BS EN 61675-2-2015 Radionuclide imaging devices Characteristics and conditions Gamma cameras for planar wholebody and SPECT imaging《放射性核素成像设备 性能和条件 平面 全身和SPECT成像伽马照相机》.pdf

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1、BSI Standards PublicationRadionuclide imaging devices Characteristics and conditionsPart 2: Gamma cameras for planar, wholebody, and SPECT imagingBS EN 61675-2:2015National forewordThis British Standard is the UK implementation of EN 61675-2:2015. It isidentical to IEC 61675-2:2015. It supersedes BS

2、 EN 61675-2:1998, BS EN61675-3:1998 and BS EN 60789:2005, which will be withdrawn on 10September 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and

3、radiation dosimetry.A list 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.Publi

4、shed by BSI Standards Limited 2015ISBN 978 0 580 84670 0ICS 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 30 November 2015.Amendments/corrigenda issued

5、since publicationDate Text affectedBRITISH STANDARDBS EN 61675-2:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61675-2 November 2015 ICS 11.040.50 Supersedes EN 60789:2005, EN 61675-2:1998, EN 61675-3:1998 English Version Radionuclide imaging devices - Characteristics and conditions - Par

6、t 2: Gamma cameras for planar, wholebody, and SPECT imaging (IEC 61675-2:2015) Dispositifs dimagerie par radionuclides - Caractristiques et conditions dessai - Partie 2: Gamma-camras pour limagerie planaire, limagerie du corps entier et limagerie SPECT (IEC 61675-2:2015) Bildgebende Systeme in der N

7、uklearmedizin - Merkmale und Prfbedingungen - Teil 2: Gammakameras fr planare Bildgebung, mit Ganzkrper-Zusatz und Gammakameras zur Einzelphotonen-Emissions-Tomographie (SPECT) (IEC 61675-2:2015) This European Standard was approved by CENELEC on 2015-09-10. CENELEC members are bound to comply with t

8、he CEN/CENELEC Internal Regulations 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 Manageme

9、nt Centre or to any CENELEC member. 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 sam

10、e status as the official versions. 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, Lit

11、huania, Luxembourg, Malta, the 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 Elektrotechnisc

12、he Normung CEN-CENELEC Management 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 61675-2:2015 E BS EN 61675-2:2015EN 61675-2:2015 2 European foreword The text of document 62C/616/FDIS,

13、 future edition 2 of IEC 61675-2, prepared by IEC/SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61675-2:2015. The following dates are f

14、ixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-06-10 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-10 This document supersedes

15、 EN 61675-2:1998 and A1:2005, EN 60789:2005 and EN 61675-3:1998. Attention is drawn to the possibility that some of 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. Endorsement notice Th

16、e text of the International Standard IEC 61675-2:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1:2005 A1:2012 NOTE Harmonized as EN 60601-1:2006 (not

17、 modified). A1:2013 IEC 61675-1:2013 NOTE Harmonized as EN 61675-1:2014 (not modified). BS EN 61675-2:2015EN 61675-2:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normati

18、vely referenced in this document and are indispensable 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 co

19、mmon modifications, indicated by (mod), the 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/TR 60788 2004 Medical electrical equipment - Glossary of de

20、fined terms - - IEC 61675-1 2013 Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs EN 61675-1 2014 BS EN 61675-2:2015 2 IEC 61675-2:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope 7 2 Normative references . 7 3 Terms and definition

21、s. 7 4 Test methods . 15 4.1 General . 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

22、 performance . 31 4.2.8 Shield leakage 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 measureme

23、nt . 44 4.4.4 SPECT SYSTEM SPATIAL RESOLUTION . 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 ENERG

24、Y RESOLUTION . 58 5.2.5 COLLIMATOR dependent 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 RESOL

25、UTION (FWHM and EW) of the DETECTOR HEAD 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 BS EN 6167

26、5-2:2015IEC 61675-2:2015 IEC 2015 3 5.4.1 Calibration measurements 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 si

27、ze 59 5.4.8 DETECTOR POSITIONING TIME 59 5.4.9 NORMALIZED VOLUME SENSITIVITY . 59 5.4.10 SCATTER FRACTIONS SFiand 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 an

28、d CT image registration . 59 Index of defined terms . 60 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 Evaluati

29、on of equivalent width (EW) 23 Figure 8 Uniform source . 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 sca

30、tter fraction . 47 Figure 14 Reporting transverse resolution . 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 1

31、6 BS EN 61675-2:2015 4 IEC 61675-2:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL 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

32、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 to other activit

33、ies, 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 the subject de

34、alt 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 conditions determine

35、d 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 National Committees

36、. 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 way in which they

37、 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 IEC Publication an

38、d 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. IEC is not respo

39、nsible 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 its technical com

40、mittees 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 other IEC Publicat

41、ions. 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 the subject of pat

42、ent rights. IEC shall not be held responsible for identifying any or all such 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

43、practice. This second edition of IEC 61675-2 cancels and replaces the first 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

44、 lack of market share of SPECT-systems operated in coincidence mode all such tests have been removed. BS EN 61675-2:2015IEC 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 app

45、roval 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. In this standard, the following print types are used: TERMS DEFINED IN CLAUSE 2 OF THIS STANDARD OR LISTED IN THE INDEX OF DE

46、FINED TERMS: 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 this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.

47、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. BS EN 61675-2:2015 6 IEC 61675-2:2015 IEC 2015 INTRODUCTION The test methods specified in this part of IEC 61675 have been selected to reflect

48、 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 methods are carried out by manufacturers thereby enabling them to describe the characteristics of the sy

49、stems on a common basis. BS EN 61675-2:2015IEC 61675-2:2015 IEC 2015 7 RADIONUCLIDE IMAGING DEVICES CHARACTERISTICS AND TEST CONDITIONS Part 2: Gamma cameras for planar, wholebody, and SPECT imaging 1 Scope This part of IEC 61675 specifies terminology and test methods for describing the character-istics of GAMMA CAMERAS equipped with PARALLEL HOLE COLLIMATORS for planar imaging. Additional tests are specified for those GAMMA CAMERAS that are capable of