BS EN 60627-2015 Diagnostic X-ray imaging equipment Characteristics of general purpose and mammographic anti-scatter grids《X射线诊断成像设备 通用及胸部肿瘤防散射网格的特性》.pdf

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1、BSI Standards PublicationDiagnostic X-ray imaging equipment Characteristics of general purpose and mammographic anti-scatter gridsBS EN 60627:2015National forewordThis British Standard is the UK implementation of EN 60627:2015. It is identical to IEC 60627:2013. It supersedes BS EN 60627:2001, which

2、 will bewithdrawn on 14 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its

3、secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 71526 6ICS 11.040.50Compliance with a British Standard can

4、not confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60627:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE N

5、ORMEN 60627 May 2015 ICS 11.040.50 Supersedes EN 60627:2001 English Version Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2013) quipements de diagnostic par imagerie rayonnement X -Caractristiques des grilles antidiffusantes du

6、sage gnral et de Mammographie (IEC 60627:2013) Bildgebende Gerte fr die Rntgendiagnostik - Kenngren von Streustrahlenrastern fr die allgemeineAnwendung und fr die Mammographie (IEC 60627:2013) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the

7、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 C

8、entre 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 st

9、atus as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania

10、, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Norm

11、ung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60627:2015 E EN 60627:2015 2 Foreword The text of document 62B/914/FDIS, future edition 3 of IEC 60627, prepar

12、ed 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 60627:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by pub

13、lication of an identical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60627:2001. Attention is drawn to the possibility that some of the elements of thi

14、s document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential

15、requirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60627:2013 was approved by CENELEC as a European Standard without any modification. B

16、S EN 60627:2015EN 60627:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referen

17、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date informa

18、tion 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 60601-1 +A1 2005 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March +A1

19、 +A1/AC +A12 2006 2010 2013 2014 2014 IEC 60601-1-3 +A1 2008 2013 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March +A1 +A1/AC 2008 2010 2013 20

20、14 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 61267 2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics EN 61267 2006 BS EN 60627:2015EN 60627:2015 4 Annex ZZ (informative) Coverage of Essential Requir

21、ements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 199

22、3 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60627

23、:2015 2 60627 IEC:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 7 1 Scope . 8 2 Normative references . 8 3 Terms and definitions . 8 3.1 Grid definitions 9 3.2 Geometric characteristics 10 3.3 Physical characteristics . 10 3.4 Other terms . 11 4 Structure of ANTI-SCATTER GRIDS . 12 5 Measurement and det

24、ermination of physical characteristics 12 5.1 Method and arrangement for measurement . 12 5.1.1 Determination of physical characteristics . 12 5.1.2 Instrumentation 13 5.1.3 Phantoms 14 5.1.4 Arrangements 14 5.1.5 Radiation conditions 16 5.1.6 Constancy of source 16 5.2 Physical characteristics . 16

25、 5.2.1 Measurements for the TRANSMISSION OF PRIMARY RADIATION (Tp). 16 5.2.2 Measurements for the TRANSMISSION OF SCATTERED RADIATION (Ts) 16 5.2.3 Measurements for the TRANSMISSION OF TOTAL RADIATION (Tt) . 17 5.2.4 Calculation of the GRID SELECTIVITY () 17 5.2.5 Calculation of the CONTRAST IMPROVE

26、MENT RATIO (K) 17 5.2.6 Calculation of the GRID EXPOSURE FACTOR (B) . 17 5.2.7 Calculation of the IMAGE IMPROVEMENT FACTOR (Q) . 17 5.2.8 Accuracy of measurements 17 6 Requirements for ANTI-SCATTER GRIDS . 18 6.1 Manufacturing tolerances 18 6.2 Determination of the APPLICATION LIMITS . 18 6.3 Accura

27、cy of characteristics 18 6.3.1 GRID SELECTIVITY . 18 6.3.2 CONTRAST IMPROVEMENT RATIO . 18 6.3.3 GRID EXPOSURE FACTOR 18 6.3.4 IMAGE IMPROVEMENT FACTOR . 19 6.4 Markings and ACCOMPANYING DOCUMENTS 19 6.4.1 Data in ACCOMPANYING DOCUMENTS 19 6.4.2 Mandatory markings and indications for LINEAR GRIDS 19

28、 6.4.3 Mandatory markings and indications for FOCUSED GRIDS . 19 6.4.4 Additional mandatory markings and indications . 19 6.4.5 Further requirements . 20 Annex A (normative) Calculation of the APPLICATION LIMITS . 27 Annex B (informative) Influence of scatter fraction on the physical characteristics

29、 . 30 Bibliography 32 Index of defined terms used in this standard . 33 BS EN 60627:201560627 IEC:2013 3 Figure 1 Structure of ANTI-SCATTER GRIDS . 21 Figure 2 RADIATION DETECTOR . 22 Figure 3 Measurement arrangement for general purpose ANTI-SCATTER GRIDS with NARROW-BEAM CONDITION (determination of

30、 the TRANSMISSION OF PRIMARY RADIATION) . 23 Figure 4 Measurement arrangement for general-purpose ANTI-SCATTER GRIDS with BROAD BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) 24 Figure 5 Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with NARROW-BEAM CONDITION

31、 (determination of the TRANSMISSION OF PRIMARY RADIATION) . 25 Figure 6 Measurement arrangement for MAMMOGRAPHIC ANTI-SCATTER GRIDS with BROAD BEAM CONDITION (determination of the TRANSMISSION OF SCATTERED RADIATION) 26 Figure B.1 Physical characteristics as function of scatter fraction: SELECTIVITY

32、 (dash-dotted line), CONTRAST IMPROVEMENT RATIO K (dotted line), GRID EXPOSURE FACTOR B (dashed line), and IMAGE IMPROVEMENT FACTOR Q (solid line) . 31 BS EN 60627:2015 4 60627 IEC:2013 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ DIAGNOSTIC X-RAY IMAGING EQUIPMENT Characteristics of general purpose

33、and mammographic anti-scatter grids FOREWORD 1) The International Electrotechnical 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 questio

34、ns concerning standardization in the electrical and electronic fields. To this end 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)

35、”). Their preparation is entrusted to technical committees; any IEC National Committee 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 collabo

36、rates closely with the International Organization for Standardization (ISO) in accordance 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

37、the relevant subjects since each technical committee has representation from all 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 t

38、hat the technical content of IEC Publications is accurate, IEC cannot be held responsible 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

39、 maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bo

40、dies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach t

41、o 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 damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) an

42、d 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 publication. Use of the referenced publications is indispensable for the correct application of this publication. 9

43、) 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 such patent rights. International Standard IEC 60627 has been prepared by subcommittee 62B: Diagnostic imaging e

44、quipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2001, and constitutes a technical revision. In this revision calcium tungstate phosphor FLUORESCENT SCREENS, which are no longer available, have

45、been replaced by gadolinium oxysulphide (GOS) FLUORESCENT SCREENS. Further, a new quality parameter is introduced: the IMAGE IMPROVEMENT FACTOR or Q-factor, which better describes the properties of the ANTI-SCATTER GRID, especially for digital detector applications. Further differences between this

46、third edition and the previous second edition are: some definitions have been modified and others added to improve clarity, harmonization or generality; BS EN 60627:201560627 IEC:2013 5 new instrumentation is prescribed for measurements of the TRANSMISSION OF PRIMARY RADIATION, the TRANSMISSION OF S

47、CATTERED RADIATION and the TRANSMISSION OF TOTAL RADIATION, because FLUORESCENT SCREENS made of calcium tungstate phosphors are outdated and are no longer available; the definition of the PHANTOM used for measurements of the TRANSMISSION OF PRIMARY RADIATION, the TRANSMISSION OF SCATTERED RADIATION

48、and the TRANSMISSION OF TOTAL RADIATION is modified and references to IEC 61267 are omitted; the RADIATION CONDITIONS used for the measurements have been adapted and are now the RQR and RQR-M conditions specified in IEC 61267:2005; tolerances are specified for the dimensions in the arrangements for

49、the measurements of the TRANSMISSION OF PRIMARY RADIATION, the TRANSMISSION OF SCATTERED RADIATION and the TRANSMISSION OF TOTAL RADIATION. The text of this standard is based on the following documents: FDIS Report on voting 62B/914/FDIS 62B/922/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 publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the foll