EN 61223-3-5:2004
(Main)Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
This standard - defines the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning; - defines the methods of testing the essential parameters; - evaluates compliance with the tolerances of the parameters specified by the accompanying documents. These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during the installation or after it has been completed. Signed statements covering steps in the installation procedure may be used as part of the acceptance test report. This part of EN 61223 is intended to assist in performing the acceptance tests on a CT scanner. The aim is to verify compliance of the installation with specifications affecting the image quality, patient dose and positioning.
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 - Performance d'imagerie des équipements de tomodensitométrie à rayonnement X
Cette norme - définit les paramètres importants qui décrivent les performances des tomodensitomètres en ce qui concerne la qualité d'image, la dose délivrée au patient et le positionnement; - définit les méthodes d'essais des paramètres importants; - évalue la conformité des paramètres par rapport aux tolérances spécifiées dans les documents d'accompagnement. Ces méthodes s'appuient principalement sur des mesures non invasives, exécutées pendant l'installation ou à l'issue de celle-ci, en utilisant les équipements d'essai appropriés. Des déclarations signées couvrant des étapes de la procédure d'installation peuvent être utilisées dans le cadre du rapport d'essai d'acceptation. La présente partie de la EN 61223 est destinée à aider à la réalisation des essais d'acceptation d'un tomodensitomètre. Le but est de vérifier la conformité de l'installation aux spécifications concernant la qualité de l'image, la dose délivrée au patient et lepositionnement.
Ovrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje – 3-5. del: Preskusi sprejemljivosti – Slikovni učinek rentgenske opreme za računalniško podprto tomografijo
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Standards Content (Sample)
SLOVENSKI SIST EN 61223-3-5:2005
STANDARD
januar 2005
Ovrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje – 3-
5. del: Preskusi sprejemljivosti – Slikovni učinek rentgenske opreme za
računalniško podprto tomografijo
(istoveten 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
ICS 11.040.50 Referenčna številka
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
EUROPEAN STANDARD EN 61223-3-5
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2004
ICS 11.040.50
English version
Evaluation and routine testing in medical imaging departments
Part 3-5: Acceptance tests –
Imaging performance of computed tomography X-ray equipment
(IEC 61223-3-5:2004)
Essais d'évaluation et de routine Bewertung und routinemäßige Prüfung in
dans les services d'imagerie médicale Abteilungen für medizinische Bildgebung
Partie 3-5: Essais d'acceptation – Teil 3-5: Abnahmeprüfungen –
Performance d'imagerie des équipements Leistungsmerkmale zur Bildgebung
de tomodensitométrie à rayonnement X von Röntgeneinrichtungen für
(CEI 61223-3-5:2004) Computertomographie
(IEC 61223-3-5:2004)
This European Standard was approved by CENELEC on 2004-09-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and 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
© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61223-3-5:2004 E
Foreword
The text of document 62B/525/FDIS, future edition 1 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 was approved by CENELEC as EN 61223-3-5 on 2004-09-01.
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) 2005-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-09-01
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, EN 60788, EN 61223-1 OR IN OTHER STANDARDS REFERENCED IN
ANNEX A: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61223-3-5:2004 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 61223-2-4 NOTE Harmonized as EN 61223-2-4:1994 (not modified).
IEC 61223-2-6 NOTE Harmonized as EN 61223-2-6:1994 (not modified).
IEC 60336 NOTE Harmonized as EN 60336:1995 (not modified).
IEC 60522 NOTE Harmonized as EN 60522:1999 (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 61267:1994 (not modified).
__________
- 3 - EN 61223-3-5:2004
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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60601-1 - Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety
IEC 60601-2-44 2001 Part 2-44: Particular requirements for the EN 60601-2-44 2001
safety of X-ray equipment for computed
tomography
A1 2002 A1 2003
1)
IEC/TR 60788 - Medical electrical equipment - Glossary of - -
defined terms
1)
Undated reference.
2)
Valid edition at date of issue.
NORME CEI
INTERNATIONALE IEC
61223-3-5
INTERNATIONAL
Première édition
STANDARD
First edition
2004-08
Essais d'évaluation et de routine
dans les services d'imagerie médicale –
Partie 3-5:
Essais d'acceptation –
Performance d'imagerie des équipements
de tomodensitométrie à rayonnement X
Evaluation and routine testing
in medical imaging departments –
Part 3-5:
Acceptance tests –
Imaging performance of computed
tomography X-ray equipment
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microfilms, sans l'accord écrit de l'éditeur. the publisher.
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Pour prix, voir catalogue en vigueur
For price, see current catalogue
61223-3-5 ” IEC:2004 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope and object.11
2 Normative references.11
3 Terms and definitions .13
4 General aspects of ACCEPTANCE TESTS .23
4.1 General conditions to be considered in test procedures .23
4.2 Documents and data for the tests.23
4.3 Identification of EQUIPMENT, instrumentation and test conditions.23
4.4 Scope of tests.25
4.5 Test EQUIPMENT, including PHANTOMS and TEST DEVICES .25
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.35
5.5 NOISE, MEAN CT NUMBER and UNIFORMITY .37
5.6 SPATIAL RESOLUTION .41
Annex A (normative) Terminology – Index of defined terms.43
Annex B (informative) Recommended criteria for test results .47
Annex C (informative) Visual Method for LOW CONTRAST RESOLUTION .49
Annex D (informative) Accuracy of the gantry tilt .51
Annex E (informative) DOSE PROFILE.53
Annex F (informative) Alternate test methods for SPATIAL RESOLUTION.55
Annex G (informative) TOMOGRAPHIC SECTION THICKNESS for helical scanning.61
Bibliography .63
Figure 1 – Coordinate system .19
Table 1 Test pattern for dose .37
Table F.1 Comparison of SPATIAL RESOLUTION test procedures.55
61223-3-5 ” IEC:2004 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –
Part 3-5: Acceptance tests –
Imaging performance of computed tomography
X-ray equipment
FOREWORD
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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.
The text of this standard is based on the following documents:
FDIS Report of voting
62B/525/FDIS 62B/544/RVD
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
61223-3-5 ” IEC:2004 – 7 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
IEC 61223-3 includes the following parts, under the general title Evaluation and routine
testing in medical imaging departments – Part 3: Acceptance tests:
Part 3-1: Imaging performance of X-ray equipment for radiogra
...
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