EN 62220-1-1-2015 en Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1 Determination of the detective quantum efficiency - Detectors used i.pdf

1、BSI Standards PublicationMedical electrical equipment Characteristics of digital x-rayimaging devicesPart 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imagingBS EN 62220-1-1:2015National forewordThis British Standard is the UK implementation of EN 62220-1-1:2

2、015. It isidentical to IEC 62220-1-1:2015. It supersedes BS EN 62220-1:2004, whichwill be withdrawn on 16 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee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 lis

3、t of organizations represented on this committee can be obtained onrequest to its 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 Lim

4、ited 2015ISBN 978 0 580 75550 7ICS 11.040.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2015.Amendments/corrigenda issued since publicationDate Text af

5、fectedBRITISH STANDARDBS EN 62220-1-1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 62220-1-1 June 2015 ICS 11.040.50 Supersedes EN 62220-1:2004 English Version Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1-1: Determination of the detective quant

6、um efficiency - Detectors used in radiographic imaging (IEC 62220-1-1:2015) Appareils lectromdicaux - Caractristiques des appareils dimagerie rayonnements x - Partie 1-1: Dtermination de lefficacit quantique de dtection - Dtecteurs utiliss en imagerie radiographique (IEC 62220-1-1:2015) Medizinische

7、 elektrische Gerte - Merkmale digitaler Rntgenbildgerte - Teil 1-1: Bestimmung der detektiven Quanten-Ausbeute - Bildempfnger fr Rntgenbildgebung (IEC 62220-1-1:2015) This European Standard was approved by CENELEC on 2015-04-16. CENELEC members are bound to comply with the CEN/CENELEC Internal Regul

8、ations 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 Centre or to any CENELEC m

9、ember. 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 status as the official vers

10、ions. 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, Luxembourg, Malta, th

11、e Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Manage

12、ment 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 62220-1-1:2015 E BS EN 62220-1-1:2015EN 62220-1-1:2015 2 Foreword The text of document 62B/968/FDIS, future edition 2 of IEC 62220-1

13、-1, 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 approved by CENELEC as EN 62220-1-1:2015. The following dates are fixed: latest date by which the document has to be implemented at nat

14、ional level by publication of an identical national standard or by endorsement (dop) 2016-01-16 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-16 This document supersedes EN 62220-1:2004. Attention is drawn to the possibility that some of

15、 the elements of this 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

16、 supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 62220-1-1:2015 was approved by CENELEC as a European Standard without any

17、 modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 62220-1-3:2008 NOTE Harmonized as EN 62220-1-3:2008. IEC 62220-1-2:2007 NOTE Harmonized as EN 62220-1-2:2007. IEC 61262-5:1994 NOTE Harmonized as EN 61262-5:1994. IEC 60601

18、-2-54 NOTE Harmonized as EN 60601-2-54. BS EN 62220-1-1:2015EN 62220-1-1:2015 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 ind

19、ispensable for its application. For dated references, 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

20、relevant EN/HD applies. NOTE 2 Up-to-date information 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 60336 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of

21、 focal spots EN 60336 - IEC 61267 2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics EN 61267 2006 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 62220-1-1:2015EN 62220-1-1:2015 4 Annex ZZ (informative)

22、 Coverage of Essential Requirements 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 EC Direc

23、tive 93/42/EEC of 14 June 1993 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 EC Directives can be applied to the products falling within the scope

24、of this standard. BS EN 62220-1-1:2015 2 IEC 62220-1-1:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope 7 2 Normative references 7 3 Terms and definitions 8 4 Requirements 10 Operating conditions . 10 4.1X-RAY EQUIPMENT . 10 4.2RADIATION QUALITY . 10 4.3TEST DEVICE 11 4.4Geometry 12 4.5I

25、RRADIATION conditions 14 4.64.6.1 General conditions . 14 4.6.2 AIR KERMA measurement 15 4.6.3 Avoidance of LAG EFFECTS 16 4.6.4 IRRADIATION to obtain the CONVERSION FUNCTION. 16 4.6.5 IRRADIATION for determination of the NOISE POWER SPECTRUM 16 4.6.6 IRRADIATION for determination of the MODULATION

26、TRANSFER FUNCTION 17 4.6.7 Overview of all necessary IRRADIATIONS . 18 5 Corrections of RAW DATA 18 6 Determination of the DETECTIVE QUANTUM EFFICIENCY 19 Definition and formula of DQE(u,v) 19 6.1Parameters to be used for evaluation 19 6.2Determination of different parameters from the images . 20 6.

27、36.3.1 Linearization of data 20 6.3.2 The NOISE POWER SPECTRUM (NPS) . 20 6.3.3 Determination of the MODULATION TRANSFER FUNCTION (MTF) 22 7 Format of conformance statement . 24 8 Accuracy . 25 Annex A (normative) Determination of LAG EFFECTS 26 A.1 Overview. 26 A.2 Estimation of LAG EFFECTS (defaul

28、t method) 26 A.3 Estimation of LAG EFFECTS, alternative method (only if no LAG EFFECT or ghosting compensation is applied) 26 General . 26 A.3.1Test of additive LAG EFFECTS 27 A.3.2Test of multiplicative LAG EFFECTS 29 A.3.3Determination of the minimum time between consecutive images 31 A.3.4Annex B

29、 (informative) Calculation of the input NOISE POWER SPECTRUM. 32 Bibliography 33 Index of defined terms used in this particular standard 36 Figure 1 TEST DEVICE for the determination of the MODULATION TRANSFER FUNCTION and the magnitude of LAG EFFECTS 12 BS EN 62220-1-1:2015IEC 62220-1-1:2015 IEC 20

30、15 3 Figure 2 Geometry for exposing the DIGITAL X-RAY IMAGING DEVICE behind the TEST DEVICE in order to determine LAG EFFECTS and the MODULATION TRANSFER FUNCTION 14 Figure 3 Position of the TEST DEVICE for the determination of the MODULATION TRANSFER FUNCTION . 17 Figure 4 Geometric arrangement of

31、the ROIs for NPS calculation 21 Figure 5 Representation of the image acquired for the determination of the MTF . 23 Figure A.1 Definition of the ROIs for the test of additive LAG EFFECTS . 28 Figure A.2 Procedure flow diagram for the test of additive LAG EFFECTS . 28 Figure A.3 Definition of the ROI

32、s for the test of the multiplicative LAG EFFECTS . 30 Figure A.4 Procedure flow diagram for the test of multiplicative LAG EFFECTS . 30 Table 1 RADIATION QUALITY (IEC 61267:2005) for the determination of DETECTIVE QUANTUM EFFICIENCY and corresponding parameters . 11 Table 2 Necessary IRRADIATIONS 18

33、 Table 3 Parameters mandatory for the application of this standard 20 BS EN 62220-1-1:2015 4 IEC 62220-1-1:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES Part 1-1: Determination of the detective quantum efficien

34、cy Detectors used in radiographic imaging 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 q

35、uestions 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 Publicat

36、ion(s)”). 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 c

37、ollaborates 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 opini

38、on on 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 en

39、sure that 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

40、to the 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 certificat

41、ion bodies 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 at

42、tach 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 damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fe

43、es) 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 publication. Use of the referenced publications is indispensable for the correct application of this publicat

44、ion. 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 such patent rights. International Standard IEC 62220-1-1 has been prepared by subcommittee 62B: Diagnostic

45、 imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This first edition of IEC 62220-1-1 cancels and replaces IEC 62220-1:2003. It constitutes a technical revision of IEC 62220-1:2003 and assures a better alignment with the other parts of the IEC 62220 series.

46、 The main changes are as follows: necessary modifications have been applied as a consequence of taking into account IEC 61267:2005. This influences HVL values and SNRin2; the method for the determination of LAG EFFECTS now considers lag and ghosting compensation; as part of the MTF determination, th

47、e method of obtaining the final averaged MTF has been restricted (only averaging of the ESF is allowed); BS EN 62220-1-1:2015IEC 62220-1-1:2015 IEC 2015 5 a description of (optionally) obtaining the diagonal (45) MTF and NPS has been added. The text of this standard is based on the following documen

48、ts: FDIS Report on voting 62B/968/FDIS 62B/974/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. A list of all parts of the IEC 6

49、2220 series, published under the general title Medical electrical equipment Characteristics of digital X-ray imaging devices, can be found on the IEC website. In this standard, terms printed in SMALL CAPITALS are used as defined in IEC 60788, in Clause 3 of this standard or in other IEC publications referenced in the Index of defined terms. Where a defined term is used as a qualifier in another defined or undefined term, it is not printed in SMALL CAPITALS, unless the c