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

This part of IEC 61223 provides assistance in performing constancy tests on a CT scanner. It applies to those components of CT scanners which influence the image quality, patient dose and positioning. This standard - defines the essential parameters which describe the performance of CT scanners with regard to image quality, patient dose and positioning; the list of parameters to be tested can be found in section 4.5; - defines the methods of testing the essential parameters; - provides criteria to be applied in the evaluation of data for compliance with the tolerances of the parameters specified by the accompanying documents and with respect to baseline values. These methods rely on non-invasive measurements, using appropriate test equipment, performed 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. The aim is to verify compliance with specifications affecting the image quality, patient dose and patient positioning.

Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 2-6: Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen für die Computertomographie

Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 2-6: Essais de constance - Performance d'imagerie des équipements de tomodensitométrie à rayonnement X

La présente partie de la CEI 61223 fournit une aide à la réalisation des essais de constance des tomodensitomètres. Elle s'applique aux composants des tomodensitomètres qui influencent la qualité de l'image, la dose patient et le positionnement. La présente norme - définit les paramètres essentiels qui décrivent les performances des tomodensitomètres concernant la qualité de l'image, la dose patient et le positionnement; la liste des paramètres à soumettre aux essais peut être trouvée au paragraphe 4.5; - définit les méthodes d'essai des paramètres essentiels; - fournit les critères à appliquer lors de l'évaluation des données pour établir la conformité aux tolérances des paramètres spécifiés par les documents d'accompagnement et concernant les valeurs de base. Ces méthodes reposent sur des mesurages non invasifs, utilisant des équipements d'essai appropriés, réalisés pour s'assurer que la performance fonctionnelle de l'équipement satisfait aux critères établis ou pour permettre une reconnaissance précoce des variations des propriétés des composants de l'équipements. Le but recherché est la vérification de la conformité aux spécifications concernant la qualité de l'image, la dose patient et le positionnement du patient.

Vrednotenje in rutinsko preskušanje v oddelkih za medicinsko slikanje - 2-6. del: Preskus konstantnosti - Rentgenska oprema za računalniško tomografijo (IEC 61223-2-6:2006)

Ta del IEC 61223 predpisuje pomoč pri izvajanju PRESKUSOV KONSTANTNOSTI pri RENTGENU ZA RAČUNALNIŠKO TOMOGRAFIJO. Velja za tiste komponente RENTGENOV ZA RAČUNALNIŠKE TOMOGRAFIJE, ki vplivajo na kvaliteto slike, odmerek na PACIENTA in pozicioniranje. Ta standard opredeljuje bistvene parametre, ki opisujejo zmogljivost RENTGENOV ZA RAČUNALNIŠKO TOMOGRAFIJO glede  kvalitete slike, odmerka za PACIENTA in pozicioniranja; seznam parametrov, ki se jih preskuša, se nahaja v Razdelku 4.5.; - opredeljuje metode preskušanja bistvenih parametrov; zagotavlja merila za uporabo pri vrednotenju podatkov za skladnost z odstopanji parametrov, ki jih določajo SPREMNI DOKUMENTI in ob upoštevanju SREDNJIH VREDNOSTI. Te metode se opirajo na neinvazivna merjenja z uporabo primerne preskusne opreme in delujejo tako, da se za funkcionalno zmogljivost OPREME zagotovi, da izpolnjuje VZPOSTAVLJENA MERILA ali da omogoča zgodnje prepoznavanje sprememb lastnosti komponent OPREME. Cilj je potrditi skladnost s specifikacijami, ki vplivajo na kakovost slike, odmerka za PACIENTA in pozicioniranje PACIENTA. Njegov namen ni, da upošteva: - vidike mehanske in električne varnosti, niti - vidike mehanske in električne zmogljivosti ter zmogljivosti programske opreme, razen če so le-ti bistveni za izvajanje PRESKUSOV KONSTANTNOSTI in neposredno vplivajo na kakovost slike, odmerka za PACIENTA in njegovo pozicioniranje.

General Information

• Status: Withdrawn
• Publication Date: 08-May-2007
• Withdrawal Date: 28-Feb-2010
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 08-Nov-2019
• Ref Project: SIST EN 61223-2-6:2010 - Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment (IEC 61223-2-6:2006)

Relations

• Replaces: EN 61223-2-6:1994 - Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - X-ray equipment for computed tomography
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 25-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2010
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SIST EN 61223-2-6:1998
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3UHVNXVNRQVWDQWQRVWL5HQWJHQVNDRSUHPD]DUDþXQDOQLãNRWRPRJUDILMR,(&

Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy
tests - Imaging performance of computed tomography X-ray equipment (IEC 61223-2-
6:2006)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
2-6: Konstanzprüfungen - Röntgeneinrichtungen für die Computertomographie (IEC
61223-2-6:2006)
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 2-6:
Essais de constance - Performance d'imagerie des équipements de tomodensitométrie à
rayonnement X (CEI 61223-2-6:2006)
Ta slovenski standard je istoveten z: EN 61223-2-6:2007
ICS:
11.040.50 Radiografska oprema Radiographic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61223-2-6
NORME EUROPÉENNE
May 2007
EUROPÄISCHE NORM
ICS 11.040.50 Supersedes EN 61223-2-6:1994

English version
Evaluation and routine testing in medical imaging departments -
Part 2-6: Constancy tests -
Imaging performance of computed tomography X-ray equipment
(IEC 61223-2-6:2006)
Essais d'évaluation et de routine  Bewertung und routinemäßige Prüfung
dans les services d'imagerie médicale - in Abteilungen
Partie 2-6: Essais de constance - für medizinische Bildgebung -
Performance d'imagerie des équipements Teil 2-6: Konstanzprüfungen -
de tomodensitométrie à rayonnement X Röntgeneinrichtungen
(CEI 61223-2-6:2006) für die Computertomographie
(IEC 61223-2-6:2006)
This European Standard was approved by CENELEC on 2007-03-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61223-2-6:2007 E
Foreword
The text of document 62B/629/FDIS, future edition 2 of IEC 61223-2-6, prepared by SC 62B, Diagnostic
imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 61223-2-6 on 2007-03-01.
This European Standard supersedes EN 61223-2-6:1994.
EN 61223-3-5:2004. Instead of harmonizing test procedures for all modalities of X-ray equipment, as
intended in EN 61223-2-6:1994, this EN 61223-2-6:2007 comprises part of a set of standards covering all
of the particular requirements for CT scanners.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-12-01
– latest date by which the national standards conflicting
(dow) 2010-03-01
with the EN have to be withdrawn
In this standard, 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 DEFINED IN EN 60601-1, IN EN 60788, IN EN 61223-1 OR IN OTHER PUBLICATIONS REFERENCED IN
THE INDEX OF DEFINED TERMS: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61223-2-6:2006 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 61223-2-5 NOTE  Harmonized as EN 61223-2-5:1994 (not modified).
IEC 61223-2-4 NOTE  Harmonized as EN 61223-2-4:1994 (not modified).
IEC 60336 NOTE  Harmonized as EN 60336:2005 (not modified).
IEC 60522 NOTE  Harmonized as EN 60522:1999 (not modified).
IEC 60601-1 NOTE  Harmonized as EN 60601-1:2006 (not modified).
IEC 60601-2-28 NOTE  Harmonized as EN 60601-2-28:1993 (not modified).
IEC 60601-2-32 NOTE  Harmonized as EN 60601-2-32:1994 (not modified).
IEC 61267 NOTE  Harmonized as EN 61267:2006 (not modified).
__________
- 3 - EN 61223-2-6:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60601-2-44 2001 Medical electrical equipment - EN 60601-2-44 2001
A1 2002 Part 2-44: Particular requirements for the A1 2003
safety of X-ray equipment for computed
tomography
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61223-3-5 2004 Evaluation and routine testing in medical EN 61223-3-5 2004
imaging departments -
Part 3-5: Acceptance tests - Imaging
performance of computed tomography X-ray
equipment
NORME CEI
INTERNATIONALE
IEC
61223-2-6
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2006-11
Essais d’évaluation et de routine dans
les services d’imagerie médicale –
Partie 2-6:
Essais de constance –
Performance d’imagerie des équipements
de tomodensitométrie à rayonnement X

Evaluation and routine testing in
medical imaging departments –
Part 2-6:
Constancy tests –
Imaging performance of computed
tomography X-ray equipment
© IEC 2006 Droits de reproduction réservés ⎯ Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
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Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

61223-2-6 © IEC:2006 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9

1 Scope and object.11
2 Normative references .11
3 Terms and definitions .13
4 General aspects of CONSTANCY TESTS .21
4.1 Preconditions .21
4.2 General conditions affecting test procedures .21
4.3 Establishment of BASELINE VALUES .23
4.4 Identification of equipment, instrumentation and test conditions .23
4.5 Scope of the CONSTANCY TESTS.25
4.6 Test equipment, including PHANTOMS and TEST DEVICES .25
4.7 Frequency of CONSTANCY TESTS .27
5 Test methods for CT SCANNERS.27
5.1 Positioning of the PATIENT SUPPORT.27
5.2 PATIENT positioning accuracy .29
5.3 TOMOGRAPHIC SECTION THICKNESS .33
5.4 Dose .37
5.5 NOISE, UNIFORMITY AND MEAN CT NUMBERS .39
5.6 SPATIAL RESOLUTION.43

Annex A (informative) Guidance on action to be taken .47
Annex B (informative) Alternate test methods for SPATIAL RESOLUTION .51
Annex C (informative) TOMOGRAPHIC SECTION THICKNESS for helical scanning .57
Annex D (informative) Visual method for LOW CONTRAST RESOLUTION .59

Bibliography.61

Index of terms.65

Figure 1 – Coordinate system used for CT SCANNERS.21

Table B.1 − Comparison of SPATIAL RESOLUTION test procedures .51

61223-2-6 © IEC:2006 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 2-6: Constancy tests – Imaging performance
of computed tomography X-ray equipment

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