IEC 61223-3-4:2000
(Main)Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
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
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.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch 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 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 60601-1, IN IEC 60788, IN IEC 61223-1 OR IN OTHER IEC PUBLICATIONS
REFERENCED IN ANNEX A: SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged
until 2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this standard may be issued at a later date.
– 6 – 61223-3-4 © IEC:2000(E)
INTRODUCTION
This part of IEC 61223 is part of a series of International Standards which gives methods of
acceptance testing and constancy testing for subsystems and systems (for example, diagnostic
X-RAY EQUIPMENT) including film processing.
Some provisions or statements in this standard require additional information. Such information
is presented in annex B. An asterisk in the left margin of a clause or subclause indicates the
presence of such additional information.
61223-3-4 © IEC:2000(E) – 7 –
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –
Part 3-4: Acceptance tests –
Imaging performance of dental X-ray equipment
1 Scope and object
1.1 Scope
This part of IEC 61223 applies to those components of dental X-RAY EQUIPMENT using
radiographic imaging systems which influence the image quality and PATIENT dose.
ACCEPTANCE TEST RAY EQUIPMENT
This standard applies to the performance of the on dental X-
RAY IMAGE RECEPTOR RAY EQUIPMENT RAY IMAGE
with intra-oral X- and dental X- with extra-oral X-
RECEPTOR (for example, dental panoramic X-RAY EQUIPMENT or cephalometric X-RAY).
This standard applies to dental film and digital image acquisition and processing.
1.2 Object
This standard defines
a) the essential parameters which describe the performance of the above-mentioned dental
X-RAY EQUIPMENT with regard to imaging properties and PATIENT dose;
b) methods of testing and whether measured quantities related to those parameters comply
with the specified tolerances.
These methods rely mainly on non-invasive measurements, using appropriate test equipment,
performed during or after the installation is completed. Signed statements covering steps in the
installation procedure may be used as part of the acceptance testing.
The aim is to verify compliance of the installation with specifications affecting the image quality
and PATIENT dose, and to detect malfunctions 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 image quality and PATIENT dose.
– 8 – 61223-3-4 © IEC:2000(E)
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 61223. For dated references, subsequent amendments
to, or revisions of, any of these publications do not apply. However, parties to agreements
based on this part of IEC 61223 are encouraged to investigate the possibility of applying the
most recent editions of the normative documents indicated below. For undated references, the
latest edition of the normative document referred to applies. Members of IEC and ISO maintain
registers of currently valid International Standards.
IEC 60336:1993,
X-ray tube assemblies for medical diagnosis – Characteristics of focal spots
IEC 60417-1:1998,
Graphical symbols for use on equipment – Part 1: Overview and application
IEC 60417-2:1998,
Graphical symbols for use on equipment – Part 2: Symbol originals
IEC 60522:1999, Determination of the permanent filtration of X-ray tube assemblies
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-2-28:1993, Medical electrical equipment – Part 2-28: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60788:1984, Medical radiology – Terminology
IEC 60878:1988, Graphical symbols for electrical equipment in medical practice
IEC 61223-1:1993, Evaluation and routine testing in medical imaging departments – Part 1:
General aspects
IEC 61267:1994, Medical diagnostic X-ray equipment – Radiation conditions for use in the
determination of characteristics
ISO 2092:1981, Light metals and their alloys – Code of designation based on chemical symbols
3 Terminology
3.1 Degree of requirements
In this standard, 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 compliance;
– "specified" is used to indicate definitive information stated by the MANUFACTURER in
ACCOMPANYING DOCUMENTS EQUIPMENT
or in other documentation relating to the
under consideration, usually concerning its intended purposes, or the para-
meters or conditions associated with its use or with testing to determine
compliance.
61223-3-4 © IEC:2000(E) – 9 –
3.2 Use of terms
In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions
in IEC 60601-1, in IEC 60788, in IEC 61223-1, or in this standard.
NOTE Attention is drawn to the fact that in cases where the concept addressed is not strongly confined to the
definition given in one of the publications listed above, a corresponding term is printed in lower-case letters.
An index of defined terms used in this standard is given in annex A.
3.3 Defined terms
For the purpose of this part of IEC 61223, the following additional definitions apply.
3.3.1
ARTEFACT
apparent structure visible in the image which does not represent a structure within the object.
3.3.2
LINE PAIR RESOLUTION
highest spatial frequency of the specified line-group test pattern imaged under specified
conditions which is distinguishable in the image. The unit is lp/mm.
NOTE Another term for LINE PAIR RESOLUTION used in literature is spatial resolution.
3.3.3
LOW CONTRAST RESOLUTION
the lowest contrast detail object of a specified object that can be resolved from a uniform
background.
3.3.4
RADIATION OUTPUT
AIR KERMA per CURRENT TIME PRODUCT (mGy/mAs) at a given distance from the FOCAL SPOT in
the primary X-RAY BEAM.
4 General aspects of ACCEPTANCE TESTS
4.1 General conditions to be considered in test procedures
The aim of an ACCEPTANCE TEST is to demonstrate that the specified characteristics of the
EQUIPMENT
lie within the specified tolerances. Some requirements are enforced by legislation.
Other requirements and specifications may be in the purchase contract, in the supplier's
brochure or in other standards, for example in the IEC 60601 series.
An inventory of the EQUIPMENT under test, the ACCOMPANYING DOCUMENTS, and the test
protocols, shall be compiled before any ACCEPTANCE TESTS are carried out. Each item shall be
identified by its MODEL OR TYPE REFERENCE (type number) and SERIAL NUMBER, and the entire
inventory shall be compared with the purchase contract.
The response of non-screen dental X-ray film (NON-SCREEN FILM, rm-32-35) to a visible-light
RADIATION
sensitometer does not match its response to X- . It is therefore most practicable to
EQUIPMENT
assess the performance of a dedicated dental film processing system when is
available for testing the X-RAY EQUIPMENT. A suitable test procedure is given in annex C.
– 10 – 61223-3-4 © IEC:2000(E)
RADIOGRAPHIC FILMS and film processing are vital parts in the imaging chain. It is the
responsibility of the USER to ensure that these components perform in an acceptable way, for
example with respect to sensitivity, contrast and absence of ARTEFACTS. A test of the
performance of these components shall precede any ACCEPTANCE TEST measurements
involving the IRRADIATION of RADIOGRAPHIC FILMS using the dental X-RAY EQUIPMENT.
The performance of the IMAGE DISPLAY DEVICE will affect the measured performance of a digital
dental imaging system. Before any ACCEPTANCE TESTS are carried out on the X-RAY EQUIPMENT,
IMAGE DISPLAY DEVICE MANUFACTURER S
the shall be set up, by following the ' instructions and
using the MANUFACTURER'S electronic test image, to deliver its specified performance.
Non-invasive measurements are preferred for ACCEPTANCE TESTS. Whenever invasive tests are
part of the programme it shall be shown that the EQUIPMENT has been restored to its pre-test
condition after the test.
4.2 Documents and data for the tests
The following documentation is required:
– statement of compliance with applicable parts of IEC 60601;
– list of EQUIPMENT or EQUIPMENT parts ordered and the actual delivery list (IEC 60601-1);
– performance specification as agreed upon between the purchaser and the supplier;
MANUFACTURER
– results from tests performed at the 's site or during installation covering
items of importance to quality, such as NOMINAL FOCAL SPOT VALUE;
– INSTRUCTIONS FOR USE, including guidance for the operation of the EQUIPMENT;
– details of the actual operating conditions under which the dental X-RAY EQUIPMENT is to be
used;
– guidance as to the extent and frequency of maintenance procedures;
– reports on previous tests where applicable;
– data on technical changes.
4.3 Test conditions
Different categories of tests can be identified:
– visual inspection;
– functional tests;
– system performance;
– check of the uncertainty in the values of variables.
The measuring arrangements which may be used for performing tests are illustrated,
a) for intra-oral application (see figures 1 and 2);
b) for panoramic application (see figures 3 and 4);
c) for cephalometric application (see figure 5).
The arrangement in figure 1 is indicative only. Not every component is needed in every test.
61223-3-4 © IEC:2000(E) – 11 –
The tests shall yield information reasonably necessary for a demonstration of performance over
the full range of OPERATOR accessible variables.
All relevant data such as the identification of the dental X-RAY EQUIPMENT tested, identification
of the test equipment used, geometrical set-up, operating characteristics, correction factors
and test results of the ASSOCIATED EQUIPMENT (RADIOGRAPHIC FILM, processing), shall be
recorded with the test results. The record shall include the identification of the location, the
date and the names of the persons performing the tests.
4.4 Scope of tests
ACCEPTANCE TESTING
The following are subject to :
– identification of dental X-RAY EQUIPMENT;
– check of documents;
– visual and functional tests;
–X-RAY TUBE VOLTAGE;
– TOTAL FILTRATION;
– FOCAL SPOT;
– limitation and alignment of the X-RAY BEAM;
– LINE PAIR RESOLUTION;
– LOW CONTRAST RESOLUTION;
RADIATION OUTPUT
– ;
– optical density.
4.5 Test equipment including PHANTOMS and TEST DEVICES
4.5.1 General
Measuring equipment used for ACCEPTANCE TESTS shall be certified as calibrated against a
national standard or an International Standard where such a standard exists.
The uncertainty of measuring instruments shall be less than the tolerance stated for the
MEASURED VALUES.
4.5.2 High-voltage measuring instrument
Wherever practicable, the X-RAY TUBE VOLTAGE should be measured by a radiographic
penetrameter.
NOTE If it is necessary to use an electronic high-voltage measuring instrument, the USER should evaluate the
significance of any deviation between the INDICATED VALUES and MEASURED VALUES.
RAY EQUIPMENT RAY TUBE VOLTAGE
In some types of dental X- , there is a variation of X- at the
beginning of the LOADING TIME, which is of no clinical consequence.
Some panoramic equipment is designed so that the X-RAY TUBE VOLTAGE is deliberately varied
during the LOADING TIME.
No general guidance can be given as different types of "digital kV meter" respond to different
aspects of the voltage/time characteristic.
– 12 – 61223-3-4 © IEC:2000(E)
4.5.3 KERMAMETER
Dental radiography uses X-RAY BEAMS with smaller dimensions, lower energy and lower AIR
KERMA RATES than general medical radiography. It shall be ensured that the KERMAMETER used
for these tests is suitable for the purpose and calibrated for the energy and KERMARATE in use
and that the detector is smaller than the nominated beam dimensions.
HANTOMS TEST DEVICES
4.5.4 P and
These TEST DEVICES may consist of structural elements which can be arranged in combination
or separately.
The test device shall contain a grid group with a spatial frequency equal to, or higher than, the
spatial frequency to be resolved. The following requirements apply:
a) External dimensions
The dimensions of these PHANTOMS shall be at least large enough to intercept the entire
RADIATION BEAM for all test conditions applicable:
1) for intra-oral application (see figures 6 and 7);
2) for panoramic application;
3) for cephalometric application.
b) ATTENUATION and hardening
PHANTOMS
The aluminium shall be of at least 99,5 % purity (Al 99,5 % according to
ISO 2092) and a material thickness of 6 mm ± 0,1 mm (see IEC 61267).
c) TEST DEVICE for LINE PAIR RESOLUTION for digital imaging
Suitable TEST DEVICES may comprise line-group test patterns with a lead thickness of
0,05 mm and grid groups with local frequencies
1) for intra-oral application of 4,0 lp/mm to 8,0 lp/mm
2) for panoramic application of 1,6 lp/mm to 3,0 lp/mm
3) for cephalometric application of 1,6 lp/mm to 3,0 lp/mm
with a gradation of 20 % from group to group.
≤
d) TEST DEVICE for LOW CONTRAST RESOLUTION for digital imaging
TEST DEVICE
The shall contain one minimal contrast object with a contrast lower or equal to
TEST DEVICE
the contrast to be detected. A suitable is one with holes in a 0,5 mm Al foil
(see figure 7):
1) for intra-oral application, 1 mm, 1,5 mm, 2 mm, 2,5 mm diameter;
2) for panoramic application, 1 mm, 1,5 mm, 2 mm, 2,5 mm diameter;
3) for cephalometric application, 1 mm, 1,5 mm, 2 mm, 2,5 mm diameter.
4.5.5 Lens
A magnifying lens shall be available. A 2,5 magnification is usually suitable.
×
4.5.6 Densitometer
The densitometer shall cover the optical density range from 0 to 3,5.
61223-3-4 © IEC:2000(E) – 13 –
4.6 Evaluating the test results
Whenever specified limiting values or tolerances are exceeded, verify the results by making at
least two additional measurements.
In the evaluation of the results concerning limit values (upper or lower), the uncertainty in the
measurement shall be taken into consideration.
5 Test methods for dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR
5.1 Visual and functional tests
5.1.1 Requirements
RAY EQUIPMENT
The operation and functioning of the dental X- shall comply with what is
specified.
All OPERATOR accessible controls shall be labelled with a graphical symbol, for example
according to IEC 60417 or IEC 60878, and/or in plain language. The colour of indicator lamps
shall comply with applicable standards, for example IEC 60601-1. The marking on the X-RAY
TUBE ASSEMBLY shall comply with IEC 60601-2-28.
The INSTRUCTIONS FOR USE shall describe comprehensively how the dental X-RAY EQUIPMENT
under test is to be operated. The function of each OPERATOR accessible control, indicator and
DISPLAY shall be described and all symbols shall be illustrated with their significance.
Reproductions in the INSTRUCTIONS FOR USE shall be in agreement with the actual dental X-RAY
EQUIPMENT, with respect to position, labels and symbols. The INSTRUCTIONS FOR USE shall be in
the language that is required locally.
5.1.2 Test methods
The tests are performed by visual inspection and functional check. They comprise
– inventory of EQUIPMENT under test;
– check on the presence of all documents according to 4.2;
– functional test of the mechanical and electrical adjustment devices;
– functional test and identification of the control elements;
– visual inspection of the labelling of control elements;
– visual inspection of the markings on the X-RAY TUBE ASSEMBLY;
– visual inspection of the INSTRUCTIONS FOR USE (according to IEC 60601-1).
5.2 *X-RAY TUBE VOLTAGE
5.2.1 Requirement
The MEASURED VALUES for the X-RAY TUBE VOLTAGE shall comply with the INDICATED VALUES
within the specified tolerances.
5.2.2 Test methods
The measurements shall be carried out with the arrangement in figure 1. The tests are
preferably performed using a non-invasive method.
– 14 – 61223-3-4 © IEC:2000(E)
Place the penetrameter or the detector of the high-voltage measuring instrument in the centre
of the PRIMARY RADIATION BEAM at the IMAGE RECEPTOR PLANE.
Make the measurements at the fixed X-RAY TUBE VOLTAGES or at the X-RAY TUBE VOLTAGE
normally used.
MEASURED VALUES RAY TUBE VOLTAGE INDICATED VALUES
Compare the of the X- with the and the
specified tolerances.
OTAL FILTRATION
5.3 *T
5.3.1 Requirements
TOTAL FILTRATION RAY BEAM PATIENT
The arising from materials in the X- incident to the shall be
as specified. The TOTAL FILTRATION is stated as QUALITY EQUIVALENT FILTRATION in thickness of
aluminium or other suitable reference material, together with the RADIATION QUALITY used for its
determination.
5.3.2 Test method
The compliance with the specification is checked by inspection of the markings on the X-RAY
SOURCE ASSEMBLY and by examination of the ACCOMPANYING DOCUMENTS. If this information is
TOTAL FILTRATION QUALITY EQUIVALENT FILTRATION
not given, the is not measured directly but the
is determined according to clauses 3 and 4 of IEC 60522, if necessary (see below).
NOTE This requires measuring the HALF VALUE LAYER under NARROW BEAM CONDITIONS with the dental X-RAY
EQUIPMENT operating at fixed values of X-RAY TUBE VOLTAGE and corresponding LOADING FACTORS, and for
comparison with the HALF-VALUE LAYER from an X-RAY TUBE with the same TARGET material and TARGET angle.
A simplified measurement may be carried out with the arrangement in figure 1. Measure the
first HALF VALUE LAYER with the dental X-RAY EQUIPMENT operating at the fixed X-RAY TUBE
VOLTAGE and the CURRENT TIME PRODUCT normally used. This test gives only an approximation
of the TOTAL FILTRATION because these test conditions do not comply with IEC 60522. Failure of
compliance shown by this modified measurement shall not be used as a reason for non-
RAY EQUIPMENT
acceptance of the dental X- . It is only valuable as indicating the need for a more
rigorous test.
OCAL SPOT RAY TUBE
5.4 *F of the X-
5.4.1 Requirements
ACTUAL FOCAL SPOT NOMINAL FOCAL SPOT VALUE
The dimensions for the stated shall comply with
IEC 60336. Additional specifications, for example concerning dimensions, direction of the
REFERENCE AXIS or LOADING FACTORS, are subject to testing within the scope of this standard
only if these specifications also state the method of testing.
5.4.2 Test method
The compliance of the ACTUAL FOCAL SPOT dimensions for the stated NOMINAL FOCAL SPOT VALUE
with IEC 60336 shall be certified and demonstrated by the MANUFACTURER.
NOTE FOCAL SPOT measuring procedures by SLIT CAMERA, PINHOLE CAMERA, star-pattern, evaluation, and Fourier
transform of images of TEST DEVICES all give different results concerning size and resolution. The standard FOCAL
SPOT measurement is specified according to IEC 60336 by SLIT CAMERA under specified projection conditions and
optical density. The inspection procedure may be specified in the purchase contract.
61223-3-4 © IEC:2000(E) – 15 –
5.5 Limitation and alignment of the X-RAY BEAM
5.5.1 Requirements
The accuracy of marked and written indications of the size of the X-RAY FIELD on the EQUIPMENT
and the actual size of the X-RAY FIELD shall comply with the tolerances specified.
5.5.2 Test methods
Compliance is checked by inspection of the X-RAY EQUIPMENT and by examination of the
ACCOMPANYING DOCUMENTS. Measure the dimensions of the X-RAY FIELD at the end of the dental
BEAM APPLICATOR
.
RADIOGRAM REFERENCE AXIS BEAM
Examine the and evaluate whether or not the and the
LIMITING DEVICE are aligned correctly.
NOTE For a circular beam-limiting device and dental beam applicator, there will be a change in the optical density
across the image of the radiogram when the reference axis is not parallel to the dental beam applicator. Also when
the beam-limiting device is not aligned correctly with the reference axis at the radiation head, the image on the
radiogram will appear oval in shape.
Make the measurements with a RADIOGRAPHIC FILM (dental film) in a lightproof envelope or a
RADIOGRAPHIC CASSETTE or a suitable X-RAY IMAGE RECEPTOR arranged at the end of the DENTAL
BEAM APPLICATOR and the arrangement in figure 1.
Produce RADIOGRAMS under these conditions with LOADING FACTORS so as to give on the
RADIOGRAPHIC FILM
processed an optical density D in the range 0,5 to 2,0.
RAY FIELD
Measure the X- size and note any discrepancies from the specified value. If there is
no film-processing available, it is possible to test the limitation of the X-ray beam with the
digital sensor by taking four exposures at 90° rotation.
The discrepancies between the measured X-RAY FIELD size and the specified value shall be
within the specified tolerances.
5.6 FOCAL SPOT TO SKIN DISTANCE
5.6.1 Requirement
The accuracy of marked and written indications of the distance from the indicated FOCAL SPOT
DENTAL BEAM APPLICATOR
to the end of the shall comply with the tolerances specified.
5.6.2 Test methods
RAY EQUIPMENT
Compliance is checked by inspection of the X- and by examination of the
ACCOMPANYING DOCUMENTS.
Measure the distance from the FOCAL SPOT to the end of the DENTAL BEAM APPLICATOR.
The discrepancies between the measured distance and the indications shall be within the
specified tolerances.
– 16 – 61223-3-4 © IEC:2000(E)
5.7 *Reproducibility of RADIATION OUTPUT
5.7.1 Requirements
The reproducibility of the AIR KERMA with the CURRENT TIME PRODUCT shall comply with the
tolerances or values specified.
5.7.2 Test method
Make the measurements with the arrangement in figure 1. The detector of the KERMAMETER is
placed in the PRIMARY RADIATION BEAM close to the DENTAL BEAM APPLICATOR. Ensure that
RADIATION OUTPUT
the beam completely covers the detector. Measure the reproducibility of the
RAY TUBE VOLTAGES CURRENT TIME PRODUCT
at the specified X- and the normally used preferably
3 mAs to 5 mAs.
NOTE Dental X-RAY EQUIPMENT is designed for use at very low duty cycles. Sufficient cooling time should be
allowed between test IRRADIATIONS for the system to remain within its operating temperature limits, and to ensure
that the results represent the intended performance of the EQUIPMENT. If the MANUFACTURER's instructions do not
LOADING TIME
specify a duty cycle, restrict the to less than 0,5 s per minute.
The suggested LOADING TIME has been chosen so that initial transient effects, and the effects of heating during the
IRRADIATION
, should not affect the result.
Make at least five measurements of AIR KERMA at the specific combination of CURRENT TIME
PRODUCT and X-RAY TUBE VOLTAGE.
Calculate the mean value and the coefficient of variation and check whether all individual
measurements are in the specified range.
Compare the results of these calculations with the specified tolerances.
INE PAIR RESOLUTION
5.8 L
a) Without digital imaging acquisition or processing parts
NOTE There is no requirement and no test included here because the LINE PAIR RESOLUTION is either
determined by the FOCAL SPOT SIZE (see 5.4) and the geometry or limited by the characteristic of the film type
used.
b) With digital imaging acquisition or processing parts
With the arrangement of figure 2, vary the IRRADIATION TIME setting to obtain an IRRADIATION
in the detector plane that is recommended by the MANUFACTURER to produce the maximum
dynamic range in the image.
Use this IRRADIATION TIME setting to produce an image of the TEST DEVICE shown in figure 7.
LINE PAIR RESOLUTION
Compare the with the specified value.
OW CONTRAST RESOLUTION
5.9 L
a) Without digital imaging acquisition or processing parts
Not applicable.
b) With digital imaging acquisition or processing parts
The test image generated in 5.8 b) includes low contrast steps. Note the value of the lowest
contrast step that is discernible from its background, and compare this with the specified
value.
61223-3-4 © IEC:2000(E) – 17 –
6 Test methods for dental panoramic X-RAY EQUIPMENT with extra-oral X-RAY
IMAGE RECEPTOR
6.1 Visual and functional tests
The requirements and tests given in 5.1 are applicable.
6.2 X-RAY TUBE VOLTAGE
6.2.1 Requirements
The requirements given in 5.2 are applicable.
6.2.2 Test method
Either a penetrameter or the detector of a suitable high-voltage measuring instrument may be
attached to the secondary diaphragm or to the digital sensor.
OTAL FILTRATION
6.3 T
6.3.1 Requirements
TOTAL FILTRATION RAY BEAM PATIENT
The arising from materials in the X- incident to the shall be
as specified. The TOTAL FILTRATION is stated as QUALITY EQUIVALENT FILTRATION in thickness of
aluminium or other suitable reference material, together with the RADIATION QUALITY used for its
determination.
6.3.2 Test method
The compliance with the specification is checked by inspection of the markings on the X-RAY
SOURCE ASSEMBLY and by examination of the ACCOMPANYING DOCUMENTS. If this information is
not given, the TOTAL FILTRATION is not measured directly, but the QUALITY EQUIVALENT
FILTRATION
is determined according to clauses 3 and 4 of IEC 60522, if necessary (see below).
NOTE This requires measuring the HALF VALUE LAYER under NARROW BEAM CONDITIONS with the dental X-RAY
EQUIPMENT operating at values of X-RAY TUBE VOLTAGE and corresponding LOADING FACTORS, and for comparison
with the HALF-VALUE LAYER from an X-RAY TUBE with the same TARGET material and TARGET angle.
A simplified measurement may be carried out with the arrangement in figure 1. Measure the
first HALF VALUE LAYER with the dental X-RAY EQUIPMENT operating at the X-RAY TUBE VOLTAGE
and the CURRENT TIME PRODUCT normally used. This test gives only an approximation of the
TOTAL FILTRATION because these test conditions do not comply with IEC 60522. Failure of
compliance shown by this modified measurement shall not be used as a reason for non-
RAY EQUIPMENT
acceptance of the dental X- . It is only valuable as indicating the need for a more
rigorous test.
OCAL SPOT RAY TUBE
6.4 F of the X-
The requirements and test methods of 5.4 are applicable.
6.5 Limitation and alignment of the X-RAY BEAM
6.5.1 Requirements
The accuracy of marked and written indications of the size of the X-RAY FIELD on the dental
X-RAY EQUIPMENT and the actual size of the X-RAY FIELD and the alignment shall comply with
the tolerances specified.
– 18 – 61223-3-4 © IEC:2000(E)
6.5.2 Test methods
One applicable test procedure is listed below.
Compliance is checked by inspection of the dental X-RAY EQUIPMENT and by examination of the
ACCOMPANYING DOCUMENTS. Measure the dimensions of the slot in the secondary DIAPHRAGM.
Make the measurement with RADIOGRAPHIC FILM in lightproof envelopes or a suitable X-RAY
IMAGE RECEPTOR DIAPHRAGM
placed both in front of and behind the secondary with the
RAY IMAGE RECEPTORS
arrangement in figure 3. Ensure that the X- extend several centimetres
above and below the slot in the secondary DIAPHRAGM and that there will be no interference
with the rotational movement of the dental panoramic X-RAY EQUIPMENT. Produce RADIOGRAMS
using suitable LOADING FACTORS so as to give on the processed film an optical density D in the
range 0,5 to 2,0.
Measure the X-RAY FIELD size on the film from in front of the secondary DIAPHRAGM and note
the discrepancies from the specified value. The discrepancies between the measured X-RAY
FIELD
size and the specified value shall be within the specified tolerances.
RAY FIELD DIAPHRAGM
Measure the X- size on the film from behind the secondary and note the
discrepancies from the specified value and the dimensions of the slot in the secondary
DIAPHRAGM. Examine the film and ensure that the alignment of the X-RAY BEAM and the slot in
the secondary DIAPHRAGM are satisfactory. The discrepancies between the measured X-RAY
FIELD size and the specified value shall be within the specified tolerances.
6.6 FOCAL SPOT TO SKIN DISTANCE
No requirements for this test.
6.7 Reproducibility of RADIATION OUTPUT
If the RADIATION OUTPUT is possible in both clockwise and counter-clockwise directions then the
reproducibility needs to be measured using both directions.
6.7.1 Requirements
The reproducibility of the AIR KERMA with the CURRENT TIME PRODUCT shall comply with the
tolerances or values specified.
6.7.2 Test method
Make the measurements with the arrangement in figure 3. The detector of the KERMAMETER is
placed in the PRIMARY RADIATION BEAM close to the secondary
...
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