SIST EN 61223-2-4:1998

SLOVENSKI STANDARD
01-september-1998
Evaluation and routine testing in medical imaging departments - Part 2-4:
Constancy tests - Hard copy cameras (IEC 61223-2-4:1994)
Evaluation and routine testing in medical imaging departments -- Part 2-4: Constancy
tests - Hard copy cameras
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung -- Teil
2-4: Konstanzprüfungen - Bilddokumentationssysteme
Essais d'évaluation et de routine dans les services d'imagerie médicale -- Partie 2-4:
Essais de constance - Reprographes
Ta slovenski standard je istoveten z: EN 61223-2-4:1994
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME CEI
IEC
INTERNATIONALE
1223-2-4
INTERNATIONAL
Première édition
STANDARD
First edition
1994-03
Essais d'évaluation et de routine
dans les services d'imagerie médicale -
Partie 2-4:
Essais de constance -
Reprographes
Evaluation and routine testing
in medical imaging departments -
Part 2-4:
Constancy tests -
Hard copy cameras
de reproduction réservés — Copyright — all rights reserved
© CEI 1994 Droits
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1223-2-4 © IEC:1994 — 3 —
CONTENTS
Page
FOREWORD 7
INTRODUCTION 11
Clause
1 Scope and object
1.1 Scope 13
1.2 Object
2 Normative references
3 Terminology
Degree of requirements 15
3.1
3.2 Use of terms 17
3.3 Definitions 17
CONSTANCY TESTS 4 General aspects of
General conditions affecting test procedures 4.1
BASELINE VALUES 4.2 Establishment of
CONSTANCY TESTS 4.3 Frequency Of
4.4 Identification of equipment, instrumentation and test conditions
4.5 Measured functional parameters
5 Test methods 21
5.1 Summary
5.2 Test equipment
5.3 Test procedure
5.4 Data evaluation 29
5.5 Criteria to be applied 31
5.6 Test report 31
31 5.7 Action to be taken
5.8 Frequency of testing
6 Statement of compliance
Figures
Schematic representation of a test pattern used to check the constancy with
35 respect to grey-scale reproduction

1223-2-4 © IEC:1994 -
5 -
Page
Figures
Schematic representation of a test pattern used to check the constancy with
respect to geometry and line structure
Schematic representation of a crosshatched pattern used to carry out
measurements with respect to geometry
Schematic representation of a test pattern used to check the constancy with
respect to resolution
Annexes
43 A Terminology - Index of terms
45 B Example of a form for the standardized test report
49 C Guidance on action to be taken
D Rationale
55 E Bibliography - Reference test pattern

1223-2-4 © IEC:1994 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS -
Part 2-4: Constancy tests -
Hard copy cameras
FOREWORD
The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
1)
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international cooperation 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.
The formal decisions or agreements of the IEC on technical matters, prepared by technical committees on
2)
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
They have the form of recommendations for international use published in the form of standards, technical
3)
reports or guides and they are accepted by the National Committees in that sense.
In order to promote international unification, IEC National Committees undertake to apply IEC International
4)
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.
International Standard IEC 1223-2-4 has been prepared by sub-committee 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:
DIS Report on voting
62B(CO)118
62B(CO)105
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.

1223-2-4 © IEC:1994 - 9 -
This standard forms part 2-4 of IEC 1223, 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
Constancy tests - Darkroom safelight conditions
Part 2-3:
Part 2-4: Constancy tests - Hard copy cameras
Constancy tests - Image display devices
Part 2-5:
Constancy tests - X-ray equipment for computed tomography
Part 2-6:
Constancy tests - X-ray equipment for classical dental radiography
Part 2-7:
Constancy tests - Protective shieldings, barriers and devices
Part 2-8:
Constancy tests - X-ray equipment for indirect radioscopy and indirect
Part 2-9:
radiography
Part 2-10: Constancy tests - X-ray equipment for mammography
Part 2-11: Constancy tests - X-ray equipment for general direct radiography
Part 2-12: Constancy tests - Film illuminators

1223-2-4 ©IEC:1994 - 11 -
INTRODUCTION
Some provisions or statements in the body of this part of IEC 1223 require additional
information. Such information is presented in annex D, Rationale. An asterisk in the left
margin of a clause or subclause indicates the presence of such additional information.

1223-2-4 © IEC:1994 - 13 -
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS -
Part 2-4: Constancy tests -
Hard copy cameras
1 Scope and object
1.1 Scope
HARD COPY CAMERAS producing images on monochrome
This part of IEC 1223 applies to
continuous tone material (such as photographic films and materials sensitive to infrared
radiation), and comprising types of cameras using a cathode ray tube, laser beam, or a
thermoprinting system, as used in diagnostic imaging systems such as:
digital radiography;
- digital subtraction angiography;
- imaging in COMPUTED TOMOGRAPHY;
magnetic resonance imaging;
ultrasound imaging;
- imaging in NUCLEAR MEDICINE.
* The test methods are based on the use of test patterns.
NUCLEAR
This standard does not apply to x-y (analogue) recording systems used in
MEDICINE.
This standard is a part of a series of Particular Publications (standards and technical
s) which give methods of tests for the constancy of properties of diagnostic imaging
repo rt
systems as described in IEC 1223-1 (see clause 2).
*1.2
Object
of IEC 1223 describes a method to check, in terms of functional parameters, the
This part
in order to ensure that
HARD COPY CAMERAS
constancy of the quality of images produced by
the required conditions for producing consistent hard copies are maintained after the
calibration and adjustment have been carried out.
The aims of the method are:
HARD COPY CAMERA when such
to establish a reference level of performance for the
-
equipment has been accepted;
- to detect and verify any significant variation in functional parameters which may
then require corrective actions.
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 method described in this standard (see clause 2).

1223-2-4 © IEC:1994 -15 -
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 indicated below. Members
of IEC and ISO maintain registers of currently valid International Standards.
IEC 788: 1984, Medical radiology - Terminology
rt 1:
Evaluation and routine testing in medical imaging departments - Pa
IEC 1223-1: 1993,
General aspects
Evaluation and routine testing in medical imaging departments -
IEC 1223-2-1: 1993,
Part 2-1: Constancy tests - Film processors
Evaluation and routine testing in medical imaging departments -
IEC 1223-2-2: 1993,
Part 2-2: Constancy tests - Radiographic cassettes and film changers - Film-screen
contact and relative sensitivity of the screen-cassette assembly
Evaluation and routine testing in medical imaging departments -
IEC 1223-2-3: 1993,
Part 2-3: Constancy tests - Darkroom safelight conditions
Evaluation and routine testing in medical imaging departments -
IEC 1223-2-5: 1994,
Part 2-5: Constancy tests - Image display devices
Evaluation and routine testing in medical imaging departments -
IEC 1223-2-12: 19XX,
(under consideration)
Part 2-12: Constancy tests - Film illuminators
3 Terminology
Degree of requirements
3.1
In this part of IEC 1223 the verbal form:
implies that compliance with a requirement is mandatory for
"shall"
compliance with the standard;
implies that compliance with a requirement is strongly recommended
"should"
but is not mandatory for compliance with the standard;
implies that compliance with a requirement is permitted to be
"may"
accomplished in a particular manner, for compliance with the standard.
The term:
when used with parameters or conditions: refers to a particular value
"specific"
or standardized arrangement, usually to those required in an IEC
publication or a legal requirement;
when used with parameters or conditions: refers to a value or
"specified"
arrangement to be chosen for the purpose under consideration and
ACCOMPANYING DOCUMENTS.
indicated usually in
1223-2-4 © IEC:1994 –17 –
3.2 Use of terms
SMALL CAPITALS are used as defined in IEC 788,
In this part of IEC 1223, terms printed in
3.3 of this standard or other IEC Publications referenced in annex A. Where a defined
term is used as a qualifier in another defined or undefined term it is not printed in capital
letters, unless the concept thus qualified is defined, or recognized as a derived term
without definition.
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.
Definitions
3.3
Device producing non-erasable images on a sheet of material
3.3.1 HARD COPY CAMERA:
from an input signal provided by an imaging system.
NOTE — Definition from IEC 1223-2-5: IMAGE DISPLAY DEVICE: Device capable of displaying images from
an input signal provided by an imaging system.
4 General aspects of CONSTANCY TESTS
For diagnostic imaging systems every link in the imaging chain may limit or degrade the
HARD COPY CAMERAS and IMAGE
image quality of the system. This holds especially for
DISPLAY DEVICES.
are properly adjusted and maintained
IMAGE DISPLAY DEVICE
* If HARD COPY CAMERAS and
(see clause 2) both equipment should consistently produce images that appear similar.
The methods for testing the constancy described in this standard are intended to enable
to detect changes in image quality of images produced by HARD COPY
the OPERATOR
CAMERAS.
described in this standard to be valid, it is
For the results of the CONSTANCY TESTS
essential to ensure that they are not significantly influenced by anything other than
changes in the parameters under test.
Attention shall be paid to darkroom safelight conditions and proper film processing
(see IEC 1223-2-3, reference in clause 2). Special attention should also be paid to lighting
FILM ILLUMINATORS (see IEC 1223-2-12, reference in clause 2).
conditions, when using
Careful consideration shall be given to the operating and test conditions under which the
equipment is checked, including environmental influences.
All equipment under test or used for testing shall be marked in order to permit easy
CONSTANCY TEST and to assist in
identification as those items are used in the initial
CONSTANCY TESTS. Prior to
ensuring that the same items are used subsequently in related
CONSTANCY TESTS shall be checked.
testing, the constancy of all equipment that is used for

1223-2-4 © IEC:1994 - 19 -
4.1 General conditions affecting test procedures
described in this standard have been designed to be robust, that is,
The CONSTANCY TESTS
their results should be affected only by changes in the parameters under investigation.
The range of test pattern and test equipment has been kept to a minimum and restricted
where possible to devices that are passive, inherently simple or reasonably stable.
However, it is important:
to consider the influence of environmental changes, particularly variations in supply
-
voltage, on the results;
- to use photographic film which is handled, processed and viewed in accordance
with the standards or technical reports referenced in clause 2.
4.2 Establishment of BASELINE VALUES
When new diagnostic imaging equipment is brought into use, or any component of the
ACCESSORIES or test equipment is changed which may
diagnostic imaging equipment,
CONSTANCY TEST shall be carried out
cause a variation in the test result, an initial
or STATUS TEST has indicated that the standard of
immediately after an ACCEPTANCE TEST
performance is satisfactory. The purpose of the initial CONSTANCY TEST is to establish new
BASELINE VALUE(S) for the parameter(s) tested.
4.3 Frequency of CONSTANCY TESTS
should be repeated as indicated for the individual test procedures.
The CONSTANCY TESTS
CONSTANCY TESTS should be repeated:
In addition, the
- whenever malfunction is suspected;
- immediately after the equipment has undergone maintenance that could affect the
performance parameter(s) under test; and
leads to results outside the established criteria, to
- whenever the CONSTANCY TEST
confirm the test result.
4.4 Identification of equipment, instrumentation and test conditions
All equipment under test or used for testing shall be unequivocally identified.
4.5 Measured functional parameters
In order to detect significant changes in equipment performance, the following
performance aspects are measured:
- grey-scale reproduction;
- geometry of the image;
- spatial resolution and low-contrast resolution.
Careful consideration shall be given to the appropriate choice of standard test conditions
under which the equipment is checked, including environmental parameters.

— 21 —
1223-2-4 © IEC:1994
All related tests made in accordance with this standard shall be made:
ACCESSORIES and test instrumentation
using the identical equipment components,
—
as during the initial CONSTANCY TEST;
with geometrical arrangements and environmental conditions kept as constant as
—
possible.
results and BASELINE VALUES is
When a significant deviation between CONSTANCY TEST
observed, not only the test instrumentation shall be re-checked, but also the positioning of
the instrumentation, including the test pattern and the measurements repeated. If a
significant deviation is still observed appropriate action shall be taken (see annex C).
When a component, which may cause a significant variation in the test result is changed,
shall be
BASELINE VALUES
either in the equipment or the test instrumentation, new
determined.
HARD COPY CAMERAS remain in use.
Records of all test results shall be kept as long as the
5 Test methods
5.1 Summary
HARD
Test images are used to check the constancy of the quality of images produced by a
The test images allow testing of grey-scale reproduction, spatial resolution,
COPY CAMERA.
low-contrast resolution, geometry of the image, and line structure.
5.2 Test equipment
5.2.1 Test film
HARD COPY CAMERAS shall be carried out with the same
Tests for checking constancy of
type of film that is used for regular clinical use.
should be of the same sensitivity, as indicated by the
NOTE - Preferably, films used for CONSTANCY TESTS
emulsion number, as used for regular clinical use.
5.2.2 Densitometer
Optical densities shall be measured with a densitometer which reads consistently with an
accuracy of ± 0,02.
5.2.3 Test images
A test image (or set of test images) of a digitally or electronically generated technical test
pattern should consist of a technical test pattern and a clinical test image typical for the
application involved. This clinical test image is called the clinical reference image.
Each test image is provided with predefined display parameters.
HARD
The technical test pattern provides a standard signal to test the constancy of the
COPY CAMERA.
1223-2-4 © IEC:1994 - 23 -
The size of the test pattern, in pixels, shall be identical to the size of a typical clinical image.
The test images shall allow testing of the following functional parameters:
a) grey-scale reproduction (figure 1);
spatial resolution and low-contrast resolution (figure 4);
b)
c) geometry (figures 2 and 3);
d) line structure (figure 2).
to form a more compact test
NOTE — The test images according to figures 1 and 2 may be combined
image.
For checking the quality of clinical images the clinical reference image shall be used.
For these functional parameters the following test patterns are required.
Grey-scale reproduction test pattern
a)
A grey scale with 16 to 32 equally spaced levels of intensity on the digital scale of the
image input source using the full dynamic range shall provide a series of optical densi-
FILM BASE PLUS FOG DENSITY) (see
ties including the range between 0,25 and 1,6 (above
figure 1).
However, a reduced number of 11 equally spaced grey levels can be used, provided
two extra levels are added corresponding to a half-step from the first and last level.
Each segment of the grey scale shall have a height not smaller than 1/16 of the image
height.
SMPTE pattern (see annex E).
NOTE — All basic features are realized in the
Two additional squares representing maximum and minimum values shall also be
present. The size of each square shall be 1/8 to 1/4 of the height of the image (see
figure 1).
Spatial resolution and low-contrast resolution test pattern
b)
ical and horizontal high-contrast bar patterns shall be placed in five locations (four
Ve rt
corners and the centre; see figure 4). The modulation of the pattern shall be 100 %.
Low-contrast bar patterns with a modulation of 25 % and 6,25 %, symmetrically placed
around 50 % maximum value, measured in the digital scale of the image input source,
should also be available in the centre of the test pattern.
All
...