1、BRITISH STANDARDBS EN 61223-3-2:2008Evaluation and routine testing in medical imaging departments Part 3-2: Acceptance tests Imaging performance of mammographic X-ray equipmentICS 11.040.50g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g5
2、1g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 61223-3-2:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2008 BSI 2008ISBN 978 0 580 55611 1National forewordThis British Standar
3、d is the UK implementation of EN 61223-3-2:2008. It is identical to IEC 61223-3-2:2007. It supersedes BS EN 61223-3.2:1997 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/2, Dia
4、gnostic imaging equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard ca
5、nnot confer immunity from legal obligations.Amendments/corrigenda issued since publicationDate CommentsEUROPEAN STANDARD EN 61223-3-2 NORME EUROPENNE EUROPISCHE NORM July 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches
6、Komitee fr 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 ICS 11.040.50 Supersedes EN 61223-3-2:1996English version Evalua
7、tion 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 dvaluation et de routine dans les services dimagerie mdicale - Partie 3-2: Essais dacceptation - Performance dimagerie des appareils
8、de mammographie rayonnement X (CEI 61223-3-2:2007) Bewertung und routinemige Prfung in Abteilungen fr medizinische Bildgebung - Teil 3-2: Abnahmeprfungen - Leistungsmerkmale zur Bildgebung von Rntgen-Einrichtungen fr die Mammographie (IEC 61223-3-2:2007) This European Standard was approved by CENELE
9、C 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
10、 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
11、 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, L
12、uxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 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 equip
13、ment 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,
14、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
15、at national level by publication of an identical national standard or by endorsement (dop) 2009-03-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2011-06-01 In this standard, the following print types are used: requirements, compliance with which ca
16、n 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 qualifi
17、er 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 ab
18、ove, a corresponding term is printed in lower case letters. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61223-3-2:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 61223-3-2:2008 2 CONTENTS INTRODUCTION.5 1 S
19、cope.6 2 Normative references .7 3 Terms and definitions .8 4 General aspects of the ACCEPTANCE TEST11 4.1 Levels of compliance.11 4.2 General conditions in test procedures .11 4.3 Documents and data for the tests 12 4.4 Test conditions13 4.5 Scope of tests .13 4.6 Test EQUIPMENT .14 4.7 Evaluating
20、the test results .15 5 Test methods for mammographic X-RAY EQUIPMENT 16 5.1 Initial test and inventory 16 5.2 X-RAY TUBE VOLTAGE 16 5.3 HALF VALUE LAYER (HVL) 17 5.4 NOMINAL FOCAL SPOT VALUE 18 5.5 X-RAY FIELD limitation and beam alignment 18 5.6 Radiation output 19 5.7 AUTOMATIC EXPOSURE CONTROL (A
21、EC)19 5.8 Reproducibility of the AIR KERMA 25 5.9 ATTENUATION RATIO of material between the upper surface of the PATIENT SUPPORT and the IMAGE RECEPTION PLANE.25 5.10 Breast COMPRESSION DEVICE 26 5.11 Uniformity27 5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image receptors
22、, including storage phosphor systems .29 5.13 Spatial resolution 30 5.14 LOW CONTRAST DETECTABILITY 33 5.15 Entrance surface AIR KERMA.34 5.16 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES .35 6 Baseline values for CONSTANCY TESTS .36 7 Test report and statement of complian
23、ce 36 Annex A (informative) TEST DEVICES and arrangements for testing the automatic exposure control system with a digital X-RAY IMAGE RECEPTOR.38 Annex B (informative) TEST DEVICE for testing the dynamic range of systems with a digital X-RAY IMAGE RECEPTOR42 Annex C (informative) Test methods for s
24、creen-film X-ray image receptor .43 Annex D (informative) Test methods for storage phosphor system .45 BS EN 61223-3-2:2008 3 Annex E (informative) Example of a method for the determination of the AVERAGE GLANDULAR DOSE .48 Annex F (informative) Example of TEST DEVICES and arrangements for testing t
25、he system contrast transfer function for systems with a digital X-RAY IMAGE RECEPTOR.50 Annex G (informative) LOW CONTRAST DETECTABILITY test for mammographic X-RAY EQUIPMENT using an integrated digital X-RAY IMAGE RECEPTOR or storage phosphor plates .51 Annex H (informative) Example of a mammograph
26、ic stereotactic TEST DEVICE 53 Annex I (normative) Set-up for HALF-VALUE LAYER measurements .54 Annex J (informative) Definition of the ROIs for testing lag effects .55 Annex K (informative) ARTIFACTS and other non-uniformities56 Annex L (informative) Cross reference and history.58 Bibliography59 Te
27、rminology Index of defined terms .61 Figure A.1 Basic ATTENUATION Plates.38 Figure A.2 Alternative design for the top attenuating plate .39 Figure A.3 Alternative design for the two additional attenuating plates (two pieces required).40 Figure A.4 Measurement of CNR: 2-step methods41 Figure B.1 Test
28、 object for the dynamic range (to be used together with a 20 mm PMMA plate placed on top).42 Figure F.1 Example of 45 test pattern for the evaluation of the system contrast transfer function50 Figure H.1 Example of a mammographic stereotactic TEST DEVICE53 Figure I.1 Set-up for HALF-VALUE LAYER meas
29、urements.54 Figure J.1 Definition of the ROIs for testing lag effects.55 Table 1 Symbols, physical quantities, abbreviations and units used in this standard 10 Table 2 Examples of typical HALF-VALUE LAYERS (HVL) in millimetres of aluminium (mm Al) for mammographic X-RAY EQUIPMENT with different TARG
30、ET FILTER combinations operated at different X-RAY TUBE VOLTAGES .17 Table E.1 g for breasts simulated with PMMA 49 Table E.2 c for breasts simulated with PMMA 49 Table E.3 Typical HVL measurements for different tube voltage and TARGET FILTER combinations 49 Table E.4 s for clinically used spectra D
31、ance et al. 200049 Table L.1 Cross reference list for Editions 1 and 2 of this standard 58 BS EN 61223-3-2:2008 4 Annex ZA (normative) Normative references to international publications with theircorresponding European publications63INTRODUCTION This standard is part of a series of International Sta
32、ndards 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
33、 plates, EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS, and MAMMOGRAPHIC STEREOTACTIC DEVICES. BS EN 61223-3-2:2008 5 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
34、 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 qualit
35、y 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 a
36、s 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
37、 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 w
38、ith 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
39、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 proced
40、ure 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. BS EN 61223-3-2:2008 6 This standard does not in itself specify limiting values or tolerances for the
41、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 an
42、d 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 syste
43、m 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 re
44、quires 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
45、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 equip
46、ment 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, E
47、valuation 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 Dosimetr
48、ic 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 radiogra
49、phy Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography BS EN 61223-3-2:2008 7 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 Table 1. 3.1 ACCEPTANCE TEST test carried out after new EQUIPMENT has been installed, or major modifications have been mad
