BS-EN-61223-3-2-2008.pdf
《BS-EN-61223-3-2-2008.pdf》由会员分享,可在线阅读,更多相关《BS-EN-61223-3-2-2008.pdf(66页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS 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 ICS 11.040.50 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 03:37, Uncontrolled Copy, (c) BSI BS EN 61223-3-
2、2:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2008 BSI 2008 ISBN 978 0 580 55611 1 National foreword This British Standard is the UK implementation of EN 61223-3-2:2008. It is identical to IEC 61223-3-2:2007. It supersed
3、es BS EN 61223-3.2:1997 which is withdrawn.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, Diagnostic imaging equipment. A list of organizations represented on this committee can be obtained o
4、n 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 cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication Dat
5、eComments Licensed CopyChinese University of Hong Kong, 21/10/2008 03:37, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 61223-3-2 NORME EUROPENNE EUROPISCHE NORM July 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Ko
6、mitee 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 61223-3-2:1996 English version Evaluat
7、ion 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 d
8、e 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 CENELEC
9、 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, Lu
12、xembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed CopyChinese University of Hong Kong, 21/10/2008 03:37, Uncontrolled Copy, (c) BSI Foreword The text of document 62B/651/FDIS, future edition 2 of IEC 6
13、1223-3-2, 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. EN 61223-3-2:2008 has bee
14、n 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 content of EN 61223-3-2:1996 and EN 61223-3-
15、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 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
16、 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: SMA
17、LL 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 addre
18、ssed 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. _ Endorsement notice The text of the International Standard IEC 61223-3-2:2007 was approved by CENELEC as a Europe
19、an Standard without any modification. _ BS EN 61223-3-2:2008 2 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:37, Uncontrolled Copy, (c) BSI CONTENTS INTRODUCTION.5 1 Scope.6 2 Normative references .7 3 Terms and definitions .8 4 General aspects of the ACCEPTANCE TEST11 4.1 Levels of co
20、mpliance.11 4.2 General conditions in test procedures .11 4.3 Documents and data for the tests12 4.4 Test conditions13 4.5 Scope of tests .13 4.6 Test EQUIPMENT.14 4.7 Evaluating the test results .15 5 Test methods for mammographic X-RAY EQUIPMENT16 5.1 Initial test and inventory 16 5.2 X-RAY TUBE V
21、OLTAGE16 5.3 HALF VALUE LAYER (HVL)17 5.4 NOMINAL FOCAL SPOT VALUE18 5.5 X-RAY FIELD limitation and beam alignment 18 5.6 Radiation output19 5.7 AUTOMATIC EXPOSURE CONTROL (AEC)19 5.8 Reproducibility of the AIR KERMA25 5.9 ATTENUATION RATIO of material between the upper surface of the PATIENT SUPPOR
22、T and the IMAGE RECEPTION PLANE.25 5.10 Breast COMPRESSION DEVICE26 5.11 Uniformity27 5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital X-ray image receptors, including storage phosphor systems .29 5.13 Spatial resolution 30 5.14 LOW CONTRAST DETECTABILITY33 5.15 Entrance surface AIR
23、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 compliance 36 Annex A (informative) TEST DEVICES and arrangements for testing the automatic exposure control system with a digital X-RAY IM
24、AGE 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 screen-film X-ray image receptor .43 Annex D (informative) Test methods for storage phosphor system .45 BS EN 61223-3-2:2008 3 Licen
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS EN 61223 2008
链接地址:https://www.31doc.com/p-3743742.html