IEC 61223-3-4:2000

Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment

Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.

General Information

• Status: Published
• Publication Date: 20-Mar-2000
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 23 - TC 62/SC 62B/WG 23
• Current Stage: PPUB - Publication issued
• Start Date: 30-Apr-2000
• Completion Date: 21-Mar-2000

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
61223-3-4
First edition
2000-03
Evaluation and routine testing in medical
imaging departments –
Part 3-4:
Acceptance tests –
Imaging performance of dental X-ray equipment
Essais d'évaluation et de routine dans les services
d'imagerie médicale –
Partie 3-4:
Essais d'acceptation –
Performance d'imagerie des appareils
de radiographie dentaire
Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are
available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base
publication incorporating amendments 1 and 2.
Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
61223-3-4
First edition
2000-03
Evaluation and routine testing in medical
imaging departments –
Part 3-4:
Acceptance tests –
Imaging performance of dental X-ray equipment
Essais d'évaluation et de routine dans les services
d'imagerie médicale –
Partie 3-4:
Essais d'acceptation –
Performance d'imagerie des appareils
de radiographie dentaire
 IEC 2000  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
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Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
V
International Electrotechnical Commission
For price, see current catalogue

– 2 – 61223-3-4 © IEC:2000(E)
CONTENTS
Page
FOREWORD 4
..........................................................................................................................
INTRODUCTION 6
....................................................................................................................
Clause
1 Scope and object 7
.............................................................................................................
1.1 Scope 7
.....................................................................................................................
1.2 Object 7
.....................................................................................................................
2 Normative references 8
.......................................................................................................
3 Terminology 8
.....................................................................................................................
3.1 Degree of requirements 8
...........................................................................................
3.2 Use of terms 9
...........................................................................................................
3.3 Defined terms 9
.........................................................................................................
4 General aspects of ACCEPTANCE TESTS 9
.............................................................................
4.1 General conditions to be considered in test procedures 9
...........................................
4.2 Documents and data for the tests 10
..........................................................................
4.3 Test conditions 10
......................................................................................................
4.4 Scope of tests 11
.......................................................................................................
4.5 Test equipment including PHANTOMS and TEST DEVICES 11
..........................................
4.6 Evaluating the test results 13
.....................................................................................
5 Test methods for dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR 13
.............
5.1 Visual and functional tests 13
.....................................................................................
5.2 *X-RAY TUBE VOLTAGE 13
............................................................................................
OTAL FILTRATION
5.3 *T 14
.................................................................................................
5.4 *FOCAL SPOT of the X-RAY TUBE 14
..............................................................................
5.5 Limitation and alignment of the X-RAY BEAM 15
...........................................................
5.6 FOCAL SPOT TO SKIN DISTANCE 15
................................................................................
5.7 *Reproducibility of RADIATION OUTPUT 16
.....................................................................
5.8 LINE PAIR RESOLUTION 16
............................................................................................
OW CONTRAST RESOLUTION
5.9 L 16
...................................................................................
RAY EQUIPMENT RAY IMAGE
6 Test methods for dental panoramic X- with extra-oral X-
RECEPTOR 17
.......................................................................................................................
6.1 Visual and functional tests 17
.....................................................................................
6.2 X-RAY TUBE VOLTAGE 17
..............................................................................................
6.3 TOTAL FILTRATION 17
..................................................................................................
6.4 FOCAL SPOT of the X-RAY TUBE 17
...............................................................................
RAY BEAM
6.5 Limitation and alignment of the X- 17
...........................................................
6.6 FOCAL SPOT TO SKIN DISTANCE 18
................................................................................
6.7 Reproducibility of RADIATION OUTPUT 18
......................................................................
6.8 LINE PAIR RESOLUTION 19
............................................................................................
6.9 LOW CONTRAST RESOLUTION 19
...................................................................................
6.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING SCREENS 19
.......................................
6.11 Image homogeneity 19
...............................................................................................
6.12 Indicators for patients' positioning 20
.........................................................................
6.13 Panoramic layer 20
....................................................................................................

61223-3-4 © IEC:2000(E) – 3 –
Clause Page
7 Test methods for dental cephalometric X-RAY EQUIPMENT with extra-oral X-RAY IMAGE
RECEPTOR 20
.......................................................................................................................
7.1 Visual and functional tests 20
.....................................................................................
7.2 X-RAY TUBE VOLTAGE 20
..............................................................................................
7.3 TOTAL FILTRATION 20
..................................................................................................
OCAL SPOT RAY TUBE
7.4 F of the X- 20
...............................................................................
7.5 Limitation and alignment of the X-RAY BEAM 20
...........................................................
7.6 FOCAL SPOT TO SKIN DISTANCE 21
................................................................................
7.7 Reproducibility of RADIATION OUTPUT 21
......................................................................
7.8 LINE PAIR RESOLUTION 21
............................................................................................
7.9 LOW CONTRAST RESOLUTION 21
...................................................................................
ADIOGRAPHIC FILM INTENSIFYING SCREENS
7.10 R cassettes with 21
.......................................
8 Test report and statement of compliance 21
........................................................................
Annex A (normative) Terminology – Index of defined terms 30
..................................................
Annex B (informative) Examples of requirements (accuracy, tolerances, discrepancies)
according to actual IEC standards or state of the art 32
.............................................................
Annex C (informative) ACCEPTANCE TEST for processing of non-screen dental X-ray films
(non-screen film) 34
..................................................................................................................
Bibliography 35
.........................................................................................................................
RAY EQUIPMENT RAY IMAGE RECEPTOR
Figure 1 – Dental X- with intra-oral X- measuring
arrangement for AIR KERMA and resolution 23
.............................................................................
Figure 2 – Dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR measuring
arrangement for AIR KERMA and resolution 24
.............................................................................
Figure 3 – Dental panoramic X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR
measuring arrangement for AIR KERMA and resolution 25
............................................................
Figure 4 – Example of a dental panoramic X-RAY EQUIPMENT with extra-oral digital X-RAY
IMAGE RECEPTOR measuring arrangement for AIR KERMA, resolution, image homogenity
and panoramic layer 26
.............................................................................................................
Figure 5 – Example of a cephalometric X-RAY EQUIPMENT with extra-oral X-RAY
IMAGE RECEPTOR AIR KERMA
measuring arrangement for and resolution 27
..................................
Figure 6 – Dental PHANTOM (example) 28
...................................................................................
Figure 7 – Dental PHANTOM for digital image acquisition or processing parts (example) 29
..........
Table B.1 – Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES 32
..........
– 4 – 61223-3-4 © IEC:2000(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –
Part 3-4: Acceptance tests –
Imaging performance of dental X-ray equipment
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 specifications, 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 61223-3-4 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/393/FDIS 62B/402/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annex A forms an integral part of this standard.
Annexes B and C are for information only.

61223-3-4 © IEC:2000(E) – 5 –
In this standard, the following pri
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