EN 61223-3-5:2004

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
” IEC 2004 Droits de reproduction réservés  Copyright - all rights reserved
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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
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,
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in the subject dealt with may participate in this preparatory work. International, governmental and non-
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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.
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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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.
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
...