IEC-61675-1-2008.pdf

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1、 IEC 61675-1 Edition 1.1 2008-06 INTERNATIONAL STANDARD Radionuclide imaging devices Characteristics and test conditions Part 1: Positron emission tomographs IEC 61675-1:1998+A1:2008(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherw

2、ise specified, 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 quest

3、ions about IEC 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. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.

4、ch About the IEC The International Electrotechnical 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

5、 review by the IEC. Please make sure that you have the latest edition, 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,)

6、. It also gives information on projects, withdrawn and replaced publications. ? 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

7、.electropedia.org The worlds leading online dictionary of electronic and electrical 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 Cen

8、tre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this 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 IEC 61675-1 Edition 1.1 2008-06 INTERNATIONAL STANDARD Radi

9、onuclide imaging devices Characteristics and test conditions Part 1: Positron emission tomographs INTERNATIONAL ELECTROTECHNICAL COMMISSION CH ICS 11.040.50 PRICE CODE ISBN 2-8318-9780-7 2 61675-1 IEC:1998+A1:2008(E) CONTENTS FOREWORD.3 INTRODUCTION (to amendment 1).5 1 General 6 1.1 Scope and objec

10、t.6 1.2 Normative reference 6 2 Terminology and definitions 6 3 Test methods12 3.1 SPATIAL RESOLUTION.12 3.2 RECOVERY COEFFICIENT15 3.3 Tomographic sensitivity .16 3.4 Uniformity18 3.5 COUNT RATE CHARACTERISTIC18 3.6 Scatter measurement 21 3.7 ATTENUATION correction .23 4 ACCOMPANYING DOCUMENTS.25 A

11、nnex A (informative) Index of defined terms 38 Figure 1 Cylindrical head phantom28 Figure 2 Cross-section of body phantom.29 Figure 3 Arm phantom29 Figure 4 Phantom insert with hollow spheres 30 Figure 5 Phantom insert with holders for the scatter source 31 Figure 6 Phantom insert for the evaluation

12、 of ATTENUATION correction .32 Figure 7 Phantom configuration for COUNT RATE measurements according to 3.5.3.1.2 (cardiac imaging) 33 Figure 8 Scheme of the evaluation of COUNT LOSS correction.33 Figure 9 Evaluation of ATTENUATION correction34 Figure 10 Evaluation of SCATTER FRACTION34 Figure 11 Eva

13、luation of FWHM.35 Figure 12 Evaluation of EQUIVALENT WIDTH (EW).36 Figure 13 Phantom position and location of screws for abdominal imaging (see 3.5.3.1.3).37 Table 1 RADIONUCLIDES to be used in performance measurements27 61675-1 IEC:1998+A1:2008(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ RADI

14、ONUCLIDE IMAGING DEVICES CHARACTERISTICS AND TEST CONDITIONS Part 1: Positron emission tomographs FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object

15、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, Technical Reports, Publicly Available Specifications

16、(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, governmental and non- governmental organizations liaising

17、 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 agreements of IEC on technical matters express, a

18、s 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 use and are accepted by IEC National Committees i

19、n 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 promote international uniformity, IEC National Comm

20、ittees 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 indicated in the latter. 5) IEC provides no marking

21、procedure to indicate its approval and cannot be rendered responsible for any equipment declared 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

22、 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) and expenses arising out of the publication, use

23、 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) Attention is drawn to the possibility that s

24、ome 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 61675-1 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosim

25、etry, of IEC technical committee 62: Electrical equipment in medical practice. This consolidated version of IEC 61675-1 consists of the first edition (1998) documents 62C/205/FDIS and 62C/214/RVD and its amendment 1 (2008) documents 62C/419/CDV and 62C/432/RVC. The technical content is therefore ide

26、ntical to the base edition and its amendment and has been prepared for user convenience. It bears the edition number 1.1. A vertical line in the margin shows where the base publication has been modified by amendment 1. 4 61675-1 IEC:1998+A1:2008(E) In this standard, the following print types are use

27、d: TERMS DEFINED IN CLAUSE 2 OF THIS STANDARD OR LISTED IN ANNEX A: SMALL CAPITALS. The requirements are followed by specifications for the relevant tests. Annex A is for information only. The committee has decided that the contents of the base publication and its amendments will remain unchanged un

28、til 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. A bilingual version of this standard may be issued at

29、a later date. 61675-1 IEC:1998+A1:2008(E) 5 INTRODUCTION (to amendment 1) Further developments of POSITRON EMISSION TOMOGRAPHS allow most of the tomographs to be operated in fully 3D acquisition mode. To comply with this trend, this amendment describes test conditions in accordance with the acquisit

30、ion characteristic. It is the intention to simulate 3D imaging without introducing new phantoms or new acquisition or processing protocols. The test does simulate more realistically count rate characteristics for whole body imaging. Measurement of SCATTER FRACTION is not intended with this test. Cer

31、tain parts of the standard are amended as stated below. 6 61675-1 IEC:1998+A1:2008(E) RADIONUCLIDE IMAGING DEVICES CHARACTERISTICS AND TEST CONDITIONS Part 1: Positron emission tomographs 1 General 1.1 Scope and object This part of IEC 61675 specifies terminology and test methods for declaring the c

32、haracteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDEs by COINCIDENCE DETECTION. The test methods specified in this part of IEC 61675 have been selected to reflect as much as possible the clinical use of POSIT

33、RON EMISSION TOMOGRAPHS. It is intended that the test methods be carried out by manufacturers, thereby enabling them to declare the characteristics of POSITRON EMISSION TOMOGRAPHS. So, the specifications given in the ACCOMPANYING DOCUMENTS shall be in accordance with this standard. This standard doe

34、s not imply which tests will be performed by the manufacturer on an individual tomograph. No test has been specified to characterize the uniformity of reconstructed images, because all methods known so far will mostly reflect the noise in the image. 1.2 Normative reference The following normative do

35、cument contains provisions which, through reference in this text, constitute provisions of this part of IEC 61675. At the time of publication, the edition indicated was valid. All normative documents are subject to revision, and parties to agreements based on this part of IEC 61675 are encouraged to

36、 investigate the possibility of applying the most recent edition of the normative document indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC 60788:1984, Medical radiology Terminology 2 Terminology and definitions For the purpose of this part o

37、f IEC 61675, the definitions given in IEC 60788 (see annex A) and the following definitions apply. Defined terms are printed in small capitals. 2.1 TOMOGRAPHY (see annex A) 2.1.1 TRANSVERSE TOMOGRAPHY in TRANSVERSE TOMOGRAPHY the three-dimensional object is sliced by physical methods, for example co

38、llimation, into a stack of OBJECT SLICES, which are considered as being two- dimensional and independent from each other. The transverse IMAGE PLANES are perpendicular to the SYSTEM AXIS. 61675-1 IEC:1998+A1:2008(E) 7 2.1.2 EMISSION COMPUTED TOMOGRAPHY (ECT) imaging method for the representation of

39、the spatial distribution of incorporated RADIONUCLIDEs in selected two-dimensional slices through the object 2.1.2.1 PROJECTION transformation of a three-dimensional object into its two-dimensional image or of a two- dimensional object into its one-dimensional image, by integrating the physical prop

40、erty which determines the image along the direction of the PROJECTION BEAM NOTE This process is mathematically described by line integrals in the direction of projection (along the LINE OF RESPONSE) and called Radon-transform. 2.1.2.2 PROJECTION BEAM determines the smallest possible volume in which

41、the physical property which determines the image is integrated during the measurement process. Its shape is limited by SPATIAL RESOLUTION in all three dimensions. NOTE The PROJECTION BEAM mostly has the shape of a long thin cylinder or cone. In POSITRON EMISSION TOMOGRAPHY, it is the sensitive volum

42、e between two detector elements operated in coincidence. 2.1.2.3 PROJECTION ANGLE angle at which the PROJECTION is measured or acquired 2.1.2.4 SINOGRAM two-dimensional display of all one-dimensional PROJECTIONs of an OBJECT SLICE, as a function of the PROJECTION ANGLE. The PROJECTION ANGLE is displ

43、ayed on the ordinate, the linear PROJECTION coordinate is displayed on the abscissa. 2.1.2.5 OBJECT SLICE slice in the object. The physical property of this slice, that determines the measured information, is displayed in the tomographic image. 2.1.2.6 IMAGE PLANE a plane assigned to a plane in the

44、OBJECT SLICE NOTE Usually the IMAGE PLANE is the midplane of the corresponding OBJECT SLICE. 2.1.2.7 SYSTEM AXIS axis of symmetry, characterized by geometrical and physical properties of the arrangement of the system NOTE For a circular POSITRON EMISSION TOMOGRAPH, the SYSTEM AXIS is the axis throug

45、h the centre of the detector ring. For tomographs with rotating detectors it is the axis of rotation. 2.1.2.8 TOMOGRAPHIC VOLUME juxtaposition of all volume elements which contribute to the measured PROJECTIONs for all PROJECTION ANGLES -,-,- 8 61675-1 IEC:1998+A1:2008(E) 2.1.2.8.1 TRANSVERSE FIELD

46、OF VIEW dimensions of a slice through the TOMOGRAPHIC VOLUME, perpendicular to the SYSTEM AXIS. For a circular TRANSVERSE FIELD OF VIEW, it is described by its diameter NOTE For non-cylindrical TOMOGRAPHIC VOLUMES the TRANSVERSE FIELD OF VIEW may depend on the axial position of the slice. 2.1.2.8.2

47、AXIAL FIELD OF VIEW dimensions of a slice through the TOMOGRAPHIC VOLUME, parallel to and including the SYSTEM AXIS. In practice, it is specified only by its axial dimension, given by the distance between the centre of the outmost defined IMAGE PLANEs plus the average of the measured AXIAL SLICE WID

48、TH 2.1.2.8.3 TOTAL FIELD OF VIEW dimensions (three-dimensional) of the TOMOGRAPHIC VOLUME 2.1.3 POSITRON EMISSION TOMOGRAPHY (PET) EMISSION COMPUTED TOMOGRAPHY utilizing the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION 2.1.3.1 POSITRON EMISSION TOMOGRAPH tomogra

49、phic device, which detects the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION 2.1.3.2 ANNIHILATION RADIATION ionizing radiation that is produced when a particle and its antiparticle interact and cease to exist 2.1.3.3 COINCIDENCE DETECTION a method which checks whether two opposing detectors have detected one photon each simultaneously. By this method the two photons are concatenated into

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