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

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
...