EN 61223-3-3:1996
(Main)Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)
Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)
Applies to those components of X-ray equipment which influence the image quality of equipment for digital subtraction angiography (DSA) with an imaging system consisting of an X-ray generation subsystem, a detection device comprising an X-ray image intensifier television chain, means of digitization and digital image processing, image storage and image manipulation including subtraction, and facilities for image display. Defines the essential parameters which describe the performance of the above-mentioned components of X-ray equipment with regard to imaging properties, and defines methods of testing whether measured quantities related to those parameters comply with specified tolerances.
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-3: Abnahmeprüfungen - Abbildungsleistung von Röntgen-Einrichtungen für Digitale Subtraktionsangiographie
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-3: Essais d'acceptation - Performance d'imagerie des équipements à rayonnement X d'angiographie numérique soustractive (ANS)
S'applique aux composants d'équipement à rayonnement X qui influent sur la qualité d'image des appareils d'angiographie numérique soustractive (ANS) comportant un dispositif d'imagerie formant un sous-ensemble de la production de rayonnement X, un dispositif de détection comprenant une chaine de télévision à intensificateur d'imagerie radiologique, des moyens de numérisation, de traitement de l'image numérisée, de stockage de l'image et de transformation de l'image, soustraction comprise, et les installations d'affichage d'image. Définit les paramètres essentiels décrivant les performances des parties composant un équipement à rayonnement X mentionnées ci-dessus en ce qui concerne les propriétés d'imagerie, et définit les méthodes d'essai pour déterminer si les quantités mesurées liées à ces paramètres sont en accord avec les tolérances spécifiées.
Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) (IEC 61223-3-3:1996)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-1998
Evaluation and routine testing in medical imaging departments - Part 3-3:
Acceptance tests - Imaging performance of X-ray equipment for digital subtraction
angiography (DSA) (IEC 61223-3-3:1996)
Evaluation and routine testing in medical imaging departments -- Part 3-3: Acceptance
tests - Imaging performance of X-ray equipment for digital subtraction angiography
(DSA)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung -- Teil
3-3: Abnahmeprüfungen - Abbildungsleistung von Röntgen-Einrichtungen für Digitale
Subtraktionsangiographie
Essais d'évaluation et de routine dans les services d'imagerie médicale -- Partie 3-3:
Essais d'acceptation - Performance d'imagerie des équipements à rayonnement X
d'angiographie numérique soustractive (ANS)
Ta slovenski standard je istoveten z: EN 61223-3-3:1996
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
NORME
CEI
INTERNATIONALE
IEC
1223-3-3
INTERNATIONAL
Première édition
STANDARD
First edition
1996-11
Essais d’évaluation et de routine
dans les services d’imagerie médicale –
Partie 3-3:
Essais d’acceptation – Performances d’imagerie
des équipements à rayonnement X
d’angiographie numérique soustractive (ANS)
Evaluation and routine testing
in medical imaging departments –
Part 3-3:
Acceptance tests – Imaging performance
of X-ray equipment for digital subtraction
angiography (DSA)
CEI 1996 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
utilisée sous quelque forme que ce soit et par aucun procédé, in any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la photocopie et les including photocopying and microfilm, without permission
microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher
Bureau central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, Suisse
CODE PRIX
Commission Electrotechnique Internationale
R
International Electrotechnical Commission PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue
1223-3-3 © IEC:1996 − 3 −
CONTENTS
Page
FOREWORD . 5
INTRODUCTION . 9
Clause
1 Scope and object. 11
1.1 Scope . 11
1.2 Object . 11
2 Normative references . 11
3 Terminology . 13
3.1 Degree of requirements . 13
3.2 Use of terms. 15
3.3 Defined terms. 15
4 General aspects of ACCEPTANCE TESTS. 15
4.1 General conditions to be considered in test procedures. 15
4.2 Documents and data for the tests . 17
4.3 Test conditions . 17
4.4 Test parameters . 17
4.5 Test equipment including PHANTOMS and TEST DEVICES. 19
4.6 Evaluating the test results. 21
5 Test methods for X-RAY EQUIPMENT for DSA . 21
5.1 Identification. 21
5.2 Check of documents . 21
5.3 Decision on representative DSA operation modes . 21
5.4 Visual and functional tests . 23
5.5 AIR KERMA measurements . 23
5.6 DYNAMIC RANGE . 23
5.7 DSA CONTRAST SENSITIVITY . 23
5.8 DSA VISUAL SPATIAL RESOLUTION . 25
5.9 ARTIFACTS . 25
5.10 Compensation for ATTENUATION non-linearity (optional) . 25
6 Test report and statement of compliance. 27
Annexes
A Terminology – Index of defined terms . 29
B Example of a DSA PHANTOM without test step for compensation . 33
C Example of a DSA PHANTOM with test step for compensation . 37
1223-3-3 © IEC:1996 − 5 −
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –
Part 3-3: Acceptance tests –
Imaging performance of X-ray equipment
for digital subtraction angiography (DSA)
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt
with may participate in this preparatory work. International, governmental and non-governmental organizations
liaising with the IEC also participate in this preparation. The IEC collaborates closely 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the
form of standards, technical reports or guides and they are accepted by the National Committees in that
sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 1223-3-3 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 on voting
62B/288/FDIS 62B/301/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex A forms an integral part of this standard.
Annexes B and C are for information only.
The French version of this standard has not been voted upon.
1223-3-3 © IEC:1996 − 7 −
In this standard, the following print types are used:
− Requirements, compliance with which can be tested, and definitions: roman type;
– Explanations, advice, notes, general statements, exceptions and references: smaller type;
− Test specifications: italic type;
− TERMS DEFINED IN IEC 788 OR IN IEC 1223: SMALL CAPITALS (SEE ANNEX A).
1223-3-3 © IEC:1996 − 9 −
INTRODUCTION
This standard is part of a series of International Standards which give methods of acceptance
testing and constancy testing for subsystems and systems (e.g. diagnostic X-RAY EQUIPMENT),
including film processing, used in medical imaging departments.
1223-3-3 © IEC:1996 − 11 −
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –
Part 3-3: Acceptance tests –
Imaging performance of X-ray equipment
for digital subtraction angiography (DSA)
1 Scope and object
1.1 Scope
This part of IEC 1223 applies to those components of X-RAY EQUIPMENT which influence the
image quality of EQUIPMENT for digital subtraction angiography (DSA) with an imaging system
consisting of an X-ray generation subsystem, a detection device comprising an X-RAY IMAGE
INTENSIFIER television chain, means of digitization and digital image processing, image storage
and image manipulation including subtraction, and facilities for image display.
This standard does not apply to general equipment of digital imaging. If such an equipment
includes a DSA function, it is restricted to the DSA function.
1.2 Object
This part of IEC 1223 defines:
a) the essential parameters which describe the performance of the above-mentioned
components of X-RAY EQUIPMENT with regard to imaging properties;
b) methods of testing whether measured quantities related to those parameters comply with
specified tolerances.
These methods mainly rely on non-invasive measurements using appropriate test equipment
performed during the installation or after the installation is completed. Signed statements
covering steps in the installation procedure can be used as part of acceptance testing.
The aim is to verify compliance of the installation with specifications affecting the image quality,
and to detect malfunctions affecting the image quality that are not in agreement with those
specifications.
This standard does not in itself specify tolerances for the parameters under investigation.
Neither is it intended to consider:
c) aspects of mechanical and electrical safety;
d) aspects of mechanical, electrical and software performance unless they are essential to
the performance of the tests directly affecting the image quality.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 1223. At the time of publication, the editions indicated
were valid. All normative documents are subject to revision, and parties to agreements based
on this part of IEC 1223 are encouraged to investigate the possibility of applying the most
recent editions of the normative documents listed below. Members of IEC and ISO maintain
registers of currently valid International Standards.
1223-3-3 © IEC:1996 − 13 −
IEC 417N: 1995, Graphical symbols for use on equipment − Index, survey and compilation of
the single sheets – Thirteenth supplement
IEC 601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
IEC 601-1-3: 1994, Medical electrical equipment – Part 1: General requirements for safety –
3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray
equipment
IEC 601-2-7: 1987, Medical electrical equipment – Part 2: Particular requirements for the
safety of high-voltage generators of diagnostic X-ray generators
IEC 788: 1984, Medical radiology – Terminology
IEC 878: 1988, Graphical symbols for electrical equipment in medical practice
IEC 1223-1: 1993, Evaluation and routine testing in medical imaging departments – Part 1:
General aspects
IEC 1223-2-4: 1994, Evaluation and routine testing in medical imaging departments – Part 2-4:
Constancy tests – Hard copy cameras
IEC 1223-2-5: 1994, Evaluation and routine testing in medical imaging departments – Part 2-5:
Constancy tests – Image display devices
ISO 2092: 1981, Light metals and their alloys – Code of designation based on chemical
symbols
3 Terminology
3.1 Degree of requirements
In this part of IEC 1223, certain terms (which are not printed in SMALL CAPITALS) have particular
meanings, as follows:
– "shall" indicates a requirement that is mandatory for compliance;
– "should" indicates a strong recommendation that is not mandatory for compliance;
– "may" indicates a permitted manner of complying with a requirement or of
avoiding the need to comply;
– "specific" is used to indicate definitive information stated in this standard or
referenced in other standards, usually concerning particular operating
conditions, test arrangements or values connected with complianc
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.