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IEC 62220-1-1-2015 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1 Determination of the detective quantum efficiency .pdf

1、 IEC 62220-1-1 Edition 1.0 2015-03 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging Appareils lectromdicaux Caractristiques des

2、dispositifs dimagerie rayonnement X Partie 1-1: Dtermination de lefficacit quantique de dtection Dtecteurs utiliss en imagerie radiographique IEC 62220-1-1:2015-03(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2015 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified,

3、no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC

4、copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduit

5、e ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de lIEC ou du Comit national de lIEC du pays du demandeur. Si vous avez des questions sur le copyright de lIEC ou si vous dsirez obtenir des droits su

6、pplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de lIEC de votre pays de rsidence. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International E

7、lectrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure

8、 that you have the latest edition, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other

9、 documents. Available for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn p

10、ublications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic a

11、nd electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in 15 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary More than 60 000 electrotechnical terminology en

12、tries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this

13、 publication or need further assistance, please contact the Customer Service Centre: csciec.ch. A propos de lIEC La Commission Electrotechnique Internationale (IEC) est la premire organisation mondiale qui labore et publie des Normes internationales pour tout ce qui a trait llectricit, llectronique

14、et aux technologies apparentes. A propos des publications IEC Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue IEC - webstore.iec.ch/catalogue Application autonome

15、 pour consulter tous les renseignements bibliographiques sur les Normes internationales, Spcifications techniques, Rapports techniques et autres documents de lIEC. Disponible pour PC, Mac OS, tablettes Android et iPad. Recherche de publications IEC - www.iec.ch/searchpub La recherche avance permet d

16、e trouver des publications IEC en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publications remplaces ou retires. IEC Just Published - webstore.iec.ch/justpublished Restez inform sur les nouvelles publications IEC. Jus

17、t Published dtaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en anglais et en franais, ainsi

18、que les termes quivalents dans 15 langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary Plus de 60 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des p

19、ublications IEC parues depuis 2002. Plus certaines entres antrieures extraites des publications des CE 37, 77, 86 et CISPR de lIEC. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 622

20、20-1-1 Edition 1.0 2015-03 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging Appareils lectromdicaux Caractristiques des disposit

21、ifs dimagerie rayonnement X Partie 1-1: Dtermination de lefficacit quantique de dtection Dtecteurs utiliss en imagerie radiographique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.50 ISBN 978-2-8322-2389-5 Registered trademark of the International El

22、ectrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 IEC 62220-1-1:2015 IEC 2015

23、 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 4.5IRRADIATION conditions 14 4.6 4.6.1 General conditions . 14 4.6.2 AIR

24、 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 TRANSFER FUNCTION 17 4.6.7 Overview of all necessary IRRADIATIONS .

25、 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 6.3 6.3.1 Linearization of data 20 6.3.2 The NOISE POWER SPECTRUM (NP

26、S) . 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 (default method) 26 A.3 Estimation of LAG EFFECTS, alternative method (on

27、ly 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.3.4 Annex B (informative) Calculation of the input NOISE POWER SPECTRUM. 32

28、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 IEC 62220-1-1:2015 IEC 2015 3 Figure 2 Geometry for exposing the DIGITAL X-RAY IMAGING DEVICE behind the TEST

29、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 the ROIs for NPS calculation 21 Figure 5 Representation of the image acquired for the

30、 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 ROIs for the test of the multiplicative LAG EFFECTS . 30 Figure A.4 Procedure flow diagr

31、am 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 Table 3 Parameters mandatory for the application of this standard 20 4 IEC 62220-1-1

32、2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging FOREWORD 1) The International Electrotechnical Commission (IEC)

33、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 end and in addition t

34、o other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in

35、 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 collaborates closely with the International Organization for Standardization (ISO) in accordance with cond

36、itions 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 the relevant subjects since each technical committee has representation from all interested IEC Nat

37、ional 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 that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the w

38、ay 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 maximum extent possible in their national and regional publications. Any divergence between any IE

39、C 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 bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity.

40、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 to IEC or its directors, employees, servants or agents including individual experts and members of i

41、ts 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) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any ot

42、her 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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be th

43、e 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 imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This first e

44、dition 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. The main changes are as follows: necessary modifications have been applied as a consequence of taking in

45、to account IEC 61267:2005. This influences HVL values and SNR in 2; the method for the determination of LAG EFFECTS now considers lag and ghosting compensation; as part of the MTF determination, the method of obtaining the final averaged MTF has been restricted (only averaging of the ESF is allowed)

46、 IEC 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 documents: FDIS Report on voting 62B/968/FDIS 62B/974/RVD Full information on the voting for the approval of this standard can be

47、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 62220 series, published under the general title Medical electrical equipment Characteristics of digital X-ray imaging device

48、s, 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

49、 it is not printed in SMALL CAPITALS, unless the concept thus qualified is defined or recognized as a “derived term without definition”. NOTE Attention is drawn to the fact that, in cases where the concept addressed is not strongly confined to the definition given in one of the publications listed above, a corresponding term is printed in lower-case letters. In this standard, certai

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