IEC 61223-3-1:1999

INTERNATIONAL IEC
STANDARD
61223-3-1
First edition
1999-03
Evaluation and routine testing
in medical imaging departments –
Part 3-1:
Acceptance tests –
Imaging performance of X-ray equipment
for radiographic and radioscopic systems
Essais d'évaluation et de routine
dans les services d'imagerie médicale –
Partie 3-1:
Essais d'acceptation –
Performance d'imagerie des appareils
à rayonnement X pour systèmes radiographiques
et radioscopiques
Reference number
Numbering
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The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
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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:
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Catalogue of IEC publications
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(On-line catalogue)*
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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
61223-3-1
First edition
1999-03
Evaluation and routine testing
in medical imaging departments –
Part 3-1:
Acceptance tests –
Imaging performance of X-ray equipment
for radiographic and radioscopic systems
Essais d'évaluation et de routine
dans les services d'imagerie médicale –
Partie 3-1:
Essais d'acceptation –
Performance d'imagerie des appareils
à rayonnement X pour systèmes radiographiques
et radioscopiques
 IEC 1999  Copyright - all rights reserved
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Commission Electrotechnique Internationale
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International Electrotechnical Commission
For price, see current catalogue

– 2 – 61223-3-1 © IEC:1999(E)
CONTENTS
Page
FOREWORD . 4

INTRODUCTION .5

Clause
1 Scope and object . 6

1.1 Scope.6
1.2 Object. 6
2 Normative references.7
3 Terminology.8
3.1 Degree of requirements. 8
3.2 Use of terms . 8
3.3 Defined terms.8
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 . 9
4.3 Test conditions.9
4.4 Test parameters.10
4.5 Test equipment including PHANTOMS (ATTENUATION devices) and TEST DEVICES. 11
4.6 Evaluating the test results . 12
5 Test methods for RADIOGRAPHY EQUIPMENT . 13
5.1 Visual and functional tests. 13
5.2 *X-RAY TUBE VOLTAGE. 13
5.3 *TOTAL FILTRATION . 14
5.4 *FOCAL SPOT of the X-RAY TUBE. 14
5.5 *Limitation and indication of the extent of the X-RAY BEAM. 15
5.6 *Linearity and reproducibility of TRANSMISSION KERMA or RADIATION OUTPUT. 17

5.7 *ATTENUATION RATIO of material between the PATIENT and the X-RAY
IMAGE RECEPTOR. 18
5.8 *AUTOMATIC EXPOSURE CONTROL (AEC). 18
5.9 LINE PAIR RESOLUTION for DIRECT RADIOGRAPHY. 20
5.10 * AIR KERMA area product indicator . 20
6 Test methods for RADIOSCOPY EQUIPMENT . 20
6.1 Visual and functional tests. 20
6.2 X-RAY TUBE VOLTAGE. 21
6.3 TOTAL FILTRATION . 21
6.4 FOCAL SPOT of the X-RAY TUBE . 21
6.5 Functioning of the AUTOMATIC EXPOSURE RATE CONTROL (AERC) . 21
6.6 Limitation of the extent of the X-RAY BEAM . 22

61223-3-1 © IEC:1999(E) – 3 –
Clause Page
6.7 ATTENUATION RATIO of material between the PATIENT and the X-RAY
IMAGE RECEPTOR. 23

6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER

for RADIOSCOPY . 23

6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with X-RAY IMAGE INTENSIFIER. 24

6.10 AIR KERMA at the ENTRANCE PLANE of the X-RAY IMAGE INTENSIFIER for
CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital

systems) . 25

6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems
(excluding digital systems) . 25
6.12 *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for
CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital
systems) . 26
6.13 *LOW CONTRAST RESOLUTION for RADIOSCOPY with X-RAY IMAGE INTENSIFIER and for
CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems (excluding digital
systems) . 27
6.14 AIR KERMA area product indicator. 28
7 Additional tests required for TOMOGRAPHY EQUIPMENT. 28
7.1 *Requirements . 28
7.2 Test method . 29
8 Test report and statement of compliance . 29
Annex A (normative) Terminology – Index of defined terms . 36
Annex B (informative) Test parameters, symbols and units . 39
Annex C (informative) Examples of low contrast TEST DEVICES. 40
Annex D (informative) Examples of requirements (accuracy, tolerances, discrepancies)
according to actual IEC standards or state of the art. 42
Annex E (informative) Bibliography . 46
Tables
B.1 Test parameters, symbols and units. 39
D.1 Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES . 42

D.2 Values for the discrepancy parameters X, Y and Z according to IEC 60601-1-3 . 43
D.3 Typical values for the TRANSMISSION KERMA index. 43
D.4 Typical values for the ATTENUATION RATIO of material between the PATIENT
and the X-RAY IMAGE RECEPTOR. 44
Figures
1 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT for AIR KERMA
measurements. 31
2 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT to test geometry
and resolutions. 32
3LINE PAIR RESOLUTION TEST DEVICE . 33
4TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE. 34
5 Discrepancies in visual indication of the X-RAY FIELD . 35
6 Discrepancies in covering the IMAGE RECEPTION AREA . 35

– 4 – 61223-3-1 © IEC:1999(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
EVALUATION AND ROUTINE TESTING

IN MEDICAL IMAGING DEPARTMENTS –

Part 3-1: Acceptance tests –
Imaging performance of X-ray equipment

for radiographic and radioscopic systems

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
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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 61223-3-1 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/361/FDIS 62B/365/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, C, D and E are for information only.
In this standard, the following print types are used:
– requirements, compliance with which can be tested,
...