EN 61675-1-2014 en Radionuclide imaging devices - Characteristics and test conditions - Part 1 Positron emission tomographs.pdf

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1、BSI Standards PublicationRadionuclide imaging devices Characteristics and test conditionsPart 1: Positron emission tomographsBS EN 61675-1:2014National forewordThis British Standard is the UK implementation of EN 61675-1:2014. It isidentical to IEC 61675-1:2013. It supersedes BS EN 61675-1:1998+A1:2

2、008which is withdrawn.The UK participation in its preparation was entrusted by Technical Com-mittee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this committee can

3、 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 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 76378 6ICS 11.040.50; 35.240

4、.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2014.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 61675-1:2014E

5、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61675-1 June 2014 ICS 11.040.50 Supersedes EN 61675-1:1998 English Version Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs (IEC 61675-1:2013) Dispositifs dimagerie par radionuclides - Caract

6、ristiques et conditions dessai - Partie 1: Tomographes mission de positrons (CEI 61675-1:2013) Bildgebende Systeme in der Nuklearmedizin - Merkmale und Prfbedingungen - Teil 1: Positronen-Emissions-Tomographen (IEC 61675-1:2013) This European Standard was approved by CENELEC on 2013-10-30. CENELEC m

7、embers are bound to comply with the 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 applic

8、ation to the CEN-CENELEC Management 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-CENE

9、LEC Management Centre has the same 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, Ice

10、land, Ireland, Italy, Latvia, Lithuania, 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 Europ

11、isches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 61675-1:2014 E BS EN 61675-1:2014EN 61675-1:2014 - 2 - Foreword The te

12、xt of document 62C/550/CDV, future edition 2 of IEC 61675-1, 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 61675-1:

13、2014. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2014-12-13 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016

14、-10-30 This document supersedes EN 61675-1:1998. 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 The text of the In

15、ternational Standard IEC 61675-1:2013 was approved by CENELEC as a European Standard without any modification. BS EN 61675-1:2014- 3 - EN 61675-1:2014 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in wh

16、ole or in part, are normatively 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 When an international publicatio

17、n has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 61675-1:2014 2 61675-1 IEC:2013 CONTENTS INTRODUCTION . 6 1 Scope 7 2 Normative referenc

18、es 7 3 Terms and definitions 7 4 Test methods . 13 4.1 General 13 4.2 SPATIAL RESOLUTION . 13 4.2.1 General 13 4.2.3 Method . 14 4.2.4 Analysis 15 4.2.5 Report 17 4.3 Tomographic sensitivity 18 4.3.1 General 18 4.3.2 Purpose 18 4.3.3 Method . 18 4.3.4 Analysis 19 4.3.5 Report 20 4.4 Uniformity 20 4.

19、5 Scatter measurement . 20 4.5.1 General 20 4.5.2 Purpose 20 4.5.3 Method . 20 4.5.4 Analysis 21 4.5.5 Report 22 4.6 PET COUNT RATE PERFORMANCE 23 4.6.1 General 23 4.6.2 Purpose 23 4.6.3 Method . 23 4.6.4 Analysis 24 4.6.5 Report 26 4.7 Image quality and quantification accuracy of source ACTIVITY co

20、ncentrations . 26 4.7.1 General 26 4.7.2 Purpose 26 4.7.3 Method . 27 4.7.4 Data analysis 31 4.7.5 Report 34 5 ACCOMPANYING DOCUMENTS 35 5.1 General 35 5.2 Design parameters . 35 5.3 Configuration of the tomograph 36 5.4 SPATIAL RESOLUTION . 36 5.5 Sensitivity 36 5.6 SCATTER FRACTION 36 5.7 COUNT RA

21、TE performance . 36 BS EN 61675-1:201461675-1 IEC:2013 3 5.8 Image quality and quantification accuracy of source ACTIVITY concentrations . 36 Bibliography 37 Index of defined terms 38 Figure 1 Evaluation of FWHM 16 Figure 2 Evaluation of EQUIVALENT WIDTH (EW) 17 Figure 3 Scatter phantom configuratio

22、n and position on the imaging bed . 19 Figure 4 Evaluation of SCATTER FRACTION . 22 Figure 5 Cross-section of body phantom 27 Figure 6 Phantom insert with hollow spheres . 28 Figure 7 Image quality phantom and scatter phantom position for whole body scan acquisition 29 Figure 8 Placement of ROIs in

23、the phantom background 32 BS EN 61675-1:2014 6 61675-1 IEC:2013 INTRODUCTION 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 standard describes test conditions in accordance with this acqui

24、sition characteristic. In addition, today a POSITRON EMISSION TOMOGRAPH often includes X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT). For this standard PET-CT hybrid devices are considered to be state of the art, dedicated POSITRON EMISSION TOMOGRAPHS not including the X-ray component being special c

25、ases only. The test methods specified in this part of IEC 61675 have been selected to reflect as much as possible the clinical use of POSITRON EMISSION TOMOGRAPHS. It is intended that the tests be carried out by MANUFACTURERS, thereby enabling them to declare the characteristics of POSITRON EMISSION

26、 TOMOGRAPHS in the ACCOMPANYING DOCUMENTS. This standard does not indicate which tests will be performed by the MANUFACTURER on an individual tomograph. BS EN 61675-1:201461675-1 IEC:2013 7 RADIONUCLIDE IMAGING DEVICES CHARACTERISTICS AND TEST CONDITIONS Part 1: Positron emission tomographs 1 Scope

27、This part of IEC 61675 specifies terminology and test methods for declaring the characteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDEs by COINCIDENCE DETECTION. No test has been specified to characterize the

28、uniformity of reconstructed images, because all methods known so far will mostly reflect the noise in the image. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the

29、edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60788:2004, Medical electrical equipment Glossary of defined terms 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60

30、788:2004 and the following apply. 3.1 tomography radiography of one or more layers within an object SOURCE: IEC 60788:2004, rm-41-15 3.1.1 transverse tomography TOMOGRAPHY that slices a three-dimensional object into a stack of OBJECT SLICES which are considered as being two-dimensional and independe

31、nt from each other and at which the IMAGE PLANES are perpendicular to the SYSTEM AXIS 3.1.2 emission computed tomography ECT imaging method for the representation of the spatial distribution of incorporated RADIONUCLIDES in selected two-dimensional slices through the object 3.1.2.1 projection transf

32、ormation 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 property which determines the image along the direction of the PROJECTION BEAM BS EN 61675-1:2014 8 61675-1 IEC:2013 Note 1 to entry: This

33、process is mathematically described by line integrals in the direction of PROJECTION (along the LINE OF RESPONSE) and called radon-transform. 3.1.2.2 projection beam beam that determines the smallest possible volume in which the physical property which determines the image is integrated during the m

34、easurement process Note 1 to entry: Its shape is limited by SPATIAL RESOLUTION in all three dimensions. Note 2 to entry: The PROJECTION BEAM mostly has the shape of a long thin cylinder or cone. In POSITRON EMISSION TOMOGRAPHY, it is the sensitive volume between two detector elements operated in coi

35、ncidence. 3.1.2.3 projection angle angle at which the PROJECTION is measured or acquired 3.1.2.4 sinogram two-dimensional display of all one-dimensional PROJECTIONs of an OBJECT SLICE, as a function of the PROJECTION ANGLE Note 1 to entry: The PROJECTION ANGLE is displayed on the ordinate, the linea

36、r projection coordinate is displayed on the abscissa. 3.1.2.5 object slice physical property that correspondes to a slice in the object and that determines the measured information and which is displayed in the tomographic image 3.1.2.6 image plane a plane assigned to a plane in the OBJECT SLICE Not

37、e 1 to entry: Usually the IMAGE PLANE is the midplane of the corresponding OBJECT SLICE. 3.1.2.7 system axis axis of symmetry, characterized by geometrical and physical properties of the arrangement of the system Note 1 to entry: For a circular POSITRON EMISSION TOMOGRAPH, the SYSTEM AXIS is the axi

38、s through the centre of the detector ring. For tomographs with rotating detectors it is the axis of rotation. 3.1.2.8 tomographic volume juxtaposition of all volume elements which contribute to the measured PROJECTIONs for all PROJECTION ANGLES 3.1.2.8.1 transverse field of view dimensions of a slic

39、e through the TOMOGRAPHIC VOLUME, perpendicular to the SYSTEM AXIS Note 1 to entry: For a circular TRANSVERSE FIELD OF VIEW, it is described by its diameter. Note 2 to entry: For non-cylindrical TOMOGRAPHIC VOLUMES the TRANSVERSE FIELD OF VIEW may depend on the axial position of the slice. 3.1.2.8.2

40、 axial field of view AFOV field which is characterized by dimensions of a slice through the TOMOGRAPHIC VOLUME, parallel to and including the SYSTEM AXIS BS EN 61675-1:201461675-1 IEC:2013 9 Note 1 to entry: In practice, it is specified only by its axial dimension, given by the distance between the

41、centre of the outmost defined IMAGE PLANEs plus the average of the measured AXIAL RESOLUTION. 3.1.2.8.3 total field of view field which is characterized by dimensions (three-dimensional) of the TOMOGRAPHIC VOLUME 3.1.3 positron emission tomography PET EMISSION COMPUTED TOMOGRAPHY utilizing the ANNIH

42、ILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION 3.1.3.1 positron emission tomograph tomographic device, which detects the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION 3.1.3.2 annihilation radiation ionizing radiation that is produce

43、d when a particle and its antiparticle interact and cease to exist 3.1.3.3 coincidence detection method which checks whether two opposing detectors have detected one photon each simultaneously Note 1 to entry: By this method the two photons are concatenated into one event. Note 2 to entry: The COINC

44、IDENCE DETECTION between two opposing detector elements serves as an electronic collimation to define the corresponding PROJECTION BEAM or LINE OF RESPONSE (LOR), respectively. 3.1.3.4 coincidence window time interval during which two detected photons are considered as being simultaneous 3.1.3.5 lin

45、e of response LOR axis of the PROJECTION BEAM Note 1 to entry: In PET, it is the line connecting the centres of two opposing detector elements operated in coincidence. 3.1.3.6 total coincidences sum of all coincidences detected 3.1.3.6.1 true coincidence result of COINCIDENCE DETECTION of two gamma

46、events originating from the same positron annihilation 3.1.3.6.2 scattered true coincidence TRUE COINCIDENCE where at least one participating photon was scattered before the COINCIDENCE DETECTION BS EN 61675-1:2014 10 61675-1 IEC:2013 3.1.3.6.3 unscattered true coincidence difference between TRUE CO

47、INCIDENCES and SCATTERED TRUE COINCIDENCES 3.1.3.6.4 random coincidence result of a COINCIDENCE DETECTION in which participating photons do not originate from the same positron annihilation. 3.1.3.7 singles rate COUNT RATE measured without COINCIDENCE DETECTION, but with energy discrimination 3.1.4

48、two-dimensional reconstruction image reconstruction at which data are rebinned prior to reconstruction into SINOGRAMS, which are the PROJECTION data of transverse slices which are considered as being independent of each other and being perpendicular to the SYSTEM AXIS 3.1.5 three-dimensional reconst

49、ruction image reconstruction at which the LINES OF RESPONSE are not restricted to being perpendicular to the SYSTEM AXIS so that a LINE OF RESPONSE may pass several transverse slices 3.2 image matrix matrix in which each element corresponds to the measured or calculated physical property of the object at the location described by the coordinates of this MATRIX ELEMENT 3.2.1 matrix element smallest unit of an IMAGE MATRIX, which is assigned in location and size to a certain volume element of th