1、 IEC 62220-1-3 Edition 1.0 2008-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-3: Determination of the detective quantum efficiency Detectors used in dynamic imaging Appareils lectromdicaux Caractristiques des dispo
2、sitifs dimagerie numrique rayonnement X Partie 1-3: Dtermination de lefficacit quantique de dtection Dtecteurs utiliss en imagerie dynamique IEC 62220-1-3:2008 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of
3、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 copyright o
4、r 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 reproduite ni utilis
5、e sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplme
6、ntaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) i
7、s 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 that you have the latest edition,
8、 a corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publicat
9、ions. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and ele
10、ctrical terms containing more than 20 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this
11、 publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des norm
12、es internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut av
13、oir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications ret
14、ires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnair
15、e en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/websto
16、re/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 62220-1-3 Edition 1.0 2008-06 INTERNATIONAL STANDARD
17、 NORME INTERNATIONALE Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1-3: Determination of the detective quantum efficiency Detectors used in dynamic imaging Appareils lectromdicaux Caractristiques des dispositifs dimagerie numrique rayonnement X Partie 1-3: Dterm
18、ination de lefficacit quantique de dtection Dtecteurs utiliss en imagerie dynamique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.50 PRICE CODE CODE PRIX ISBN 2-8318-9826-9 2 62220-1-3 IEC:2008 CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.7 2 Normati
19、ve references .7 3 Terms and definitions .8 4 Requirements.10 4.1 Operating conditions .10 4.2 X-RAY EQUIPMENT.10 4.3 RADIATION QUALITY .10 4.4 TEST DEVICE.11 4.5 Geometry 12 4.6 IRRADIATION conditions 14 4.6.1 General conditions 14 4.6.2 AIR KERMA measurement 15 4.6.3 LAG EFFECTS.16 4.6.4 IRRADIATI
20、ON to obtain the CONVERSION FUNCTION 16 4.6.5 IRRADIATION for determination of the NOISE POWER SPECTRUM and LAG EFFECTS.16 4.6.6 IRRADIATION with TEST DEVICE in the RADIATION BEAM.17 4.6.7 Overview of all necessary IRRADIATIONS .18 5 Corrections of RAW DATA .18 6 Determination of the DETECTIVE QUANT
21、UM EFFICIENCY 19 6.1 Definition and formula of DQE(u,v).19 6.2 Parameters to be used for evaluation 19 6.3 Determination of different parameters from the images20 6.3.1 Linearization of data20 6.3.2 The LAG EFFECTS corrected NOISE POWER SPECTRUM (NPS) .20 6.3.3 Determination of the MODULATION TRANSF
22、ER FUNCTION (MTF)24 7 Format of conformance statement 24 8 Accuracy 25 Annex A (informative) Determination of LAG EFFECTS26 Annex B (informative) Calculation of the input NOISE POWER SPECTRUM 29 Bibliography30 Index of defined terms 32 Figure 1 TEST DEVICE .12 Figure 2 Geometry for exposing the DIGI
23、TAL X-RAY IMAGING DEVICE in order to determine the CONVERSION FUNCTION, the NOISE POWER SPECTRUM and the MODULATION TRANSFER FUNCTION behind the TEST DEVICE.14 Figure 3 Image acquisition sequence to determine the NOISE POWER SPECTRUM and LAG EFFECTS17 Figure 4 Geometric arrangement of the ROIs.21 Fi
24、gure A.1 Power spectral density of white noise s and correlated signal g (only positive frequencies are shown)27 62220-1-3 IEC:2008 3 Table 1 RADIATION QUALITY (IEC 61267:1994) for the determination of DETECTIVE QUANTUM EFFICIENCY and corresponding parameters .11 Table 2 Necessary IRRADIATIONS 18 Ta
25、ble 3 Parameters mandatory for the application of this standard 20 4 62220-1-3 IEC:2008 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES Part 1-3: Determination of the detective quantum efficiency Detectors used in dynamic imag
26、ing 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 questions concerning standardization in
27、 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)”). Their preparation is entrust
28、ed 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 collaborates closely with the Internat
29、ional 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 the relevant subjects since eac
30、h 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 that the technical content of IE
31、C 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 maximum extent possible in the
32、ir 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declar
33、ed to be in conformity with an IEC Publication. 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 its technical committees and IEC National
34、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 other IEC Publications. 8) Attention is dra
35、wn 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 the subject of patent rights. IEC shall not
36、 be held responsible for identifying any or all such patent rights. International Standard IEC 62220-1-3 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this standard is based on the following d
37、ocuments: FDIS Report on voting 62B/694/FDIS 62B/702/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. 62220-1-3 IEC:2008 5 A lis
38、t of all parts of the IEC 62220 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 o
39、r 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 concept thus qualified is defined or recognized as a “derived term without definition”. NOTE Attentio
40、n 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, certain terms that are not printed in SMALL CAPITALS have particular me
41、anings, as follows: “shall“ indicates a requirement that is mandatory for compliance; “should“ indicates a strong recommendation that is not mandatory for compliance; “may“ indicates a permitted manner of complying with a requirement or of avoiding the need to comply; “specific“ is used to indicate
42、definitive information stated in this standard or referenced in other standards, usually concerning particular operating conditions, test arrangements or values connected with compliance; “specified“ is used to indicate definitive information stated by the manufacturer in accompanying documents or i
43、n other documentation relating to the equipment under consideration, usually concerning its intended purposes, or the parameters or conditions associated with its use or with testing to determine compliance. The committee has decided that the contents of this publication will remain unchanged until
44、the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 6 62220-1-3 IEC:2008 INTRODUCTION DIGITAL X-RAY IMAGING DE
45、VICES are increasingly used in medical diagnosis and will widely replace conventional (analogue) imaging devices such as screen-film systems or analogue X- RAY IMAGE INTENSIFIER television systems in the future. It is necessary, therefore, to define parameters that describe the specific imaging prop
46、erties of these DIGITAL X-RAY IMAGING DEVICES and to standardize the measurement procedures employed. There is growing consensus in the scientific world that the DETECTIVE QUANTUM EFFICIENCY (DQE) is the most suitable parameter for describing the imaging performance of an X-ray imaging device. The D
47、QE describes the ability of the imaging device to preserve the signal-to- NOISE ratio from the radiation field to the resulting digital image data. Since in X-ray imaging, the NOISE in the radiation field is intimately coupled to the AIR KERMA level, DQE values can also be considered to describe the
48、 dose efficiency of a given DIGITAL X-RAY IMAGING DEVICE. NOTE 1 In spite of the fact that the DQE is widely used to describe the performance of imaging devices, the connection between this physical parameter and the decision performance of a human observer is not yet completely understood 1, 3. 1)N
49、OTE 2 IEC 61262-5 specifies a method to determine the DQE of X-RAY IMAGE INTENSIFIERS at nearly zero SPATIAL FREQUENCY. It focuses only on the electro-optical components of X-RAY IMAGE INTENSIFIERS, not on the imaging properties as this standard does. As a consequence, the output is measured as an optical quantity (luminance), and not as digital data. Moreover, IEC 612
