SIST EN IEC 61223-3-6:2020

SLOVENSKI STANDARD
01-julij-2020
Ovrednotenje in kosovno preskušanje v medicinskih oddelkih za slikanje - 3-6. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek mamografske
rentgenske opreme, ki se uporablja v mamografskem načinu delovanja
tomosinteze (IEC 61223-3-6:2020)
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 (IEC 61223-3-6:2020)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-6: Abnahmeprüfungen und Konstanzprüfungen – Leistungsmerkmale zur Bildgebung
im mammographischen Tomosynthese-Betrieb von Röntgen-Mammographiegeräten
(IEC 61223-3-6:2020)
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
(IEC 61223-3-6:2020)
Ta slovenski standard je istoveten z: EN IEC 61223-3-6:2020
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61223-3-6

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.50
English Version
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
(IEC 61223-3-6:2020)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-6: Essais d'acceptation et de medizinische Bildgebung - Teil 3-6: Abnahmeprüfungen und
constance - Performance d'imagerie des appareils de Konstanzprüfungen – Leistungsmerkmale zur Bildgebung
mammographie à rayonnement X utilisés en mode im mammographischen Tomosynthese-Betrieb von
tomosynthèse en mammographie Röntgen-Mammographiegeräten
(IEC 61223-3-6:2020) (IEC 61223-3-6:2020)
This European Standard was approved by CENELEC on 2020-03-13. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61223-3-6:2020 E

European foreword
The text of document 62B/1127/CDV, future edition 1 of IEC 61223-3-6, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61223-3-6:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-12-13
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-03-13
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 61223-3-6:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60806:1984 NOTE Harmonized as EN 60806:2004 (not modified)
IEC 62220-1-2:2007 NOTE Harmonized as EN 62220-1-2:2007 (not modified)
IEC 61223-3-4:2000 NOTE Harmonized as EN 61223-3-4:2000 (not modified)
IEC 60544-1:2013 NOTE Harmonized as EN 60544-1:2013 (not modified)
IEC 62132-1:2015 NOTE Harmonized as EN 62132-1:2016 (not modified)
IEC 60601-2-44:2009 NOTE Harmonized as EN 60601-2-44:2009 (not modified)
IEC 62220-1-1:2015 NOTE Harmonized as EN 62220-1-1:2015 (not modified)
IEC 62464-1:2018 NOTE Harmonized as EN IEC 62464-1:2019 (not modified)
IEC 61223-3-5:2019 NOTE Harmonized as EN IEC 61223-3-5:2019 (not modified)
IEC 60601-1-3:2008 NOTE Harmonized as EN 60601-1-3:2008 (not modified)
IEC 62563-1 NOTE Harmonized as EN 62563-1
IEC 60627 NOTE Harmonized as EN 60627
IEC 60601-2-28 NOTE Harmonized as EN IEC 60601-2-28
IEC 61223-3-4:2000 NOTE Harmonized as EN 61223-3-4:2000 (not modified)
IEC 60601-2-64:2014 NOTE Harmonized as EN 60601-2-64:2015 (not modified)
IEC 61675-2:2015 NOTE Harmonized as EN 61675-2:2015 (not modified)
IEC 80601-2-59:2017 NOTE Harmonized as EN IEC 80601-2-59:2019 (not modified)
IEC 60730-1:2013 NOTE Harmonized as EN 60730-1:2016 (modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-2-45 2011 Medical electrical equipment - Part 2-45: EN 60601-2-45 2011
Particular requirements for basic safety and
essential performance of mammographic X-ray
equipment and mammomagraphic stereotactic
devices
+ A1 2015 + A1 2015
IEC 61223-3-2 2007 Evaluation and routine testing in medical EN 61223-3-2 2008
imaging departments - Part 3-2: Acceptance
tests - Imaging performance of mammographic
X-ray equipment
IEC 61674 2012 Medical electrical equipment - Dosimeters with EN 61674 2013
ionization chambers and/or semiconductor
detectors as used in X-ray diagnostic imaging

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

IEC 61223-3-6:2020 © IEC 2020 – 3 –
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

IEC 61223-3-6:2020 © IEC 2020 – 5 –
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
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, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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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 61223-3-6 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.

IEC 61223-3-6:2020 © IEC 2020 – 7 –
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.

IEC 61223-3-6:2020 © IEC 2020 – 9 –
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

IEC 61223-3-6:2020 © IEC 2020 – 11 –
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
...