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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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

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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

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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