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    IEC 61223-3-2-2007 Evaluation and routine testing in medical imaging departments - Part 3-2 Acceptance tests - Imaging performance of mammographic X-ray equipme.pdf

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    IEC 61223-3-2-2007 Evaluation and routine testing in medical imaging departments - Part 3-2 Acceptance tests - Imaging performance of mammographic X-ray equipme.pdf

    1、 INTERNATIONAL STANDARD IECCEINORME INTERNATIONALE61223-3-2Second editionDeuxime dition2007-07Evaluation and routine testing in medical imaging departments Part 3-2: Acceptance tests Imaging performance of mammographic X-ray equipment Essais dvaluation et de routine dans les services dimagerie mdica

    2、le Partie 3-2: Essais dacceptation Performance dimagerie des appareils de mammographie rayonnement X Reference number Numro de rfrence IEC/CEI 61223-3-2:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of th

    3、is publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or

    4、have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise

    5、sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplment

    6、aires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is

    7、the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a

    8、 corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publicatio

    9、ns. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on t

    10、his publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des n

    11、ormes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut

    12、 avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications

    13、retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Service Clients: www.iec.ch/webstore/custserv/custserv

    14、_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 INTERNATIONAL STANDARD IECCEINORME INTERNATIONALE61223-3-2Second editionDeux

    15、ime dition2007-07Evaluation and routine testing in medical imaging departments Part 3-2: Acceptance tests Imaging performance of mammographic X-ray equipment Essais dvaluation et de routine dans les services dimagerie mdicale Partie 3-2: Essais dacceptation Performance dimagerie des appareils de mam

    16、mographie rayonnement X XB Commission Electrotechnique InternationaleInternational Electrotechnical Commission PRICE CODE CODE PRIX For price, see current cataloguePour 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

    17、 and definitions .9 4 General aspects of the ACCEPTANCE TEST12 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 conditions14 4.5 Scope of tests .14 4.6 Test EQUIPMENT .15 4.7 Evaluating the test results .16 5 Test methods for

    18、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 KER

    19、MA 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 Uniformity28 5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image receptors, including storage phosphor systems .30

    20、 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

    21、 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 RECEPTOR43 Annex C (informative) Test methods for screen-film X-ray image receptor .44 Anne

    22、x 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 s

    23、ystems 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 (no

    24、rmative) 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-uniformities57 Annex L (informative) Cross reference and history.59 Bibliography60 Terminology Index of defined terms .62 Figur

    25、e 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 methods42 Figure B.1 Test object for the dynamic range (to be used

    26、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 function51 Figure H.1 Example of a mammographic stereotactic TEST DEVICE54 Figure I.1 Set-up for HALF-VALUE LAYER measurements.55 Figure J.1 Definition of the R

    27、OIs 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 differe

    28、nt 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. 200050 Table L.1 Cross referen

    29、ce list for Editions 1 and 2 of this standard 59 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 Electrotechnica

    30、l 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 en

    31、d 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 Comm

    32、ittee 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 ac

    33、cordance 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

    34、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 res

    35、ponsible 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 diverge

    36、nce 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)

    37、 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 damag

    38、e 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 publi

    39、cation. 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 su

    40、ch 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 technic

    41、al 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 cont

    42、ent of the first and second editions. 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 publica

    43、tion 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

    44、: 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 Whe

    45、re 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

    46、 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

    47、the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 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 diagnos

    48、tic 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 MAMMOGRAPH

    49、IC STEREOTACTIC DEVICES. 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 wi


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