SIST EN 61223-3-2:2008

Evaluation and routine testing in medical imaging departments -- Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment

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.

Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-2: Abnahmeprüfungen - Leistungsmerkmale zur Bildgebung von Röntgen-Einrichtungen für die Mammographie

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

La présente partie de la CEI 61223 s'applique à l'efficacité des appareils de mammographie a rayonnement X, en ce qui concerne la qualité d'image et la dose, avec les aspects de sécurité des appareils.  La présente norme s'applique aux appareils de mammographie a rayonnement X et aux appareils de mammographie stéréotaxique. Les essais décrits dans la présente norme exigent que la qualité et les performances des récepteurs d'images radiologiques soient assurées avant que ne soient effectués préalablement les essais d'acceptation lorsqu'ils ne font pas partie intégrante de l'appareil de mammographie a rayonnement X. Cela comprend les films radiographiques, les écrans renforçateurs, les cassettes radiographiques, les plaques luminophores à mémoire et les appareils associes tels que les appareils de traitement de film ou les lecteurs de plaque luminophore à mémoire, les dispositifs de visualisation d'images et les reprographes. Pour les essais de cassettes radiographiques et d'écrans renforçateurs, la présente norme fait référence à l'ISO 4090. La sensibilité et le contraste pour les récepteurs d'images écran-film sont considérés comme étant définis conformément à l'ISO 9236-3. Les mesures décrites dans la présente norme permettent de déterminer des données pour le calcul de la dose glandulaire moyenne. Lorsque les résultats de l'essai d'acceptation sont conformes aux valeurs prévues, les valeurs de base pour les essais de constance ultérieurs sont établies. La présente partie de la CEI 61223 définit a) les paramètres essentiels décrivant les performances des appareils de mammographie a rayonnement X ci-dessus en ce qui concerne la qualité de l'image et la dose; et b) les méthodes permettant de vérifier si les quantités mesurées, liées à ces paramètres, sont conformes aux tolérances spécifiées. Ces méthodes reposent essentiellement sur des mesures non invasives utilisant des appareils d'essai convenables et effectuées au cours de l'installation ou après celle-ci. Des rapports certifiés couvrant les étapes de la procédure d'installation peuvent être utilisés dans le cadre de l'essai d'acceptation. Les essais exigés par un niveau plus élevé de conformité sont prioritaires sur des essais similaires avec un niveau inférieur de conformité.",PE

Ovrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-2. del: Preskusi sprejemljivosti - Slikovni učinek rentgenske opreme za mamografijo (IEC 61223-3-2:2007)

General Information

• Status: Published
• Publication Date: 22-Sep-2008
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Sep-2008
• Due Date: 20-Nov-2008
• Completion Date: 23-Sep-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 61223-3-2:2008 - Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment

Relations

• Replaces: SIST EN 61223-3-2:1998 - Evaluation and routine testing in medical imaging departments -- Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 61223-3-2:1998 - Evaluation and routine testing in medical imaging departments -- Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
• Effective Date: 01-Sep-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61223-3-2:2008
01-november-2008
2YUHGQRWHQMHLQUXWLQVNRSUHVNXãDQMHYPHGLFLQVNLKRGGHONLK]DVOLNDQMHGHO
3UHVNXVLVSUHMHPOMLYRVWL6OLNRYQLXþLQHNUHQWJHQVNHRSUHPH]DPDPRJUDILMR,(&

Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance
tests - Imaging performance of mammographic X-ray equipment (IEC 61223-3-2:2007)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-2: Abnahmeprüfungen - Leistungsmerkmale zur Bildgebung von Röntgen-
Einrichtungen für die Mammographie (IEC 61223-3-2:2007)
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 (CEI 61223-3-2:2007)
Ta slovenski standard je istoveten z: EN 61223-3-2:2008
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 61223-3-2:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61223-3-2:2008

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SIST EN 61223-3-2:2008

EUROPEAN STANDARD
EN 61223-3-2

NORME EUROPÉENNE
July 2008
EUROPÄISCHE NORM

ICS 11.040.50 Supersedes EN 61223-3-2:1996


English version


Evaluation and routine testing in medical imaging departments -
Part 3-2: Acceptance tests -
Imaging performance of mammographic X-ray equipment
(IEC 61223-3-2:2007)


Essais d'évaluation et de routine  Bewertung und routinemäßige Prüfung
dans les services d'imagerie médicale - in Abteilungen
Partie 3-2: Essais d'acceptation - für medizinische Bildgebung -
Performance d'imagerie des appareils Teil 3-2: Abnahmeprüfungen -
de mammographie à rayonnement X Leistungsmerkmale zur Bildgebung
(CEI 61223-3-2:2007) von Röntgen-Einrichtungen
für die Mammographie
(IEC 61223-3-2:2007)




This European Standard was approved by CENELEC on 2008-06-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61223-3-2:2008 E

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SIST EN 61223-3-2:2008
EN 61223-3-2:2008 - 2 -
Foreword
The text of document 62B/651/FDIS, future edition 2 of IEC 61223-3-2, 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 was approved by CENELEC as EN 61223-3-2 on 2008-06-01.
This European Standard supersedes EN 61223-3-2:1996.
EN 61223-3-2:2008 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 EN 61223-3-2:1996 and EN 61223-3-2:2008.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2009-03-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2011-06-01
with the EN have to be withdrawn
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/TR 60788, EN 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.
Annex ZA has been added by CENELEC.
__________

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SIST EN 61223-3-2:2008
- 3 - EN 61223-3-2:2008
Endorsement notice
The text of the International Standard IEC 61223-3-2:2007 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 60601-1-3 NOTE  Harmonized as EN 60601-1-3:2008 (not modified).
IEC 60601-2-28 NOTE  Harmonized as EN 60601-2-28:1993 (not modified).
IEC 60627 NOTE  Harmonized as EN 60627:2001 (not modified).
IEC 61223-2-4 NOTE  Harmonized as EN 61223-2-4:1994 (not modified).
IEC 61223-2-5 NOTE  Harmonized as EN 61223-2-5:1994 (not modified).
IEC 61223-3-1 NOTE  Harmonized as EN 61223-3-1:1999 (not modified).
IEC 61223-3-3 NOTE  Harmonized as EN 61223-3-3:1996 (not modified).
IEC 61223-3-4 NOTE  Harmonized as EN 61223-3-4:2000 (not modified).
IEC 62220-1-2 NOTE  Harmonized as EN 62220-1-2:2007 (not modified).
ISO 3386-1 NOTE  Harmonized as EN ISO 3386-1:1997 (not modified).
__________

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SIST EN 61223-3-2:2008
EN 61223-3-2:2008 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 60336 2005 Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots


IEC 60601 Series Medical electrical equipment EN 60601 Series


1) 2)
IEC 60601-1 - Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance


1) 2)
IEC 60601-2-45 - Medical electrical equipment - EN 60601-2-45 2001
Part 2-45: Particular requirements for the
safety of mammographic X-ray equipment and
mammographic stereotactic devices


1)
IEC/TS 61223-2-1 - Evaluation and routing testing in medical - -
imaging departments -
Part 2-1: Constancy tests - Film processors


1) 2)
IEC 61674 - Medical electrical equipment - Dosimeters EN 61674 1997
with ionization chambers and/or
semi-conductor detectors as used
in X-ray diagnostic imaging


IEC 61676 2002 Medical electrical equipment - Dosimetric EN 61676 2002
instruments used for non-invasive
measurement of X-ray tube voltage in
diagnostic radiology


1)
ISO 4090 - Photography - Medical radiographic - -
cassettes/screens/films and hard-copy
imaging films - Dimensions and specifications


1)
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




1)
Undated reference.
2)
Valid edition at date of issue.

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SIST EN 61223-3-2:2008
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

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SIST EN 61223-3-2:2008
– 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

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SIST EN 61223-3-2:2008
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

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SIST EN 61223-3-2:2008
– 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,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. IEC collaborates closely
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
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end USER.
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
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.

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SIST EN 61223-3-2:2008
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.

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SIST EN 61223-3-2:2008
– 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.

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SIST EN 61223-3-2:2008
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.

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SIST EN 61223-3-2:2008
– 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

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SIST EN 61223-3-2:2008
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 Tabl
...