IEC 61223-2-7:1999

Evaluation and routine testing in medical imaging departments - Part 2-7: Constancy tests - Equipment for intra-oral dental radiography excluding dental panoramic equipment

Describes a method to check, in terms of functional parameters, that the constancy of the quality of images produced by intra-oral dental X-ray equipment is maintained after installation, calibration and adjustment have been carried out. This standard defines: - the functional parameters, which describe the performance of X-ray equipment for intra-oral dental radiographic examination; - methods of checking, whether variations in measured functional parameters meet established criteria, in order to ensure that the conditions for adequate imaging performance are maintained, while unnecessary irradiation of the patient is avoided.

General Information

• Status: Withdrawn
• Publication Date: 15-Sep-1999
• Withdrawal Date: 06-Oct-2010
• ICS: 11.040.50 - Radiographic equipment
• ICS: 37.040.25 - Radiographic films
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Current Stage: WPUB - Publication withdrawn
• Completion Date: 28-May-2010

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
61223-2-7
First edition
1999-09
Evaluation and routine testing in
medical imaging departments –
Part 2-7:
Constancy tests –
Equipment for intra-oral dental radiography
excluding dental panoramic equipment
Essais d'évaluation et de routine dans
les services d'imagerie médicale –
Partie 2-7:
Essais de constance –
Appareils de radiographie dentaire intra-orale à l'exclusion
des appareils dentaires panoramiques

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
61223-2-7
First edition
1999-09
Evaluation and routine testing in
medical imaging departments –
Part 2-7:
Constancy tests –
Equipment for intra-oral dental radiography
excluding dental panoramic equipment
Essais d'évaluation et de routine dans
les services d'imagerie médicale –
Partie 2-7:
Essais de constance –
Appareils de radiographie dentaire intra-orale à l'exclusion
des appareils dentaires panoramiques

 IEC 1999  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: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 61223-2-7 © IEC:1999(E)
CONTENTS
Page
FOREWORD . 3

Clause
1 Scope and object . 5

1.1 Scope . 5

1.2 Object. 5
2 Normative references. 6
3 Terminology. 7
3.1 Degree of requirements . 7
3.2 Use of terms . 7
3.3 Definitions . 7
4 General aspects of CONSTANCY TESTS. 8
4.1 General conditions affecting test procedures . 8
4.2 Establishment of BASELINE VALUES. 9
4.3 Frequency of CONSTANCY TESTS. 9
4.4 Identification of equipment, instrumentation and test conditions . 9
4.5 Measured functional parameters . 10
5 Performance tests. 10
5.1 Test equipment . 10
5.2 Test procedures. 11
5.3 Data evaluation. 11
5.4 Criteria to be applied . 12
5.5 Action to be taken. 12
6 Statement of compliance. 13
Annex A (normative) Terminology – Index of defined terms. 15
Annex B (informative) Example of a form for the standardized test report. 17
Annex C (informative) Guidance on action to be taken . 19

Annex D (informative) Possible faults and corrective actions . 20
Figure 1 – Measuring arrangement for intra-oral dental RADIOGRAPHY. 14

61223-2-7 © IEC:1999(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS –

Part 2-7: Constancy tests –
Equipment for intra-oral dental radiography

excluding dental panoramic 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 61223-2-7 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/370/FDIS 62B/382/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, C and D are for information only.

– 4 – 61223-2-7 © IEC:1999(E)
This standard forms part 2-7 of IEC 61223, which will include the following parts:

Part 1: General aspects
Part 2-1: Constancy tests – Film processors

Part 2-2: Constancy tests – Radiographic cassettes and film changers – Film-screen contact

and relative sensitivity of the screen-cassette assembly

Part 2-3: Constancy tests – Darkroom safelight conditions

Part 2-4: Constancy tests – Hard copy cameras

Part 2-5: Constancy tests – Image display devices

Part 2-6: Constancy tests – X-ray equipment for computed tomography
Part 2-7: Constancy tests – Equipment for intra-oral dental radiography excluding dental
panoramic equipment
Part 2-9: Constancy tests – Equipment for indirect radioscopy and indirect radiography
Part 2-10: Constancy tests – X-ray equipment for mammography
Part 2-11: Constancy tests – Equipment for general direct radiography
The committee has decided that this publication remains valid until 2003.
At this date, in accordance with the committee’s decision, 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.

61223-2-7 © IEC:1999(E) – 5 –
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS –

Part 2-7: Constancy tests –
Equipment for intra-oral dental radiography

excluding dental panoramic equipment

1 Scope and object
1.1 Scope
This part of IEC 61223 applies to RADIOLOGICAL INSTALLATIONS with diagnostic X-ray systems
designed to expose intra-orally placed radiographic films or electronic equipment (sensors),
but excluding dental panoramic equipment.
This standard is a part of a series of Particular Publications (standards and technical reports),
which give methods of tests for the constancy of operation of various subsystems of
diagnostic X-RAY EQUIPMENT.
This part of IEC 61223 is designed to be applicable to equipment for intra-oral dental
radiography without digital imaging devices.
1.2 Object
This standard describes a method to check, in terms of functional parameters, that the
constancy of the quality of images produced by intra-oral dental X-RAY EQUIPMENT is
maintained after installation, calibration and adjustment have been carried out.
This standard defines
– the functional parameters, which describe the performance of X-RAY EQUIPMENT for intra-
oral dental radiographic examination;
– methods of checking, whether variations in measured functional parameters meet
ESTABLISHED CRITERIA, in order to ensure that the conditions for adequate imaging
performance are maintained, while unnecessary IRRADIATION of the PATIENT is avoided.
The methods are based upon assessment of radiographic information using an appropriate
TEST DEVICE.
The purpose of the methods is
– to establish a reference level of performance following an ACCEPTANCE TEST and an initial
CONSTANCY TEST;
– to detect and verify any significant variation in functional parameters which may then
require corrective actions.
Because RADIOLOGICAL INSTALLATIONS differ widely from each other, it is not possible in this
standard to specify target values and tolerances for the parameters which would be generally
applicable as criteria of acceptable performance. Guidance is given, however, as to the
degree of variation in single measurements which might require appropriate action.
This standard gives methods of tests for the constancy of properties of diagnostic X-RAY
EQUIPMENT as described in IEC 61223-1 (see clause 2).

– 6 – 61223-2-7 © IEC:1999(E)
This standard is not intended to deal with:

– aspects of mechanical or electrical safety;

– checks of the effectiveness of the direct means of protection against X-RADIATION;

– optimization of imaging performance.

In general, the use of a densitometer to check the optical densities is recommended.

However, for simplicity, in this standard only the use of a simple TEST DEVICE and the visual

comparison of a UNIFORM CONSTANCY TEST FILM with a reference INITIAL CONSTANCY TEST FILM is

regarded as sufficient.
With regard to the measurements, reference is made to methods described in related
publications which, for practical reasons, should be carried out prior to the application of the
methods described in this standard (see clause 2).
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 amend-
ments 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 60788:1984, Medical radiology – Terminology
IEC 61223-1:1993, Evaluation and routine testing in medi
...