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)

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.

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)

L'IEC 61223-3-6:2020 s'applique aux performances des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X utilisés en mode TOMOSYNTHESE EN MAMMOGRAPHIE, en matière de qualité d'image et de dose. Sont exclus du domaine d'application du présent document: - les modes de fonctionnement des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X autres que la TOMOSYNTHESE EN MAMMOGRAPHIE; - les images 2D synthétisées à partir d'images de tomosynthèse; - la TOMOGRAPHIE reconstructrice autre que la TOMOSYNTHESE EN MAMMOGRAPHIE; - les TOMODENSITOMETRES couverts par l'IEC 61223-3-5. L'IEC 61223-3-6:2020 définit: a) les paramètres essentiels qui décrivent les critères d'acceptabilité des modes TOMOSYNTHESE EN MAMMOGRAPHIE des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X en matière de qualité d'image et de dose; b) les méthodes d'essai visant à déterminer si les grandeurs mesurées liées à ces paramètres sont conformes aux tolérances spécifiées; et c) la fréquence d'ESSAI DE CONSTANCE, le cas échéant. Le présent document est destiné à s'appliquer avec les critères d'acceptabilité inclus dans l'IEC 61223-3-2 ou un protocole de mammographie 2D équivalent, lesquels s'appliquent également aux modes TOMOSYNTHESE EN MAMMOGRAPHIE. Ces méthodes reposent principalement sur des mesures non invasives, exécutées pendant ou après l'installation, en utilisant des équipements d'essai appropriés. Des déclarations signées couvrant des étapes de la procédure d'installation peuvent être utilisées dans le cadre de l'ESSAI D'ACCEPTATION. Les essais exigés par un niveau de conformité plus élevé prévalent sur les essais similaires associés à un niveau de conformité plus faible. Lorsque les résultats de l'ESSAI D'ACCEPTATION sont conformes aux valeurs attendues, les VALEURS DE BASE des ESSAIS DE CONSTANCE ultérieurs sont établies.

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)

General Information

Status
Published
Publication Date
06-May-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
07-May-2020

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SLOVENSKI STANDARD
SIST EN IEC 61223-3-6:2020
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
SIST EN IEC 61223-3-6:2020 en

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

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SIST EN IEC 61223-3-6:2020
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SIST EN IEC 61223-3-6:2020
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
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SIST EN IEC 61223-3-6:2020
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)
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SIST EN IEC 61223-3-6:2020
EN IEC 61223-3-6:2020 (E)
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
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SIST EN IEC 61223-3-6:2020
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SIST EN 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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-7812-3

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 61223-3-6:2020
– 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

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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

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SIST EN IEC 61223-3-6:2020
– 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

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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

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