IEC 61223-3-2:2007

INTERNATIONAL IEC
STANDARD
CEI
61223-3-2
NORME
Second edition
INTERNATIONALE
Deuxième édition
2007-07
Evaluation and routine testing
in medical imaging departments –
Part 3-2:
Acceptance tests –
Imaging performance of
mammographic X-ray equipment
Essais d’évaluation et de routine
dans les services d’imagerie médicale –
Partie 3-2:
Essais d’acceptation –
Performance d’imagerie des appareils
de mammographie à rayonnement X
Reference number
Numéro de référence
IEC/CEI 61223-3-2:2007
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INTERNATIONAL IEC
STANDARD
CEI
61223-3-2
NORME
Second edition
INTERNATIONALE
Deuxième édition
2007-07
Evaluation and routine testing
in medical imaging departments –
Part 3-2:
Acceptance tests –
Imaging performance of
mammographic X-ray equipment
Essais d’évaluation et de routine
dans les services d’imagerie médicale –
Partie 3-2:
Essais d’acceptation –
Performance d’imagerie des appareils
de mammographie à rayonnement X
PRICE CODE
XB
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 2 – 61223-3-2 © IEC:2007
CONTENTS
FOREWORD.4
INTRODUCTION.6

1 Scope.7
2 Normative references .8
3 Terms and definitions .9
4 General aspects of the ACCEPTANCE TEST.12
4.1 Levels of compliance.12
4.2 General conditions in test procedures .12
4.3 Documents and data for the tests .13
4.4 Test conditions.14
4.5 Scope of tests .14
4.6 Test EQUIPMENT .15
4.7 Evaluating the test results .16
5 Test methods for mammographic X-RAY EQUIPMENT .17
5.1 Initial test and inventory .17
5.2 X-RAY TUBE VOLTAGE .17
5.3 HALF VALUE LAYER (HVL) .18
5.4 NOMINAL FOCAL SPOT VALUE .19
5.5 X-RAY FIELD limitation and beam alignment .19
5.6 Radiation output .20
5.7 AUTOMATIC EXPOSURE CONTROL (AEC) .20
5.8 Reproducibility of the AIR KERMA .26
5.9 ATTENUATION RATIO of material between the upper surface of the PATIENT
SUPPORT and the IMAGE RECEPTION PLANE.26
5.10 Breast COMPRESSION DEVICE .27
5.11 Uniformity.28
5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image
receptors, including storage phosphor systems .30
5.13 Spatial resolution .31
5.14 LOW CONTRAST DETECTABILITY .34
5.15 Entrance surface AIR KERMA.35
5.16 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES .36
6 Baseline values for CONSTANCY TESTS .37
7 Test report and statement of compliance .37

Annex A (informative) TEST DEVICES and arrangements for testing the automatic
exposure control system with a digital X-RAY IMAGE RECEPTOR.39
Annex B (informative) TEST DEVICE for testing the dynamic range of systems with a
digital X-RAY IMAGE RECEPTOR.43
Annex C (informative) Test methods for screen-film X-ray image receptor .44
Annex D (informative) Test methods for storage phosphor system .46

61223-3-2 © IEC:2007 – 3 –
Annex E (informative) Example of a method for the determination of the AVERAGE
GLANDULAR DOSE .49
Annex F (informative) Example of TEST DEVICES and arrangements for testing the
system contrast transfer function for systems with a digital X-RAY IMAGE RECEPTOR.51
Annex G (informative) LOW CONTRAST DETECTABILITY test for mammographic X-RAY
EQUIPMENT using an integrated digital X-RAY IMAGE RECEPTOR or storage phosphor
plates .52
Annex H (informative) Example of a mammographic stereotactic TEST DEVICE .54
Annex I (normative) Set-up for HALF-VALUE LAYER measurements .55
Annex J (informative) Definition of the ROIs for testing lag effects .56
Annex K (informative) ARTIFACTS and other non-uniformities.57
Annex L (informative) Cross reference and history.59

Bibliography.60

Terminology – Index of defined terms .62

Figure A.1 – Basic ATTENUATION Plates.39
Figure A.2 – Alternative design for the top attenuating plate .40
Figure A.3 – Alternative design for the two additional attenuating plates (two pieces
required).41
Figure A.4 – Measurement of CNR: 2-step methods.42
Figure B.1 – Test object for the dynamic range (to be used together with a 20 mm
PMMA plate placed on top) .43
Figure F.1 – Example of 45° test pattern for the evaluation of the system contrast
transfer function.51
Figure H.1 – Example of a mammographic stereotactic TEST DEVICE.54
Figure I.1 – Set-up for HALF-VALUE LAYER measurements.55
Figure J.1 – Definition of the ROIs for testing lag effects.56

Table 1 – Symbols, physical quantities, abbreviations and units used in this standard .11
Table 2 – Examples of typical HALF-VALUE LAYERS (HVL) in millimetres of aluminium
(mm Al) for mammographic X-RAY EQUIPMENT with different TARGET FILTER combinations
operated at different X-RAY TUBE VOLTAGES .18
Table E.1 – g for breasts simulated with PMMA .50
Table E.2 – c for breasts simulated with PMMA .50
Table E.3 – Typical HVL measurements for different tube voltage and TARGET FILTER
combinations .50
Table E.4 – s for clinically used spectra [Dance et al. 2000].50
Table L.1 – Cross reference list for Editions 1 and 2 of this standard .59

– 4 – 61223-3-2 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-2: Acceptance tests –
Imaging performance of mammographic X-ray equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
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Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
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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 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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
EQUIPMENT declared to be in conformity with an IEC Publication.
6) All USERS should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61223-3-2 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition, published in 1996. It constitutes a
technical revision. This second edition has been expanded by including tests of equipment
properties depending on X-RAY IMAGE RECEPTORS, by putting emphasis on the aspect of image
quality and dose and through harmonization, where possible, with other recognized
standards. Annex L compares the specific content of the first and second editions.

61223-3-2 © IEC:2007 – 5 –
The text of this standard is based on the following documents:
FDIS RVD
62B/651/FDIS 62B/659/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 2.
A list of all parts of the IEC 61223 series, published under the general title Evaluation and
routine testing in medical imaging departments, can be found on the IEC website.
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;
– TERMS DEFINED IN IEC 60788, IEC 60601-1 OR IN CLAUSE 3 OF THIS STANDARD: SMALL
CAPITALS (see Index of defined terms).
NOTE 1 Where a defined term is used as a qualifier with another defined or undefined term, it is not printed in
SMALL CAPITALS, unless the concept thus qualified is defined, or recognized as a derived term without a definition.
NOTE 2 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.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
– 6 – 61223-3-2 © IEC:2007
INTRODUCTION
This standard is part of a series of International Standards which give methods of acceptance
testing and constancy testing for diagnostic X-RAY EQUIPMENT.
This second edition of the particular standard for the ACCEPTANCE TEST of mammographic X-
RAY EQUIPMENT describes test methods for EQUIPMENT using RADIOGRAPHIC FILMS, EQUIPMENT
using storage phosphor plates, EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS,
and MAMMOGRAPHIC STEREOTACTIC DEVICES.

61223-3-2 © IEC:2007 – 7 –
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-2: Acceptance tests –
Imaging performance of mammographic X-ray equipment

1 Scope
This part of IEC 61223 applies to the effectiveness of mammographic X-RAY EQUIPMENT, with
respect to image quality and dose, in combination with aspects of EQUIPMENT safety.
This standard applies to mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC
DEVICES.
The tests described in this standard require the quality and performance of the X-RAY IMAGE
RECEPTORS to be assured prior to the acceptance testing when they are not an integral part of
the mammographic X-RAY EQUIPMENT. This includes RADIOGRAPHIC FILMS, INTENSIFYING
SCREENS, RADIOGRAPHIC CASSETTES, storage phosphor plates and ASSOCIATED EQUIPMENT such
as film processors or storage phosphor plate readers, IMAGE DISPLAY DEVICES and HARD COPY
CAMERAS.
For testing RADIOGRAPHIC CASSETTES and INTENSIFYING SCREENS, this standard makes
reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are
considered to be stated according to ISO 9236-3.
NOTE Currently there exists no IEC standard for acceptance testing of HARD COPY CAMERAS or IMAGE DISPLAY
DEVICES.
By the measurements described in this standard, data for AVERAGE GLANDULAR DOSE
calculation can be determined.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the
baseline values for the subsequent CONSTANCY TESTS are established.
This part of IEC 61223 defines
a) the essential parameters which describe the performance of the above-mentioned
mammographic X-RAY EQUIPMENT with regard to image quality and dose; and
b) the methods of testing whether measured quantities related to those parameters comply
with specified tolerances.
These methods mainly rely on non-invasive measurements that use appropriate test
EQUIPMENT and are performed during or after the installation. Signed statements covering
steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests
required by a higher level of compliance take precedence over similar tests with a lower level
of compliance. This concept is described in 4.1.

– 8 – 61223-3-2 © IEC:2007
This standard does not in itself specify limiting values or tolerances for the parameters under
investigation.
A difficulty may arise with regard to the responsibility for acceptance testing when the
film/screen combination, film processing chemistry or computed radiography system is
changed. This arises from a combination of causes. Firstly, the image receptor MANUFACTURER
and the X-RAY EQUIPMENT MANUFACTURER may be different. Secondly a change in image
receptor or film processing chemistry may alter the system performance. When system
integration such as the above occurs, it is important that acceptance testing is performed.
When a change occurs which could alter system performance, it is essential that the system
integrator (i.e. whoever is responsible for this change) discusses the implication of their
change with the X-RAY EQUIPMENT MANUFACTURER so that the latter can adjust the imaging
system if necessary.
ACCEPTANCE TESTING of mammographic X-RAY EQUIPMENT requires average skill in medical
physics. However, the decision concerning who performs the test is determined by local rules
(e.g. contract, regulation, law).
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 60336:2005, Medical electrical equipment – X-ray tube assemblies for medical diagnosis
– Characteristics of focal spots
IEC 60601 (all parts), Medical electrical equipment
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-2-45, Medical electrical equipment – Part 2-45: Particular requirements for the
safety of mammographic X-ray equipment and mammographic stereotactic devices
IEC 61223-2-1, Evaluation and routine testing in medical imaging departments –
Part 2-1: Constancy tests – Film processors
IEC 61674, Medical electrical equipment – Dosimeters with ionization chambers and/or semi-
conductor detectors as used in X-ray diagnostic imaging
IEC 61676:2002, Medical electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
ISO 4090, Photography – Medical radiographic cassettes/screens/films and hard-copy
imaging films – Dimensions and specifications
ISO 9236-3, Photography – Sensitometry of screen/film systems for medical radiography –
Part 3: Determination of sensitometric curve shape, speed and average gradient for
mammography
61223-3-2 © IEC:2007 – 9 –
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Symbols, physical quantities, abbreviations and units used in this standard are given at the end of this
clause in Table 1.
3.1
ACCEPTANCE TEST
test carried out after new EQUIPMENT has been installed, or major modifications have been
made to existing EQUIPMENT, in order to verify compliance with MANUFACTURER’s specifications
or requirements
[IEC 61223-1, definition 3.2.4, modified]
3.2
ARTIFACT
apparent structure, visible in the image, which does not represent a structure within the object
[IEC 61223-3-4, definition 3.3.1]
3.3
CONSTANCY TEST
each of a series of tests, carried out:
– to ensure that the functional performance of the EQUIPMENT meets ESTABLISHED CRITERIA;
or
– to enable the early recognition of changes in the properties of components of the
EQUIPMENT
[IEC 61223-1, definition 3.2.6]
3.4
DIRECT FOCAL DISTANCE
shortest distance from the FOCAL SPOT to the axis of symmetry of the effective IMAGE
RECEPTION AREA perpendicular to the chest wall edge of the X-RAY IMAGE RECEPTOR
[IEC 60601-2-45, definition, 2.101.4, modified]
3.5
(DIAGNOSTIC) DOSIMETER
EQUIPMENT which uses IONIZATION CHAMBERS and/or semi-conductor detectors for the
measurement of AIR KERMA, air kerma length and/or AIR KERMA RATE in the beam of an X-ray
machine used for diagnostic medical radiological examinations
A DIAGNOSTIC DOSIMETER contains the following components:
– one or more detector assemblies which may or may not be an integral part of the
measuring assembly;
– a measuring assembly; and/or
– one or more stability check devices (optional)
[IEC 61674, definition 3.1]
3.6
LOW CONTRAST DETECTABILITY
capability of an imaging system to differentiate a low contrast object from a uniform
background
– 10 – 61223-3-2 © IEC:2007
3.7
AVERAGE GLANDULAR DOSE
AGD
X-ray mammography average absorbed dose in the glandular tissue (excluding skin) in a
uniformly compressed breast of known tissue composition, using a specified calculation
method
3.8
CONTRAST TO NOISE RATIO
CNR
physical quantity describing the ability to distinguish between various contrast objects of a
digital image and the inherent noise within the image, defined as the difference of mean pixel
values of the contrast objects and image background, and divided by the standard deviation
of the image background pixel value
3.9
ORIGINAL DATA
RAW DATA to which the corrections described below have been applied
The following linear and image-independent corrections of the RAW DATA are allowed in
advance of the processing of the data for the determination of the CONVERSION FUNCTION, the
NOISE POWER SPECTRUM, and the MODULATION TRANSFER FUNCTION. All the following corrections
if used shall be made as in normal clinical use:
– replacement of the RAW DATA of bad or defective pixels by appropriate data;
– a flat-field correction comprising
• correction of the non-uniformity of the RADIATION FIELD;
• correction for the offset of the individual pixels, and
• gain correction for the individual pixels;
– a correction for geometrical distortion;
– a correction for time variation during a scan.
NOTE Some detectors execute linear image processing due to their physical concept. As long as this image
processing is linear and image-independent, these operations are allowed as an exception.
3.10
RAW DATA
pixel values read directly after the analogue-digital-conversion from the digital X-ray imaging
device or counts from photon counting systems without any software corrections
3.11
SIGNAL TO NOISE RATIO
SNR
measure of signal strength versus the background noise, defined as the ratio of mean pixel
values of an area of interest in an image to the standard deviation of the pixel value of the
area of interest
3.12
AUTOMATIC EXPOSURE CONTROL
AEC
in a radiological EQUIPMENT, mode of operation in which, in reaction to the properties of the
object, one or more of the LOADING FACTORS or IRRADIATION conditions are controlled
automatically in order to obtain at a pre-selected location a desired quantity of radiation of a
desired quality
61223-3-2 © IEC:2007 – 11 –
NOTE Examples of such properties of the object are: thickness, composition, or x-ray transmission. Examples for
IRRADIATION conditions are the focal track of the X-RAY TUBE and ADDED FILTERS.
3.13
OVERALL UNCERTAINTY
uncertainty associated with the MEASURED VALUE, i.e. representing the bounds within which the
ERROR OF MEASUREMENT is estimated to lie
[IEC 61674, definition 3.5.2]
3.14
LINEARIZED DATA
ORIGINAL DATA to which the inverse CONVERSION FUNCTION has been applied.
NOTE The LINEARIZED DATA are directly proportional to the exposure.
3.15
CONVERSION FUNCTION
plot of the large area output level (ORIGINAL DATA) of a DIGITAL X-RAY IMAGING DEVICE versus the
number of exposure quanta per unit area (Q) in the DETECTOR SURFACE plane.
Table 1 – Symbols, physical quantities, abbreviations and units used in this standard
Symbol Physical quantity Unit
D Visual optical density (usually called optical density) -
D Net density (optical density of a film minus its minimum density) -
n
D Minimum density (sum of fog and optical density of film base) -

min
Average gradient of a screen-film system in a given range of optical density -
G
K AIR KERMA Gy
K Entrance surface AIR KERMA mGy
E
K AIR KERMA in the IMAGE RECEPTION PLANE µGy
B
K Nominal AIR KERMA to generate a net density D = 1,0 µGy
N n
(following the procedure of this standard)
Q CURRENT TIME PRODUCT mAs
AEC AUTOMATIC EXPOSURE CONTROL -
AGD AVERAGE GLANDULAR DOSE mGy
CNR CONTRAST TO NOISE RATIO -
HVL HALF VALUE LAYER mmAl
MTF MODULATION TRANSFER FUNCTION -
PMMA Polymethylmethacrylate -
ROI Region of interest -
SNR SIGNAL TO NOISE RATIO -
NOTE The nominal AIR KERMA K is not the same as the AIR KERMA K stated by the MANUFACTURER, but gives an
N s
estimate. The AIR KERMA K for a mammographic screen-film system is the AIR KERMA generating a net density
s
D = 1,0 according to ISO 9236-3 (laboratory measurement).
n
– 12 – 61223-3-2 © IEC:2007
4 General aspects of the ACCEPTANCE TEST
4.1 Levels of compliance
Tests required by a higher level of compliance take precedence over similar tests with a lower
level of compliance.
4.1.1 Local regulatory
Local regulatory requirements, including test procedures and acceptable values, shall take
precedence over similar contractual requirements or corresponding items in this document.
4.1.2 Contractual
Individual contractual requirements, including test procedures and acceptable values, shall
take precedence over similar corresponding items in this document.
NOTE Requirements for status tests should be included in the contractual requirements.
4.1.3 General
In the absence of specific regulatory or contractual requirements, the test procedures in this
document shall be applicable.
Values and acceptable tolerances shall be in accordance with the MANUFACTURER’s
specifications for the EQUIPMENT.
4.2 General conditions in test procedures
The aim of the ACCEPTANCE TEST is to demonstrate that the specified characteristics of the
EQUIPMENT lie within specified tolerances. These tolerances are determined by regulatory or
contractual requirements. Prior to the ACCEPTANCE TEST procedures, an inventory of the
EQUIPMENT shall be established.
The X-RAY EQUIPMENT and its components shall be unambiguously identified, for example with
respect to type and SERIAL NUMBER, and checked against the order contract. The check shall
also encompass ascertaining that the ACCOMPANYING DOCUMENTS, records and acceptance
criteria according to this standard are complete, that delivery is complete, and that the
documents relate to the EQUIPMENT delivered.
Prior to the ACCEPTANCE TEST, the X-RAY EQUIPMENT shall be calibrated for the specific needs
of the image receptor in use. In case of a non-integrated image receptor, the system
integrator shall provide the specifications and the conditions of use for the resulting system.
NOTE It is important to recognize that the energy response of image receptors can differ significantly as they
differ in design, materials and technology. Adjusting the AUTOMATIC EXPOSURE CONTROL means that exposure
parameters are tuned to reach a specified response values for the image receptor for a variety of ATTENUATION
combinations.
For mammographic X-RAY EQUIPMENT using RADIOGRAPHIC FILMS, the film processing shall be
tested prior to the ACCEPTANCE TESTing of the mammographic X-RAY EQUIPMENT. It has to be
assured that the RADIOGRAPHIC CASSETTES with INTENSIFYING SCREENS, the RADIOGRAPHIC FILMS
and the film processing perform in the specified way, for example with respect to sensitivity,
reproducibility, contrast and absence of ARTIFACTS. A test of the performance of these
components shall precede any ACCEPTANCE TEST measurements involving RADIOGRAPHIC
FILMS, for example by applying the methods described in ISO 4090, in Annex C of this
CONSTANCY TESTS according to IEC 61223-2-1.
standard, and the
61223-3-2 © IEC:2007 – 13 –
When digital images are quantitatively assessed, LINEARIZED DATA shall be used, and
acquired with a RADIATION BEAM quality specified by the MANUFACTURER.
No post-processing shall be applied on the ORIGINAL DATA used for purposes of quantitative
image analysis.
For mammographic X-RAY EQUIPMENT using a storage phosphor system, the storage phosphor
system shall be tested prior to the acceptance testing of the mammographic X-RAY EQUIPMENT
to assure that the storage phosphor system performs as designed. Examples of the test
methods for storage phosphor tests are described in Annex D.
The IMAGE DISPLAY DEVICES involved in the ACCEPTANCE TEST shall be tested prior to the
ACCEPTANCE TEST of the mammographic X-RAY EQUIPMENT. It has to be assured that the IMAGE
DISPLAY DEVICES perform in the specified way, for example with respect to contrast and
absence of ARTIFACTS.
The HARD COPY CAMERAS involved in the ACCEPTANCE TEST shall be tested prior to the
ACCEPTANCE TEST of the mammographic X-RAY EQUIPMENT as recommended by the camera
MANUFACTURER. It has to be assured that the HARD COPY CAMERAS perform in the specified
way, for example with respect to contrast and absence of ARTIFACTS detrimental to patient
diagnoses.
Non-invasive measurements are preferred for the ACCEPTANCE TEST. Whenever invasive tests
are part of the programme, it shall be shown that the EQUIPMENT has been restored to its
original condition.
NOTE 1 In general, for mammography X-RAY EQUIPMENT with a non-integrated X-RAY IMAGE RECEPTOR, the X-RAY
EQUIPMENT may be tested before testing the system with the image receptor for those functions of the X-RAY
EQUIPMENT which does not involve the performance of the image receptor.
NOTE 2 The test procedures and methods are established to demonstrate proper system setup and function and
not to reflect performance under optimized clinical operation. As such, these specifications should not be used to
compare expected clinical performance between systems. Other measures are needed for such comparisons.
4.3 Documents and data for the tests
Together with the mammographic X-RAY EQUIPMENT, the following documentation is required:
– statements of compliance with applicable parts of IEC 60601;
EQUIPMENT/parts of EQUIPMENT ordered and actual delivery list (IEC 60601-1);
– list of
– list of applicable tests and acceptance criteria according to this standard as agreed upon
between the USER and the supplier of the EQUIPMENT;
– results from tests performed earlier by the MANUFACTURER on the EQUIPMENT delivered as
contracted;
– INSTRUCTIONS FOR USE
– reports on previous quality assurance tests where applicable; and
– documentation of technical changes performed on the EQUIPMENT.
The following documentation shall be present if applicable:
– test report on the film processing;
RADIOGRAPHIC CASSETTE testing;
– report on
– test report on the viewing boxes;

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– test report on HARD COPY CAMERAS and IMAGE DISPLAY DEVICES; and
– test report on storage phosphor system.
4.4 Test conditions
Different categories of tests can be identified:
– visual inspection;
– functional tests; and
– system performance.
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 mammographic X-RAY EQUIPMENT tested,
identification of the test EQUIPMENT used, geometrical set-up, operating characteristics,
correction factors and test results of the ASSOCIATED EQUIPMENT (film, screen, processing)
shall be recorded with the test results. The record shall include the location, the date and the
names of the persons performing the tests.
If not specified otherwise, in all tests where a TEST DEVICE is required, it shall be placed
directly on the PATIENT SUPPORT. The TEST DEVICE shall be centred laterally on the PATIENT
SUPPORT, and the chest wall edges of the TEST DEVICE and the PATIENT SUPPORT shall be in
line.
4.5 Scope of tests
The following items are subject to acceptance testing within this standard:
– initial tests and inventory (5.1);
– X-RAY TUBE VOLTAGE (5.2);
– HALF VALUE LAYER (5.3);
– NOMINAL FOCAL SPOT VALUE (5.4);
– X-RAY FIELD limitation and beam alignment (5.5);
– radiation output (5.6);
– AUTOMATIC EXPOSURE CONTROL (AEC) (5.7);
– reproducibility of the AIR KERMA (5.8);
– ATTENUATION RATIO of material between the upper surface of the PATIENT SUPPORT and the
IMAGE RECEPTION PLANE (5.9);
– breast COMPRESSION DEVICE (5.10);
– Uniformity (5.11);
– Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image receptors,
including storage phosphor systems (5.12);
– spatial resolution (5.13);
– LOW CONTRAST DETECTABILITY (5.14);
– entrance surface AIR KERMA (5.15); and
– Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES (5.16).

61223-3-2 © IEC:2007 – 15 –
4.6 Test EQUIPMENT
4.6.1 General
The measurement EQUIPMENT used for the ACCEPTANCE TEST shall be certified as calibrated
against a national or international standard where such a standard exists. Details on the test
EQUIPMENT are specified in 4.6.2 to 4.6.8.
Test EQUIPMENT required but not specified in 4.6.2 to 4.6.8:
– thermometer (as required for film processor);
– block of foam rubber as specified in 5.10.3.1;
– magnifying glass (magnifying at least × 4);
– TEST DEVICES;
– test cassette and radio-opaque markers as specified in 5.5.2;
– 20 mm PMMA as specified in 5.11.3.1;
– Wire grid as specified in 5.11.3.3;
– lag effects TEST DEVICE as specified in 5.11.3.4.1;
– spatial resolution bar pattern as specified in 5.13.1.2;
– TEST DEVICE with low contrast structures as specified in 5.14;
– step wedge in PMMA as described as an example in Annex B;
– stereotactic TEST DEVICE as described as an example in Annex H;
– measurement EQUIPMENT used for determining the baseline values for CONSTANCY TESTS
according to Cause 6.
4.6.2 High-voltage measuring instrument
The high-voltage measuring instrument shall determine the X-RAY TUBE VOLTAGE within the
specified range. Instruments based on either direct or indirect measurements following
IEC 61676 (2002) may be used. The OVERALL UNCERTAINTY shall be less than ±2 % or ±0,7 kV,
whichever is the larger.
NOTE Special features of mammographic X-RAY EQUIPMENT such as molybdenum TARGETS and possible K-edge
FILTERS will be taken into account when calibrating the devices used for indirect measurements. The quoted
uncertainty with non-invasive test methods can often only be achieved with special calibration for the type of X-RAY
EQUIPMENT under test.
4.6.3 CURRENT TIME PRODUCT measuring instrument
The range of this device shall cover the range of the CURRENT TIME PRODUCT selectable with
the X-RAY EQUIPMENT, typically 0 mAs to 800 mAs. The OVERALL UNCERTAINTY shall not exceed
±5 % or ±0,5 mAs, whichever is the larger. If the built-in CURRENT TIME PRODUCT measuring
instrument is to be used in the ACCEPTANCE TEST, it shall be proven by calibration to comply
with these specifications.
4.6.4 LOADING TIME measuring instrument
The LOADING TIME measuring instrument shall enable the LOADING TIME to be determined
according to IEC 60601-2-45. The shortest and longest specified LOADING TIMES shall be
OVERALL UNCERTAINTY shall not exceed ±2 % or ±1 ms, whichever is the
measurable. The
larger. If the built-in LOADING TIME measuring instrument is to be used in the ACCEPTANCE TEST,
it shall be proved by calibration to comply with these specifications.

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4.6.5 DOSIMETER
The range of the integrating DOSIMETER for the measurement of the AIR KERMA shall be at least
10 µGy to 500 µGy for the measurements behind a PHANTOM, and at least 0,1 mGy to
100 mGy for direct output measurements, with an OVERALL UNCERTAINTY less than ±10 %. This
includes recombination losses at the AIR KERMA RATES involved (up to 100 mGy/s) and
uncertainties with regard to the energy response of the DOSIMETER and the actual X-RAY
SPECTRUM. The DOSIMETER used for measurement of AIR KERMA shall conform to IEC 61674.
4.6.6 ATTENUATION layers
4.6.6.1 TEST DEVICES for AUTOMATIC EXPOSURE CONTROL (AEC) system
The ATTENUATION layers shall be made of PMMA. The thickness of ATTENUATION layers shall
be so that they can be stacked to form TEST DEVICEs of 20 mm, 40 mm, 60 mm and 70 mm.
The tolerances for the thickness shall be within ±1 mm, and the uniformity of the thickness
shall be within ±0,1 mm. The other dimensions shall be either semi-circular with a radius of at
least 100 mm, or rectangular with sides of at least 100 mm × 150 mm.
TTENUATION layers for first HALF-VALUE LAYER measurements
4.6.6.2 A
There shall be at least two different layers of aluminium foils. The thickness of the layers shall
be in the range from 0,2 mm to 0,6 mm, and should be chosen depending on the specified
first HALF-VALUE LAYERS. The foils shall be of 99,9 % purity. The thickness of the foils shall be
known within ±3 %.
NOTE Information on the chemical composition of aluminium can be found in EN 573-3.
4.6.7 Densitometer
The densitometer shall cover the optical density range 0 to 4,0 with an OVERALL UNCERTAINTY
that meets the conditions:
ΔD ≤ 0,02 (for D ≤ 1)
and | ΔD | / D ≤ 0,02 (for D > 1)
4.6.8 Compression force measuring device
A force scale with a range of at least 50 N to 300 N and an OVERALL UNCERTAINTY of less than
±5 N shall be used.
4.7 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 results concerning limit values (upper or lower), the uncertainty in the
measurement shall be taken into consideration.

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5 Test methods for mammographic X-RAY EQUIPMENT
5.1 Initial test and inventory
5.1.1 Requirements
The operation and functioning of the X-RAY EQUIPMENT shall comply with w
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