IEC 61223-3-6:2020

IEC 61223-3-6 ®
Edition 1.0 2020-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Evaluation and routine testing in medical imaging departments –
Part 3-6: Acceptance and constancy tests – Imaging performance
of mammographic X-ray equipment used in a mammographic tomosynthesis
mode of operation
Essais d'évaluation et de routine dans les services d'imagerie médicale –
Partie 3-6: Essais d'acceptation et de constance – Performance d'imagerie
des appareils de mammographie à rayonnement X utilisés en mode
tomosynthèse en mammographie
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IEC 61223-3-6 ®
Edition 1.0 2020-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Evaluation and routine testing in medical imaging departments –

Part 3-6: Acceptance and constancy tests – Imaging performance

of mammographic X-ray equipment used in a mammographic tomosynthesis

mode of operation
Essais d'évaluation et de routine dans les services d'imagerie médicale –

Partie 3-6: Essais d'acceptation et de constance – Performance d'imagerie

des appareils de mammographie à rayonnement X utilisés en mode

tomosynthèse en mammographie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-7812-3

– 2 – IEC 61223-3-6:2020 © IEC 2020
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope and object . 9
2 Normative references . 9
3 Terms, definitions, symbols and abbreviated terms . 10
3.1 Terms and definitions. 10
3.2 Symbols and abbreviated terms . 13
4 General aspects of the ACCEPTANCE TEST . 13
4.1 Levels of requirements . 13
4.1.1 Local regulatory . 13
4.1.2 Contractual . 13
4.1.3 General . 13
4.2 General conditions in test procedures . 13
4.3 Documents and data for the tests. 14
4.4 Test conditions . 14
4.5 Scope of tests . 15
4.6 Test equipment . 15
4.6.1 General . 15
4.6.2 Analysis software . 16
4.6.3 DOSIMETER . 16
4.7 Evaluating the test results . 16
5 General aspects of CONSTANCY TESTS . 17
5.1 Establishment of BASELINE VALUES . 17
5.2 Frequency of CONSTANCY TESTS . 17
6 Summary of tests for MAMMOGRAPHIC TOMOSYNTHESIS equipment . 17
7 Inventory and initial tests for MAMMOGRAPHIC TOMOSYNTHESIS equipment . 18
7.1 Requirements . 18
7.2 Test method . 19
7.3 CONSTANCY TESTING . 19
7.3.1 Test method . 19
7.3.2 Frequency of testing . 19
7.4 Action to be taken . 19
8 Alignment and collimation checks . 19
8.1 Requirements . 19
8.2 Test method . 19
8.3 CONSTANCY TESTING . 20
8.3.1 Test method . 20
8.3.2 Frequency of testing . 20
8.4 Equipment . 20
8.5 Action to be taken . 20
9 AEC-system . 20
9.1 General . 20
9.2 Short term reproducibility . 21
9.2.1 Requirements . 21
9.2.2 Test method . 21
9.2.3 CONSTANCY TESTING . 21

9.2.4 Equipment . 21
9.2.5 Action to be taken . 21
9.3 Long term reproducibility . 21
9.3.1 Requirements . 21
9.3.2 Test method . 22
9.3.3 CONSTANCY TESTING . 22
9.3.4 Action to be taken . 22
9.4 AEC performance . 22
9.4.1 Requirements . 22
9.4.2 Test method . 22
9.4.3 CONSTANCY TESTING . 25
9.4.4 Equipment . 25
9.4.5 Action to be taken . 25
10 Image receptor . 25
10.1 Response function . 25
10.1.1 General . 25
10.1.2 Requirements . 26
10.1.3 Test method . 26
10.1.4 CONSTANCY TESTING . 26
10.1.5 Action to be taken . 26
10.2 Detector element failure . 27
10.2.1 Requirements . 27
10.2.2 Test method . 27
10.2.3 CONSTANCY TESTING . 27
10.2.4 Equipment . 27
10.2.5 Action to be taken . 27
10.3 Uncorrected DEFECTIVE DETECTOR ELEMENTS . 27
10.3.1 General . 27
10.3.2 Requirements . 27
10.3.3 Test method . 27
10.3.4 CONSTANCY TESTING . 28
10.3.5 Equipment . 28
10.3.6 Action to be taken . 28
10.4 System PROJECTION MTF . 28
10.4.1 General . 28
10.4.2 Requirements . 28
10.4.3 Test method . 29
10.4.4 CONSTANCY TESTING . 29
10.4.5 Equipment . 29
10.4.6 Action to be taken . 29
11 Image quality of the reconstructed image . 29
11.1 PHANTOM testing . 29
11.1.1 General . 29
11.1.2 Requirements . 29
11.1.3 Test method . 30
11.1.4 CONSTANCY TESTING . 30
11.1.5 Action to be taken . 30
11.2 z-resolution (ARTEFACT spread function) . 30
11.2.1 Requirements . 30

– 4 – IEC 61223-3-6:2020 © IEC 2020
11.2.2 Test method . 30
11.2.3 CONSTANCY TESTING . 32
11.2.4 Equipment . 32
11.2.5 Action to be taken . 32
12 Missed tissue . 32
12.1 General . 32
12.2 Missed tissue at chest wall side in the reconstructed tomosynthesis volume . 33
12.2.1 Requirements . 33
12.2.2 Test method . 33
12.2.3 CONSTANCY TESTING . 33
12.2.4 Equipment . 33
12.2.5 Action to be taken . 33
12.3 Missed tissue at the top and bottom of the reconstructed tomosynthesis
volume . 33
12.3.1 Requirements . 33
12.3.2 Test method . 33
12.3.3 CONSTANCY TESTING . 34
12.3.4 Equipment . 35
12.3.5 Action to be taken . 35
13 ARTEFACTS in the tomosynthesis data sets . 35
13.1 General . 35
13.2 ARTEFACT evaluation . 35
13.2.1 Requirements . 35
13.2.2 Test method . 35
13.2.3 CONSTANCY TESTING . 35
13.2.4 Equipment . 35
13.2.5 Action to be taken . 35
13.3 GEOMETRIC DISTORTION . 35
13.3.1 Requirements . 35
13.3.2 Test method . 36
13.3.3 Equipment . 37
13.3.4 Action to be taken . 37
14 Dosimetry for digital breast tomosynthesis . 37
14.1 Requirements . 37
14.2 Test method . 38
14.3 CONSTANCY TESTING . 39
14.3.1 Test method . 39
14.3.2 Frequency of testing . 39
14.4 Equipment . 39
14.5 Action to be taken . 39
Annex A (informative) Tables for dosimetry calculation in digital breast tomosynthesis . 40
Annex B (normative) Guidance on action to be taken . 44
B.1 Failing the ESTABLISHED CRITERIA at first measurement . 44
B.2 Failing the ESTABLISHED CRITERIA at multiple measurements . 44
B.3 Marginally failing the ESTABLISHED CRITERIA . 44
B.4 History of repeatedly failing the ESTABLISHED CRITERIA . 44
B.5 Substantially failing the ESTABLISHED CRITERIA . 45
B.6 Cases not covered by Clauses B.1 to B.5 . 45

Annex C (informative) Image quality evaluation . 46
Annex D (informative) ARTEFACTS . 47
Bibliography . 48
Index of defined terms . 52

Figure 1 – Set-up for measuring the alignment between the reconstructed and the
irradiated volume at the chest wall edge of the PATIENT SUPPORT. 20
Figure 2 – Top and 3D view of setup for the AEC performance measurements . 23
Figure 3 – Placement of ROI for the AEC performance measurement . 24
Figure 4 – Top and 3D view of setup for the evaluation of z-resolution . 31
Figure 5 – Front and side view of setup for the evaluation of z-resolution . 32
Figure 6 – Configuration for the determination of missed tissue for curved paddles . 34
Figure 7 – Top and 3D view of setup for the evaluation of GEOMETRIC DISTORTION . 36
Figure 8 – Front and side view of setup for the evaluation of GEOMETRIC DISTORTION . 37
Figure 9 –Top and 3D view of position of DOSIMETER to determine the incident AIR
KERMA for dose estimation . 39

Table 1 – Tests, test frequencies, and test objects used in this document . 17
Table 2 – Height of the compression paddle when using different PMMA thicknesses . 24
Table 3 – Limits for AGD versus the thickness of the PMMA and the height of the
compression paddle . 38
Table A.1 – g factors for breasts simulated with PMMA . 40
Table A.2 – c factors for breasts simulated with PMMA . 40
Table A.3 – Typical HVL measurements for different tube voltage and TARGET FILTER
combinations . 41
Table A.4 – s factors for clinically used spectra . 41
Table A.5 – s factors for clinically used spectra with W TARGET material . 41
Table A.6 – s factors for a tungsten TARGET filtered by 0,5 mm aluminium. 42
Table A.7 – s factors for a tungsten TARGET filtered by 0,7 mm aluminium. 42
Table A.8 – T factors vs. PMMA thickness for a variety of scan angles . 43

– 6 – IEC 61223-3-6:2020 © IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-6: Acceptance and constancy tests –
Imaging performance of mammographic X-ray equipment used in a
mammographic tomosynthesis mode of operation

FOREWORD
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61223-3-6 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this International Standard is based on the following documents:
CDV Report on voting
62B/1127/CDV 62B/1148/RVC
Full information on the voting for the approval of this International Standard can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type.
– explanations, advice, notes, general statements, exceptions and references: in smaller type;
– TERMS USED THROUGHOUT THIS DOCUMENT THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED
TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: IN SMALL CAPITALS.
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.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of the users of this document is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

– 8 – IEC 61223-3-6:2020 © IEC 2020
INTRODUCTION
IEC 61223 (all parts) gives methods for ACCEPTANCE TESTS and CONSTANCY TESTS for diagnostic
X-RAY EQUIPMENT.
This part of IEC 61223 describes test methods for the ACCEPTANCE and CONSTANCY TESTS of
MAMMOGRAPHIC X-RAY EQUIPMENT used in a MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION.

EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-6: Acceptance and constancy tests –
Imaging performance of mammographic X-ray equipment used in a
mammographic tomosynthesis mode of operation

1 Scope and object
This part of IEC 61223 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when
used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and
dose.
Excluded from the scope of this document are:
– MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC
TOMOSYNTHESIS;
– 2D images synthesised from the tomosynthesis images;
– reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS;
– CT SCANNERS covered by IEC 61223-3-5.
This document defines:
a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC
TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to
image quality and dose,
b) the methods of testing whether measured quantities related to those parameters comply
with specified tolerances, and
c) CONSTANCY TEST frequency when required.
This document is intended to be applied along with the acceptability criteria included in
IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for
MAMMOGRAPHIC TOMOSYNTHESIS modes of operation.
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.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the
BASELINE VALUES for the subsequent CONSTANCY TESTS are established.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 60601-2-45:2011, Medical electrical equipment – Part 2-45: Particular requirements for
basic safety and essential performance of mammographic X-ray equipment and mammographic
stereotactic devices
IEC 60601-2-45:2011/AMD1:2015
– 10 – IEC 61223-3-6:2020 © IEC 2020
IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments – Part 3-
2: Acceptance tests – Imaging performance of mammographic X-ray equipment
IEC 61674:2012, Medical electrical equipment – Dosimeters with ionization chambers and/or
semiconductor detectors as used in X-ray diagnostic imaging
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-2-45,
IEC 61223-3-2 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1.1
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 contractual specifications
[SOURCE: IEC TR 61223-1:1993, 3.2.4]
3.1.2
ARTEFACT
apparent structure, visible in the image, which does not represent a structure within the object
[SOURCE: IEC 61223-3-4:2000, 3.3.1]
3.1.3
AUTOMATIC EXPOSURE CONTROL
AEC
MODE OF OPERATION, in a radiological equipment, 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 a specified quantity of RADIATION of a desired quality
Note 1 to entry: Examples of such properties of the object are: thickness, composition, or X-ray TRANSMISSION.
Examples for IRRADIATION conditions are anode materials of the X-RAY TUBE and ADDED FILTERS.
Note 2 to entry: This note applies to the French language only.
3.1.4
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
[SOURCE: IEC 61223-3-2:2007, 3.7]
3.1.5
BASELINE VALUE
reference value of functional parameter, which is either:
– the value obtained for this parameter in the initial CONSTANCY TEST immediately following a
STATUS TEST, or
– where described in a corresponding particular standard, the mean value of values obtained
in a series of initial CONSTANCY TESTS, immediately following a STATUS TEST

3.1.6
CONSTANCY TEST
CONSTANCY TESTING
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
Note 1 to entry: May use a subset of the ACCEPTANCE TEST.
[SOURCE: IEC TR 61223-1:1993, 3.2.6, modified – Note 1 to entry has been added.]
3.1.7
DIAGNOSTIC DOSIMETER
DOSIMETER
equipment which uses IONIZATION CHAMBERS and/or semiconductor 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
Note 1 to entry: 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.
[SOURCE: IEC 61674:2012, 3.1, modified – Note 1 to entry has been rephrased.]
3.1.8
ESTABLISHED CRITERIA
acceptable variations, in a QUALITY ASSURANCE PROGRAMME, in results of a CONSTANCY TEST
which signal satisfactory functional performance of the equipment tested
3.1.9
FOCAL SPOT
perpendicular PROJECTION of the actual FOCAL SPOT on the reference plane
Note 1 to entry: The shortened term "FOCAL SPOT" refers to the effective FOCAL SPOT (IEC 60806 [1] ).
3.1.10
LINEARIZED DATA
ORIGINAL DATA to which the inverse CONVERSION FUNCTION has been applied
Note 1 to entry: The LINEARIZED DATA are directly proportional to the AIR KERMA.
Note 2 to entry: For practical reasons, AIR KERMA proportional data can be generated by applying the inverse
response function (see 10.1.3).
[SOURCE: IEC 62220-1-2:2007, 3.7, modified – Note 2 to entry has been added.]
3.1.11
MAMMOGRAPHIC TOMOSYNTHESIS
DBT
technique using MAMMOGRAPHIC X-RAY EQUIPMENT to produce multiple tomographic images
reconstructed from multiple PROJECTIONS acquired over a total angular range of less than 180°
Note 1 to entry: This note applies to the French language only.
[SOURCE: IEC 60601-2-45:2011 and IEC 60601-2-45:2011/AMD1:2015, 201.3.210, modified –
The abbreviated term "DBT" has been added, as well as Note 1 to entry.]
___________
Numbers in square brackets refer to the Bibliography.

– 12 – IEC 61223-3-6:2020 © IEC 2020
3.1.12
MEASUREMENT UNCERTAINTY
non-negative parameter characterizing the dispersion of the quantity values being attributed to
a measurand, based on the information used
[SOURCE: ISO/IEC Guide 99:2007, 2.26, modified – The notes to entry have been deleted.]
3.1.13
ORIGINAL DATA
RAW DATA to which the corrections as in normal clinical use have been applied
Note 1 to entry: 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.
Note 2 to entry: See IEC 60601-2-45:2011, 201.3.208.
3.1.14
QUALITY ASSURANCE PROGRAMME
detailed instruction for carrying out actions of quality assurance for individual items of
equipment, systems of equipment or facilities, including quality administrative elements and
QUALITY CONTROL techniques
3.1.15
RAW DATA
PIXEL values read directly after the analogue-digital-conversion from the DIGITAL X-RAY IMAGING
or counts from photon counting systems without any corrections
DEVICE
[SOURCE: IEC 60601-2-45:2011, 201.3.209, modified – The word "software" has been deleted
in "software corrections".]
3.1.16
REFERENCE ROI
REGION OF INTEREST (size 5 mm x 5 mm) in the PROJECTION
Note 1 to entry: The centre of the ROI is positioned 60 mm perpendicular to the chest edge of the PATIENT SUPPORT
and centred laterally.
Note 2 to entry: This note applies to the French language only.
3.1.17
SIGNAL DIFFERENCE TO NOISE RATIO
SDNR
ratio, in a digital image, of the difference of mean PIXEL values of the contrast object and image
background and the standard deviation of the image background PIXEL value
Note 1 to entry: This note applies to the French language only.
3.1.18
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
Note 1 to entry: This note applies to the French language only.
3.1.19
STATUS TEST
test carried out to establish the functional status of equipment at a given time

3.1.20
ZERO DEGREE ANGLE STATIONARY MODE
MODE OF OPERATION of the tomosynthesis equipment identical to a tomosynthesis mode, without
the tomosynthesis movement of the X-RAY BEAM with the PATIENT SUPPORT surface positioned
horizontally and the beam axis as close as possible perpendicular to it
3.2 Symbols and abbreviated terms
Symbol/abbreviated
Physical quantity/Description Unit
term
K ENTRANCE SURFACE AIR KERMA mGy
E
FWHM full width at half maximum mm
MTF MODULATION TRANSFER FUNCTION -
PMMA polymethylmethacrylate -
ROI region of interest -
4 General aspects of the ACCEPTANCE TEST
4.1 Levels of requirements
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.
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.
The aim of the ACCEPTANCE TEST is to demonstrate that the specified characteristics of the
equipment lie within specified tolerances. These tolerances are determin
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