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. 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. 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.

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: 24-Jul-2008
• Withdrawal Date: 31-May-2011
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 25-Jul-2008
• Completion Date: 25-Jul-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: 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

Relations

• Replaces: EN 61223-3-2:1996 - 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

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
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.
__________
- 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).
__________
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.

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) Exam
...