IEC 61675-2-2015 Radionuclide imaging devices - Characteristics and test conditions - Part 2 Gamma cameras for planar wholebody and SPECT imaging《放射性核素影像装置 性能和试验条件 第2部分 用于平面 全身和SPECT成像的伽马相机》.pdf

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1、 IEC 61675-2 Edition 2.0 2015-08 INTERNATIONAL STANDARD NORME INTERNATIONALE Radionuclide imaging devices Characteristics and test conditions Part 2: Gamma cameras for planar, wholebody, and SPECT imaging Dispositifs dimagerie par radionuclides Caractristiques et conditions dessai Partie 2: Gamma-ca

2、mras pour limagerie planaire, limagerie du corps entier et limagerie SPECT IEC 61675-2:2015-08(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2015 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

3、 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 or have an enquiry about obtaining additional rights to thi

4、s 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 utilise sous quelque forme que ce soit et par aucun procd, lectr

5、onique 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 supplmentaires sur cette publication, utilisez les coordonnes ci-aprs o

6、u 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 Electrotechnical Commission (IEC) is the leading global organization t

7、hat 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, a corrigenda or an amendment might

8、 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 documents. Available for PC, Mac OS, Android Tablets and iPad. IEC p

9、ublications 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 publications. IEC Just Published - webstore.iec.ch/justpublished Stay

10、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 and electrical terms containing more than 30 000 terms and definitions

11、 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 entries in English and French extracted from the Terms and Definitions

12、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 publication or need further assistance, please contact the Customer

13、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 et aux technologies apparentes. A propos des publications IEC Le cont

14、enu 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 pour consulter tous les renseignements bibliographiques sur les Norm

15、es 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 de trouver des publications IEC en utilisant diffrents critres (numro

16、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. Just Published dtaille les nouvelles publications parues. Disponible en

17、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 que les termes quivalents dans 15 langues additionnelles. Egalement a

18、ppel 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 publications IEC parues depuis 2002. Plus certaines entres antrieures

19、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 61675-2 Edition 2.0 2015-08 INTERNATIONAL STANDARD NORME INTERNATIONALE

20、Radionuclide imaging devices Characteristics and test conditions Part 2: Gamma cameras for planar, wholebody, and SPECT imaging Dispositifs dimagerie par radionuclides Caractristiques et conditions dessai Partie 2: Gamma-camras pour limagerie planaire, limagerie du corps entier et limagerie SPECT IN

21、TERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.50 ISBN 978-2-8322-2819-7 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this public

22、ation from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 IEC 61675-2:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope 7 2 Normative references . 7 3 Terms and definitions. 7 4 Test methods . 15 4.1 General .

23、15 4.2 Planar imaging 16 4.2.1 SYSTEM SENSITIVITY 16 4.2.2 SPATIAL RESOLUTION . 18 4.2.3 SPATIAL NON-LINEARITY 24 4.2.4 NON-UNIFORMITY OF RESPONSE 25 4.2.5 INTRINSIC ENERGY RESOLUTION . 28 4.2.6 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION 29 4.2.7 COUNT RATE performance . 31 4.2.8 Shield leakage

24、test . 33 4.3 Wholebody imaging . 33 4.3.1 Scanning constancy . 33 4.3.2 SPATIAL RESOLUTION without scatter 36 4.4 Tomographic imaging (SPECT) . 37 4.4.1 Test of PROJECTION geometry . 37 4.4.2 Measurement of SPECT SYSTEM SENSITIVITY . 41 4.4.3 Scatter measurement . 44 4.4.4 SPECT SYSTEM SPATIAL RESO

25、LUTION . 48 4.4.5 Tomographic image quality . 50 5 Accompanying documents 57 5.1 General . 57 5.2 General parameters for GAMMA CAMERAS 58 5.2.1 COLLIMATORS 58 5.2.2 Shield leakage values 58 5.2.3 Pre-set PULSE AMPLITUDE ANALYSER WINDOWS 58 5.2.4 INTRINSIC ENERGY RESOLUTION . 58 5.2.5 COLLIMATOR depe

26、ndent quantities . 58 5.2.6 COUNT RATE CHARACTERISTICS . 58 5.2.7 Measured COUNT RATE that is 80 % of the corresponding TRUE COUNT RATE 58 5.2.8 Dimensions of the DETECTOR FIELD OF VIEW . 58 5.2.9 Non-uniformity characteristics 58 5.2.10 INTRINSIC SPATIAL RESOLUTION (FWHM and EW) of the DETECTOR HEA

27、D without COLLIMATOR 58 5.2.11 INTRINSIC SPATIAL NON-LINEARITY . 58 5.2.12 Intrinsic MULTIPLE WINDOW SPATIAL REGISTRATION 59 5.3 GAMMA CAMERA based wholebody imaging system . 59 5.3.1 Scanning constancy . 59 5.3.2 SPATIAL RESOLUTION . 59 5.4 SPECT 59 IEC 61675-2:2015 IEC 2015 3 5.4.1 Calibration mea

28、surements of COR . 59 5.4.2 Measurement of head tilt 59 5.4.3 Measurement of COLLIMATOR hole misalignment 59 5.4.4 TRANSVERSE RESOLUTION (radial and tangential) 59 5.4.5 AXIAL RESOLUTION . 59 5.4.6 Axial PIXEL size 59 5.4.7 Transaxial PIXEL size 59 5.4.8 DETECTOR POSITIONING TIME 59 5.4.9 NORMALIZED

29、 VOLUME SENSITIVITY . 59 5.4.10 SCATTER FRACTIONS SF iand SF 59 5.4.11 Scan set up and phantom ACTIVITY concentration 59 5.4.12 Image quality . 59 5.4.13 Accuracy of ATTENUATION correction and scatter correction . 59 5.4.14 Accuracy of SPECT and CT image registration . 59 Index of defined terms . 60

30、 Bibliography 62 Figure 1 Geometry of PROJECTIONS . 9 Figure 2 Cylindrical phantom 14 Figure 3 Cuvette . 17 Figure 4 Slit phantom . 19 Figure 5 Source arrangement for intrinsic measurements . 20 Figure 6 Calculation of FWHM 22 Figure 7 Evaluation of equivalent width (EW) 23 Figure 8 Uniform source .

31、 26 Figure 9 Small shielded liquid source 29 Figure 10 Source positions for scanning constancy for wholebody imaging 35 Figure 11 Cylindrical phantom 43 Figure 12 Phantom insert with holders for the scatter source 45 Figure 13 Evaluation of scatter fraction . 47 Figure 14 Reporting transverse resolu

32、tion . 49 Figure 15 Cross-section of body phantom . 51 Figure 16 Phantom insert with hollow spheres 52 Figure 17 Placement of ROIs in the phantom background . 55 Table 1 RADIONUCLIDES and ENERGY WINDOWS to be used for performance measurements 16 4 IEC 61675-2:2015 IEC 2015 INTERNATIONAL ELECTROTECHN

33、ICAL COMMISSION _ RADIONUCLIDE IMAGING DEVICES CHARACTERISTICS AND TEST CONDITIONS Part 2: Gamma cameras for planar, wholebody, and SPECT imaging FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical c

34、ommittees (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 to other activities, IEC publishes International Standards, Technical Specifications, Techn

35、ical 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 the subject dealt with may participate in this preparatory work. International, governmen

36、tal 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 conditions determined by agreement between the two organizations. 2) The formal decisions or a

37、greements 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 National Committees. 3) IEC Publications have the form of recommendations for international u

38、se 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 way in which they are used or for any misinterpretation by any end user. 4) In order to pro

39、mote 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 IEC Publication and the corresponding national or regional publication shall be clearly indi

40、cated 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. IEC is not responsible for any services carried out by independent certification bodies. 6

41、) 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 Committees for any personal injury, property dama

42、ge 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 drawn to the Normative references cited in this publ

43、ication. 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 be held responsible for identifying any or all s

44、uch patent rights. International Standard IEC 61675-2 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This second edition of IEC 61675-2 cancels and replaces the firs

45、t edition published in 1998 and its Amendment 1 published in 2004, as well as IEC 60789:2005, IEC 60789:2005/COR1:2009, and IEC 61675-3:1998. It has been reformatted, updated, and partly aligned with NEMA NU 1- 2007. Due to the lack of market share of SPECT-systems operated in coincidence mode all s

46、uch tests have been removed. IEC 61675-2:2015 IEC 2015 5 The text of this standard is based on the following documents: FDIS Report on voting 62C/616/FDIS 62C/623/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. T

47、his publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: TERMS DEFINED IN CLAUSE 2 OF THIS STANDARD OR LISTED IN THE INDEX OF DEFINED TERMS: SMALL CAPITALS. The requirements are followed by specifications for the releva

48、nt tests. Annex A is for information only. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be

49、reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 IEC 61675-2:2015 IEC 2015 INTRODUCTION The test methods specified in this part of IEC 61675 have been selected to reflect as much as possible the clinical use of GAMMA CAMERAS for planar imaging, PLANAR WHOLEBODY IMAGING EQUIPMENT, and SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT). It is intended that the test

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