures . 17
4.1.1 General . 17
4.1.2 Preconditions . 18
4.1.3 BASELINE VALUES . 18
4.1.4 Identification and recording of equipment, instrumentation, and test
conditions . 18
4.1.5 TEST DEVICES . 18
4.2 Documents and data for the tests in the ACCOMPANYING DOCUMENTS . 19
4.3 Scope of tests . 20
4.4 Considerations for selection of ACCEPTANCE and CONSTANCY TESTS . 20
4.5 Measuring equipment . 21
4.6 Actions to be taken after a MAJOR SERVICE ACTION . 21
4.7 Establishment of BASELINE VALUES . 21
4.8 Frequency of CONSTANCY TESTS . 22
5 Test methods for CT SCANNERS . 22
5.1 Positioning of the PATIENT SUPPORT . 22
5.1.1 Summary . 22
5.1.2 Test equipment . 22
5.1.3 Test procedure . 22
5.1.4 Data evaluation . 23
5.1.5 Criteria to be applied . 23
5.1.6 Constancy testing . 23
5.2 PATIENT positioning accuracy . 24
5.2.1 Axial PATIENT positioning accuracy . 24
5.2.2 Sagittal and coronal PATIENT positioning light accuracy (if available) . 25
5.2.3 Constancy testing – Axial, sagittal, and coronal positioning light
accuracy . 25
5.3 RECONSTRUCTED SECTION THICKNESS . 26
5.3.1 General . 26
5.3.2 RECONSTRUCTED SECTION THICKNESS for axial scanning . 26
5.3.3 RECONSTRUCTED SECTION THICKNESS for helical scanning . 28
5.4 Dose . 28
5.4.1 Summary . 28
5.4.2 Test equipment . 28
5.4.3 Test procedure . 28
5.4.4 Data evaluation . 29
5.4.5 Criteria to be applied . 30
5.4.6 Constancy testing . 30
5.5 MEAN CT NUMBER, magnitude of NOISE, and UNIFORMITY . 31
5.5.1 Summary . 31
5.5.2 Test equipment . 32

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5.5.3 Test procedure . 32
5.5.4 Scan conditions . 32
5.5.5 Criteria to be applied for ACCEPTANCE TEST . 35
5.5.6 Criteria to be applied for CONSTANCY TESTS . 36
5.6 SPATIAL RESOLUTION (high contrast) . 38
5.6.1 Summary . 38
5.6.2 Information to be supplied in the ACCOMPANYING DOCUMENTS . 38
5.6.3 Test equipment . 38
5.6.4 Test procedure . 38
5.6.5 Data evaluation . 39
5.6.6 Criteria to be applied . 39
5.6.7 Constancy testing . 39
5.7 Automatic exposure control (AEC) . 39
5.8 LOW CONTRAST RESOLUTION and LOW CONTRAST DETECTABILITY . 40
Annex A (informative) Visual method for LOW CONTRAST RESOLUTION . 41
Annex B (informative) DOSE PROFILE . 42
B.1 Summary . 42
B.2 Methods . 42
B.2.1 Point dosimeter method . 42
B.2.2 Film method . 42
B.2.3 Criteria to be applied . 42
Annex C (informative) Accuracy of the gantry tilt . 43
C.1 Summary . 43
C.2 Method A . 43
C.2.1 Test equipment . 43
C.2.2 Test procedure . 43
C.2.3 Data evaluation . 43
C.2.4 Criteria to be applied . 43
C.3 Method B . 44
C.3.1 Test equipment . 44
C.3.2 Test procedure . 44
C.3.3 Data evaluation . 44
C.4 Criteria to be applied. 44
Annex D (informative) Characterization of z-axis SPATIAL RESOLUTION . 45
Annex E (informative) Helical RECONSTRUCTED SECTION THICKNESS . 46
E.1 Summary . 46
E.2 Test equipment . 46
E.3 Test procedure . 46
E.4 Data evaluation . 46
Annex F (informative) Guidance on action to be taken . 47
F.1 Failing the ESTABLISHED CRITERIA at first measurement . 47
F.2 Failing the ESTABLISHED CRITERIA after repeated measurement . 47
F.3 Marginally failing the ESTABLISHED CRITERIA . 47
F.4 Substantially failing the ESTABLISHED CRITERIA . 47
F.5 History of repeatedly failing the ESTABLISHED CRITERIA . 48
F.6 Failing the established CONSTANCY CRITERIA but passing the established
ACCEPTANCE CRITERIA . 48
F.7 Cases not covered by Clauses F.1 to F.5 . 48

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Annex G (informative) Automated exposure control (AEC) . 49
G.1 Overview. 49
G.2 Test equipment . 49
G.3 Test procedure . 49
G.4 Size-dependent modulation evaluation . 49
G.4.1 Size-dependent modulation evaluation for Adult Body PROTOCOL
ELEMENTS . 49
G.4.2 Size-dependent modulation evaluation for Paediatric Body PROTOCOL
ELEMENTS . 50
G.5 Longitudinal modulation evaluation . 50
G.6 Data evaluation . 51
G.6.1 Size-dependent modulation evaluation . 51
G.6.2 Longitudinal modulation evaluation . 51
G.7 Criteria to be applied. 51
G.7.1 Size-dependent modulation evaluation . 51
G.7.2 Longitudinal modulation evaluation . 51
Annex H (informative) Mapping of IEC requirements to regulations . 52
Annex I (informative) Overview of criteria for acceptance and constancy testing for 5.5 . 54
Annex J (informative) Overview of criteria and frequency for all acceptance and
constancy testing . 55
Bibliography . 59
Index of defined terms . 60

Figure 1 – Coordinate system . 14
Figure 2 – Illustration of N × T, R and (N × T) + R . 16
Figure G.1 – TEST DEVICE aligned . 50

Table 1 – Test pattern for CTDI for Adult Body PROTOCOL ELEMENTS . 29
free air
Table 2 – Combination of PROTOCOL ELEMENTS and PHANTOMS used for ACCEPTANCE
TEST scans . 33
Table 3 – Combination of PROTOCOL ELEMENTS and PHANTOMS used for CONSTANCY
TEST scans . 33
Table H.1 – Mapping of IEC requirements to regulations . 52
Table I.1 – Overview of criteria for ACCEPTANCE and CONSTANCY TESTING for 5.5 . 54
Table J.1 –Overview of criteria and frequency . 55

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SIST EN IEC 61223-3-5:2020
IEC 61223-3-5:2019 © IEC 2019 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

EVALUATION AND ROUTINE TESTING IN
MEDICAL IMAGING DEPARTMENTS –

Part 3-5: Acceptance and constancy tests – Imaging
performance of computed tomography X-ray equipment

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 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 61223-3-5 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 2004, and the second
edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition and to IEC 61223-2-6:
a) modification of the RADIATION protection and control;
b) modification of the acceptance testing;
c) introduction of constancy testing.

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The text of this International Standard is based on the following documents:
FDIS Report on voting
62B/1134/FDIS 62B/1145/RVD

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: in roman type;
explanations, advice, notes, general statements, exceptions and references: in smaller type;
•
• test specifications: in italic type;
• TERMS USED THROUGHOUT THIS DOCUMENT THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED
TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS.
A list of all parts in the IEC 61223 series, published under the general title Evaluation and
routine testing in medical imaging departments, 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.
NOTE The attention of the users of this document is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

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IEC 61223-3-5:2019 © IEC 2019 – 7 –
INTRODUCTION
This part of IEC 61223 gives methods for acceptance testing and constancy testing for
medical diagnostic CT equipment.
The complete set of ACCEPTANCE TESTS is to be carried out after new equipment has been
installed, or a subset of the tests is to be carried out after each MAJOR SERVICE ACTION that is
made to existing equipment. This is done in order to facilitate verification of applicable safety
and performance standards, regulations, and published and/or contractual specifications that
influence the image quality, RADIATION OUTPUT and PATIENT positioning.
To maintain the homogeneity of this document with the other IEC standards addressing
CT SCANNERS, the measuring methods and the terminology are taken as applicable from the
CT safety standard IEC 60601-2-44:2009, IEC 60601-2-4
...