EN 61675-1-1998 en Radionuclide imaging devices Characteristics and test conditions Part 1 Positron emission tomographs (Incorporates Amendment A1 2008)《放射性核素成像设备 性能和试验条件 第1部分 正电子发.pdf

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1、BRITISH STANDARD BS EN 61675-1:1998 +A1:2008 Radionuclide imaging devices Characteristics and test conditions Part 1: Positron emission tomographs ICS 11.040.50; 35.240.80 BS EN 61675-1:1998+A1:2008 This British Standard was published under the authority of the Standards Board and comes into effect

2、on 15 May 1998 BSI 2009 ISBN 978 0 580 650499 National foreword This British Standard is the UK implementation of EN 61675-1:1998+A1:2008. It is identical with IEC 61675-1:1998, incorporating amendment 1:2008. It supersedes BS EN 61675-1:1998 which is withdrawn. The start and finish of text introduc

3、ed or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by !“. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical

4、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 be obtained on request to its secretary. This publication does not purport to include all the necessary provisions o

5、f a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication Date Comments 31 January 2009 Implementation of IEC amendment 1:2008 with CENELEC endorsement A1:2008EUROP

6、EAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN61675-1:1998+A1 July 2008 ICS 11.040.50 English version Radionuclide imaging devices Characteristicsandtestconditions Part1:Positronemissiontomographs (IEC 61675-1:1998) Dispositifs dimagerie par radionuclides Caractristiques et conditons dessai Partie1

7、:Tomographes misssion depositrons (CEI 61675-1:1998) Bildgebende Systeme in der Nuklearmedizin Merkmale und Prfbedingungen Teil1:Positronen-Emissions-Tomographie (IEC 61675-1:1998) This European Standard was approved by CENELEC on 1998-01-01. CENELEC members are bound to comply with the CEN/CENELEC

8、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 Central Secretariat or to any CENEL

9、EC 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 Central Secretariat has the same status as the official versions.

10、CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechni

11、cal Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1998 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61675

12、-1:1998 E2 Foreword The text of document62C/205/FDIS, future edition1 of IEC61675-1, prepared by SC62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENE

13、LEC as EN61675-1 on 1998-01-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex ZA is normative and Annex A is informative. Annex ZA has been added by CENELEC

14、. Endorsement notice The text of the International Standard IEC61675-1:1998 was approved by CENELEC as a European Standard without any modification. Contents Page Foreword 2 1 General 3 1.1 Scope and object 3 1.2 Normative reference 3 2 Terminology and definitions 3 3 Test methods 8 3.1 SPATIAL RESO

15、LUTION 8 3.2 RECOVERY COEFFICIENT 11 3.3 Tomographic sensitivity 12 3.4 Uniformity 14 3.5 COUNT RATE CHARACTERISTIC 14 3.6 Scatter measurement 17 3.7 ATTENUATION correction 18 4 ACCOMPANYING DOCUMENTS 20 Annex A (informative) Index of defined terms 35 Annex ZA (normative) Normative referencestointer

16、national publications with their corresponding European publications 36 Figure 1 Cylindrical head phantom 22 Figure 2 Cross-section of body phantom 23 Figure 3 Arm phantom 24 Figure 4 Phantom insert with hollow spheres 25 Figure 5 Phantom insert with holders for the scatter source 26 Figure 6 Phanto

17、m insert for the evaluation of ATTENUATION correction 27 Figure 7 Phantom configuration for COUNT RATE measurements according to3.5.3.1.2 (cardiac imaging) 28 Figure 8 Scheme of the evaluation ofCOUNT LOSS correction 29 Figure 9 Evaluation of ATTENUATION correction 30 Figure 10 Evaluation of SCATTER

18、 FRACTION 31 Figure 11 Evaluation of FWHM 32 Figure 12 Evaluation of EQUIVALENT WIDTH (EW) 33 34 Table 1 RADIONUCLIDES to be used in performance measurements 21 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop

19、) 1998-11-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 1998-11-01 Foreword to amendment A1 The text of document62C/419/CDV, future amendment 1 to IEC61675-1:1998, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosim

20、etry, of IEC TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC Parallel Unique Acceptance Procedure and was approved by The following dates were fixed: latest date by which the amendment has to be implemented at national level by publication of an identical national st

21、andard or by endorsement (dop) 2009-02-01 latest date by which the national standards conflicting with the amendment have to be withdrawn (dow) 2011-05-01 Endorsement notice The text of amendment 1:2008 to the International Standard IEC61675-1:1998 was approved by CENELEC as an amendment to the Euro

22、peanStandard without any modification. CENELEC as amendment A1 to EN 61675-1:1998 BS EN 61675-1:1998+A1:2008 Figure 13 Phantom position and location of screws for abdominal imaging on 2008-05-01. BSI 2008 3 1 General 1.1 Scope and object This part of IEC61675 specifies terminology and test methods f

23、or declaring the characteristics 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 IEC61675 have been selected to reflect as much as possible the clin

24、ical use of POSITRON 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.

25、This standard does 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 follo

26、wing normative document contains provisions which, through reference in this text, constitute provisions of this part of IEC61675. 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 IEC61675 ar

27、e encouraged to 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. IEC60788:1984, Medical radiology Terminology. 2 Terminology and definitions For the purpose

28、 of this part of IEC61675, the definitions given in IEC60788 (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, f

29、or example collimation, 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 2.1.2 EMISSION COMPUTED TOMOGRAPHY (ECT) imaging method for the representation of the spatial distrib

30、ution 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 property which determine

31、s the image along the direction of the PROJECTION BEAM NOTEThis 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 the physical property

32、 which determines the image is integrated during the measurement process. Its shape is limited by SPATIAL RESOLUTION in all three dimensions NOTEThe 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

33、elements operated in coincidence. BS EN 61675-1:1998+A1:2008 BSI 2008 4 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

34、 ANGLE is displayed 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

35、plane in the OBJECT SLICE NOTEUsually 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 NOTEFor a circular POSITRON EMISSION TOMOGRAPH, the SYSTEM AXIS is the

36、axis through 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 2.1.2.8.1 TRANSVERSE FIELD OF VIEW dimensions of a s

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

38、ions 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 WIDTH 2.1.2.8.3 TOTAL FIELD O

39、F 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 tomographic device, which detects

40、 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 BS EN 61675-1:1998+A1:2008 BSI 2008 5 2.1.3.3 COINCIDENCE DETECTION a method whi

41、ch checks whether two opposing detectors have detected one photon each simultaneously. By this method the two photons are concatenated into one event NOTEThe COINCIDENCE DETECTION between two opposing detector elements serves as an electronic collimation to define the corresponding PROJECTION BEAM o

42、r LINE OF RESPONSE (LOR), respectively. 2.1.3.4 COINCIDENCE WINDOW time interval during which two detected photons are considered being simultaneous 2.1.3.5 LINE OF RESPONSE (LOR) the axis of the PROJECTION BEAM NOTEIn PET, it is the line connecting the centres of two opposing detector elements oper

43、ated in coincidence. 2.1.3.6 TOTAL COINCIDENCES sum of all coincidences detected 2.1.3.6.1 TRUE COINCIDENCE result of COINCIDENCE DETECTION of two gamma events originating from the same positron annihilation 2.1.3.6.2 SCATTERED TRUE COINCIDENCE TRUE COINCIDENCE where at least one participating photo

44、n was scattered before the COINCIDENCE DETECTION 2.1.3.6.3 UNSCATTERED TRUE COINCIDENCE the difference between TRUE COINCIDENCES and SCATTERED TRUE COINCIDENCES 2.1.3.6.4 RANDOM COINCIDENCE result of COINCIDENCE DETECTION in which both participating photons emerge from different positron annihilatio

45、ns 2.1.3.7 SINGLES RATE COUNT RATE measured without COINCIDENCE DETECTION, but with energy discrimination 2.1.4 Reconstruction 2.1.4.1 TWO-DIMENSIONAL RECONSTRUCTION in TWO-DIMENSIONAL RECONSTRUCTION, the data are rebinned prior to reconstruction into SINOGRAMS, which are the PROJECTION data of tran

46、sverse slices, which are considered being independent of each other and being perpendicular to the SYSTEM AXIS. So, each event will be assigned, in the axial direction, to that transverse slice passing the midpoint of the corresponding LINE OF RESPONSE. Any deviation from perpendicularity to the SYS

47、TEM AXIS is neglected. The data are then reconstructed by two-dimensional methods, i.e.each slice is reconstructed from its associated SINOGRAM, independent of the rest of the data set NOTEThis is the standard method of reconstruction for POSITRON EMISSION TOMOGRAPHS using small axial acceptance ang

48、les, i.e.utilizing septa. For POSITRON EMISSION TOMOGRAPHS using large axial acceptance angles, i.e.without septa, this method is also called “single slice rebinning”. BS EN 61675-1:1998+A1:2008 BSI 2008 6 2.1.4.2 THREE-DIMENSIONAL RECONSTRUCTION in THREE-DIMENSIONAL RECONSTRUCTION, the LINES OF RESPONSE are not restricted to being perpendicular to the SYSTEM AXIS. So, a LINE OF RESPONSE may pass several transverse slices. Consequently, transverse slices cannot be reconstructed independent of each other. Each slice has to be reconstructed utilizi