EN IEC 61223-3-5:2019

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment

IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3, • defines the methods of testing the essential parameters, and • evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to • aspects of mechanical and electrical safety, and • aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning. IEC 61223-3-5:2019 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: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing.

Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-5: Abnahmeprüfungen - Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen für Computertomographie

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

L'IEC 61223-3-5:2019 s'applique aux TOMODENSITOMETRES, qui sont conformes à l'IEC 60601-2-44:2009, l'IEC 60601-2-44:2009/AMD1:2012 et l'IEC 60601 2 44:2009/AMD1:2012AMD2:2016. L'IEC 60601-2-44 et le présent document: • définissent les paramètres importants qui décrivent les performances des TOMODENSITOMETRES en ce qui concerne la qualité d'image, la PUISSANCE DE RAYONNEMENT et le positionnement du PATIENT; la liste des paramètres à soumettre à l'essai est fournie en 4.3; • définissent les méthodes d'essai des paramètres importants; et • évaluent la conformité des paramètres par rapport aux tolérances SPECIFIEES dans les DOCUMENTS D'ACCOMPAGNEMENT. Les méthodes définies dans l'IEC 60601-2-44 et le présent document s'appuient sur des mesures non invasives, exécutées pendant ou après l'installation, en utilisant des équipements d'essai adéquats. Des déclarations signées couvrant des étapes de la procédure d'installation peuvent être utilisées dans le cadre du rapport d'ESSAI D'ACCEPTATION. Le présent document s'applique aux ESSAIS D'ACCEPTATION et aux ESSAIS DE CONSTANCE destinés à un TOMODENSITOMETRE. L'objet des ESSAIS D'ACCEPTATION est de vérifier la conformité de l'installation ou d'une OPERATION DE MAINTENANCE IMPORTANTE aux spécifications concernant la qualité de l'image, la PUISSANCE DE RAYONNEMENT et le positionnement du PATIENT. L'objet des ESSAIS DE CONSTANCE est de s'assurer que les performances fonctionnelles de l'APPAREIL satisfont aux CRITÈRES ÉTABLIS et de permettre l'identification précoce des modifications des propriétés des composants de l'APPAREIL, mais également de vérifier la conformité aux spécifications concernant la qualité de l'image, la PUISSANCE DE RAYONNEMENT et le positionnement du PATIENT. Le présent document contient également les exigences associées aux ESSAIS D'ACCEPTATION et aux ESSAIS DE CONSTANCE en ce qui concerne les DOCUMENTS D'ACCOMPAGNEMENT du TOMODENSITOMETRE. Le présent document ne s'applique pas aux: • aspects concernant la sécurité mécanique et électrique; et • aspects concernant les performances mécaniques, électriques et logicielles, à moins qu'ils ne soient essentiels à l'exécution des ESSAIS D'ACCEPTATION et des ESSAIS DE CONSTANCE, et qu'ils affectent directement la qualité d'image, la PUISSANCE DE RAYONNEMENT et le positionnement du PATIENT. L'IEC 61223-3-5:2019 annule et remplace la première édition parue en 2004 et la deuxième édition de l'IEC 61223-2-6 parue en 2006. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente et à l'IEC 61223-2-6: a) modification de la protection contre les RAYONNEMENTS et des contrôles; b) modification des essais d'acceptation; c) introduction des essais de constance.

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)

Ta dokument se uporablja za NAPRAVE CT, ki ustrezajo standardom IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 in IEC 60601-2-44:2009/AMD2:2016. Standard IEC 60601-2-44 in ta dokument: – določa osnovne parametre, ki opisujejo delovanje NAPRAV CT, kar zadeva kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA; seznam parametrov, ki jih je treba preskusiti, je na voljo v točki 4.3, – določa postopke za preskušanje osnovnih parametrov; in – vrednoti skladnost s tolerancami parametrov, ki jih DOLOČAJO SPREMLJEVALNI DOKUMENTI. Postopki, določeni v standardu IEC 60601-2-44 in v tem dokumentu, se opirajo na neinvazivne meritve z uporabo ustrezne preskuševalne opreme, ki se opravijo med namestitvijo ali po njej. Podpisane izjave, ki zajemajo korake postopka namestitve, je mogoče uporabiti kot del poročila o PRESKUSU SPREJEMLJIVOSTI. Ta dokument se uporablja za PRESKUSE SPREJEMLJIVOSTI in PRESKUSE NESPREMENLJIVOSTI na NAPRAVAH CT. Namen PRESKUSOV SPREJEMLJIVOSTI je potrditi skladnost namestitve ali VEČJEGA SERVISNEGA DELA s specifikacijami, ki vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA. PRESKUSI NESPREMENLJIVOSTI se izvajajo, da se zagotovi, da zmogljivost delovanja OPREME ustreza UVELJAVLJENIM MERILOM, ter da se omogoči zgodnje prepoznavanje sprememb v lastnostih komponent OPREME in preveri skladnost s specifikacijami, ki vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA. Ta dokument vsebuje tudi zahteve, povezane s PRESKUSOM SPREJEMLJIVOSTI in PRESKUSOM NESPREMENLJIVOSTI, za SPREMLJEVALNE DOKUMENTE NAPRAVE CT. Ta dokument se ne uporablja za: – vidike mehanske in električne varnosti; ter – vidike mehanskega in električnega delovanja ter delovanja programske opreme, razen če so ti bistveni za izvajanje PRESKUSOV SPREJEMLJIVOSTI in PRESKUSOV NESPREMENLJIVOSTI ter neposredno vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA.

General Information

• Status: Published
• Publication Date: 07-Nov-2019
• Withdrawal Date: 20-Oct-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 08-Nov-2019
• Completion Date: 08-Nov-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN IEC 61223-3-5:2020 - 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)

Relations

• Replaces: EN 61223-2-6:2007 - Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
• Effective Date: 25-Jan-2023
• Replaces: EN 61223-3-5:2004 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
• Effective Date: 24-Jan-2017
• Corrected By: EN IEC 61223-3-5:2019/AC:2022-07 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
• Effective Date: 28-Jun-2022

Overview

EN IEC 61223-3-5:2019 (IEC 61223-3-5:2019) is a European/CENELEC adoption of the IEC standard for acceptance and constancy tests of computed tomography (CT) X‑ray equipment. It applies to CT scanners that conform to IEC 60601-2-44 (2009) including its amendments. The standard defines the essential imaging performance parameters (image quality, radiation output and patient positioning), prescribes non‑invasive test methods, and describes how to evaluate compliance with tolerances specified in the equipment’s accompanying documents.

Key Topics and Requirements

• Scope: Acceptance tests after installation or major service and routine constancy (quality control) tests during operation.
• Essential parameters: Image quality metrics, radiation output (dose), and patient positioning accuracy.
• Test methods: Non‑invasive measurements using appropriate test equipment; procedures for establishing baseline values and documenting test conditions.
• Specific tests covered (detailed in the standard): reconstructed section thickness, dose measurements, mean CT number, noise and uniformity, high‑contrast spatial resolution, low‑contrast resolution/detectability, automated exposure control (AEC), gantry tilt accuracy and z‑axis resolution, dose profiling.
• Constancy testing: Frequency guidance, criteria for alerts and corrective actions, and procedures after major service actions.
• Exclusions: Routine mechanical/electrical safety and general software performance are out of scope unless they directly affect image quality, radiation output or patient positioning.
• Documentation: Requirements for baseline records, test devices, and acceptance test reports (signed statements from installation steps are acceptable parts of reports).

Applications and Practical Value

• Ensures that newly installed or serviced CT scanners meet manufacturer and regulatory imaging and dose specifications before clinical use.
• Provides a structured QA/QC program for radiology departments to detect drift in image quality or dose - enabling early corrective action and consistent patient safety.
• Supports compliance with hospital accreditation, regulatory requirements and best practices in medical imaging quality assurance.
• Enables standardized reporting and traceable baseline comparisons for imaging performance across equipment and sites.

Who Uses This Standard

• Medical physicists and clinical engineers responsible for CT acceptance and routine QC
• Radiology department managers and quality managers
• Biomedical service engineers and equipment installers
• Regulatory authorities, accreditation auditors and health‑care safety officers

Related Standards

• IEC 60601-2-44 (X‑ray equipment for CT) - primary product safety and essential performance standard
• IEC 60601-1 (general medical electrical equipment safety)
• IEC/TR 60788 (glossary of defined terms)
• IEC 61674 (related harmonized standards referenced in the normative bibliography)

This standard is essential for consistent, documented CT acceptance testing and ongoing constancy checks to maintain image quality, control radiation output and ensure accurate patient positioning.

Standards Content (Sample)

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

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

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)

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
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

– 2 – IEC 61223-3-5:2019 © IEC 2019
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

IEC 61223-3-5:2019 © IEC 2019 – 3 –
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

– 4 – IEC 61223-3-5:2019 © IEC 2019
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

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
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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.

– 6 – IEC 61223-3-5:2019 © IEC 2019
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.

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 60601-2-44:2009/AMD1:2012 and IEC 60601-
2-44:2009/AMD2:2016.
Some provisions or statements in this document require additional information, which is
presented in the annexes.
IEC 61223-3-5 is referenced by IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012
using an undated reference. This can suggest the reference to change from
IEC 61223-3-5:2004 to IEC 61223-3-5:2019 with the date of its publication. However, the IEC
technical subcommittee 62B who prepared both standards does not intend this immediate
change of reference. The IEC technical subcommittee 62B clearly recommends in the
foreword of both standards the necessity for MANUFACTURERS and testing organizations for a
transitional period to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. Therefore, the reference in IEC 60601-2-44
has to be seen as a dated reference towards IEC 61223-3-5:2004, for a transitional period of
not less than 3 years from the date of publication of this document. The IEC technical
subcommittee 62B intends to clarify this undated reference with the preparation of a new
version 4 of IEC 60601-2-44.
– 8 – IEC 61223-3-5:2019 © IEC 2019
EVALUATION AND ROUTINE TESTING IN
MEDICAL IMAGING DEPARTMENTS –
Part 3-5: Acceptance and Constancy tests – Imaging
performance of computed tomography X-ray equipment

1 Scope and object
This part of IEC 61223 applies to CT SCANNERS that conform to IEC 60601-2-44:2009,
IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016.
IEC 60601-2-44 and this document
• defines the essential parameters which describe the performance of CT SCANNERS with
regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters
to be tested can be found in 4.3,
• defines the methods of testing the essential parameters, and
• evaluates compliance with the tolerances of the parameters SPECIFIED by the
ACCOMPANYING DOCUMENTS.
The methods defined in IEC 60601-2-44 and this document rely on non-invasive
measurements, using appropriate test equipment, performed during or after installation.
Signed statements covering steps in the installation procedure can be used as part of the
ACCEPTANCE TEST report.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim
of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION
with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The
CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT
meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties
of components of the EQUIPMENT, and to verify compliance with specifications affecting the
image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements associated with ACCEPTANCE TEST and CONSTANCY
TEST for the ACCOMPANYING DOCUMENTS of the CT SCANNER.
This document does not apply to
• aspects of mechanical and electrical safety, and
• aspects of mechanical, electrical and software performance, unless they are essential for
performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image
quality, RADIATION OUTPUT and PATIENT positioning.
NOTE 1 If a user of this document wishes to apply this document to CT SCANNERS that were designed to comply
with editions of IEC 60601-2-44:2009 and earlier, understanding and adjustment for the different definitions that
have been used for CTDI is critical. Additionally, the ACCOMPANYING DOCUMENTS for CT scanners that were
vol
designed and manufactured to these older editions can be referenced to obtain applicable specifications.
NOTE 2 It is possible the accompanying documents that were compiled in accordance with IEC 60601-2-44:2009
and IEC 60601-2-44:2009/AMD1:2012 or IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-
2-44:2009/AMD2:2016 do not include all the needed content and specifications identified in this document prior to
the completion of the transition period to this document.

IEC 61223-3-5:2019 © IEC 2019 – 9 –
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/AMD1:2012
IEC 60601-2-44:2009, Medical electrical equipment – Part 2-44: Particular requirements for
the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44:2009/AMD1:2012
IEC 60601-2-44:2009/AMD2:2016
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC TR 60788,
IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/
AMD2:2016 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 Terms printed in SMALL CAPITALS are used in accordance with their definitions in the documents referred
to in the Index of defined terms at the end of this document.
NOTE 2 Attention is drawn to the fact that in cases where the concept addressed is not strongly confined to the
definition given in one of the publications listed above, a corresponding term is printed in lower case letters.
NOTE 3 Associated conditions qualifying the usage of certain terms are given below.
3.1
ACCEPTANCE TEST
test performed after new equipment has been installed, or MAJOR SERVICE ACTIONS have been
made to existing equipment, in order to verify that the functional performance of equipment
meets ESTABLISHED CRITERIA from the MANUFACTURER, contractual specifications, and/or
requirements of this document
Note 1 to entry: The ESTABLISHED CRITERIA verified are specifications affecting the image quality, RADIATION
OUTPUT and PATIENT positioning. Additionally, during or immediately after the ACCEPTANCE TEST, the BASELINE
VALUES for CONSTANCY TEST are established.
3.2
CONSTANCY TEST
test performed to verify that the functional performance of EQUIPMENT meets ESTABLISHED
CRITERIA and to enable the early recognition of changes in the properties of components of the
EQUIPMENT
Note 1 to entry: The test verifies conformance with specifications affecting the image quality, radiation output and
PATIENT positioning.
3.3
CT CONDITIONS OF OPERATION
selectable parameters governing the operation of a CT SCANNER

– 10 – IEC 61223-3-5:2019 © IEC 2019
Note 1 to entry: Examples of such conditions include NOMINAL TOMOGRAPHIC SECTION THICKNESS, CT PITCH
FACTOR, FILTRATION, peak X-RAY TUBE VOLTAGE and either X-RAY TUBE CURRENT and LOADING TIME or CURRENT TIME
PRODUCT.
Note 2 to entry: Some CT CONDITIONS OF OPERATION may vary during the exposure.
Note 3 to entry: CT CONDITIONS OF OPERATION include parameters that are derived by the system from the user-
selectable parameters.
[SOURCE: IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012, 201.3.202]
3.4
CT DOSE INDEX 100
CTDI
integral of the DOSE PROFILE representative of a single axial scan along a line perpendicular to
the TOMOGRAPHIC PLANE divided by N x T according to the following:
for N × T less than or equal to 40 mm
+50 mm
D (z)
=  dz
CTDI100
∫
N × T
−50 mm
for N × T greater than 40 mm (all CT CONDITIONS OF OPERATION except collimation are kept the
same for these measurements)
+50 mm
D (z) CTDI
Ref free air, N×T
=  dz×
CTDI
∫
(N×T) CTDI
Ref free air, Ref
−50 mm
where
D(z) is the DOSE PROFILE representative of a single axial scan along a line z
perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as
ABSORBED DOSE in air and is evaluated within a polymethylmethacrylate
(PMMA) dosimetry PHANTOM (see IEC 60601-2-44:2009 and IEC 60601-2-
44:2009/AMD1:2012, 203.108);
(N × T) is a SPECIFIC N × T of 20 mm or the largest N × T available not greater
Ref
than 20 mm;
D (z) is the DOSE PROFILE representative of a single axial scan along a line z
Ref
perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as
ABSORBED DOSE in air and is evaluated within a polymethylmethacrylate
(PMMA) dosimetry PHANTOM (see IEC 60601-2-44:2009 and
IEC 60601-2-44:2009/AMD1:2012, 203.108) for (N × T) ;
Ref
CTDI is the CTDI (IEC 60601-2-44:2009 and
free air, N × T free air
IEC 60601-2-44:2009/AMD1:2012, 201.3.215) for a SPECIFIC value of
N × T;
CTDI is the CTDI (IEC 60601-2-44:2009 and
free air, Ref free air
IEC 60601-2-44:2009/AMD1:2012, 201.3.215) for (N × T) ;
Ref
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan
of the X-ray source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS
Note 1 to entry: The dose is reported as ABSORBED DOSE to air, but for practical purposes the evaluation of
ABSORBED DOSE to air within a PMMA dosimetry PHANTOM is well approximated by measurement of the AIR KERMA.
Note 2 to entry: This definition assumes that the DOSE PROFILE is centred on z = 0.
Note 3 to entry: A single axial scan is typically a 360° rotation of the X-ray source.
Note 4 to entry: When the TOMOGRAPHIC SECTIONS overlap, for example in CT SCANNERS with a "z-flying FOCAL
SPOT", the denominator of the integral needs to be replaced by the total nominal width along z of overlapping

IEC 61223-3-5:2019 © IEC 2019 – 11 –
TOMOGRAPHIC SECTIONS. For example, if the percentage of overlap is 50 %, then the denominator would be
replaced by 0,5 × N × T.
Note 5 to entry: Typically the z-axis is the axis of rotation.
Note 6 to entry: See Annex CC of IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012 for explanation.
[SOURCE: IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012, 201.3.203, modified
– In the term, "computed tomography" has been replaced by "CT". Note 6 has been deleted,
and Note 7 renumbered Note 6.]
3.5
CT DOSE INDEX MEASURED FREE-IN-AIR
CTDI
free air
integral of the DOSE PROFILE representative of a single axial scan along a line through the
ISOCENTRE and perpendicular to the TOMOGRAPHIC PLANE divided by N × T according to the
following
+L/2
D (z)
=  dz
CTDIfree air
∫
N × T
−L/2
where
D(z) is the DOSE PROFILE representative of a single axial scan along a line z through
ISOCENTRE and perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as
ABSORBED DOSE in air and is evaluated free-in-air in the absence of a PHANTOM and
the PATIENT SUPPORT;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray
source;
NOMINAL TOMOGRAPHIC SECTION THICKNESS;
T is the
L is at least (N × T) +40 mm, but not less than 100 mm
Note 1 to entry: This definition assumes that the DOSE PROFILE is centred on z = 0.
Note 2 to entry: When the TOMOGRAPHIC SECTIONS overlap, for example in CT SCANNERS with a "z-flying FOCAL
SPOT", the denominator of the integral needs to be replaced by the total nominal width along z of overlapping
TOMOGRAPHIC SECTIONS. For example, if the percentage of overlap is 50 %, then the denominator would be
replaced by 0,5 × N × T.
Note 3 to entry: Typically, a RADIATION DETECTOR of length L or longer is used. Annex DD of
IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2016 and IEC 60601-2-44:2009/AMD2:2016 provides an
example for alternate measurements.
[SOURCE: IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012, 201.3.215, modified
– In the term, "computed tomography" has been replaced by "CT".]
3.6
CT NUMBER
ATTENUATION associated with each elemental area
number used to represent the mean X-ray
of the COMPUTED TOMOGRAPHY image
Note 1 to entry: The CT NUMBER is normally expressed in Hounsfield units. MEASURED VALUES of the linear
ATTENUATION coefficients are transformed into CT NUMBERS using the international Hounsfield scale, using the
expression:
µ −µ
material water
CT NUMBER= × 1 000
µ
water
where
μ is the linear ATTENUATION coefficient.
Note 2 to entry: The CT NUMBER scale is defined so that water has a value of 0 and air a value of –1 000 (μ is
air
assumed to be 0).
– 12 – IEC 61223-3-5:2019 © IEC 2019
3.7
CT PITCH FACTOR
in helical scanning the ratio of the PATIENT SUPPORT travel Δd along the z direction per rotation
of the X-ray source divided by the product of the NOMINAL TOMOGRAPHIC SECTION THICKNESS T
and the number of TOMOGRAPHIC SECTIONS N:
∆d
CT pitch factor=
N×T
where
∆d is the PATIENT SUPPORT travel along the z-direction per rotation of the X-RAY SOURCE;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-RAY
SOURCE.
Note 1 to entry: Although the CT PITCH FACTOR is associated with helical scanning, its definition refers to
parameters T and N that are defined only for axial scanning. This definition of CT PITCH FACTOR presumes that
these axial-scanning parameters T and N correspond to the same collimation and active-detector configuration as
that of the helical scanning for which the CT PITCH FACTOR is being evaluated.
Note 2 to entry: When the TOMOGRAPHIC SECTIONS overlap, for example in CT SCANNERS with a "z-flying FOCAL
SPOT", the denominator of the integral needs to be replaced by the total nominal width along z of overlapping
TOMOGRAPHIC SECTIONS. For example, if the percentage of overlap is 50 %, then the denominator would be
replaced by 0,5 × N × T.
Note 3 to entry: CT PITCH FACTOR will be a function of time when Δd is variable during the exposure.
Note 4 to entry: The terms "helical" is used in this document as a synonym for the term "spiral".
[SOURCE: IEC 60601-2-44:2009 and IEC 60601-2-44:2009/AMD1:2012, 201.3.204, modified
– Note 2 has been replaced by a new note.]
3.8
CT SCANNER
X-RAY EQUIPMENT intended to generate cross-sectional images of the body by computer
reconstruction of X-ray transmission data obtained at different angles, which may include
signal analysis and display equipment, PATIENT SUPPORT, support parts and ACCESSORIES
Note 1 to entry: The scope of IEC 60601-2-44:2009 is limited to CT SCANNERS intended to
...