BS EN 61675-3-1998 Radionuclide imaging devices - Characteristics and test conditions - Gamma camera based wholebody imaging systems《放射性核素成像装置 性能和试验条件 基于γ照相机的全身成像系统》.pdf

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1、BRITISH STANDARD BS EN 61675-3:1998 IEC 61675-3: 1998 Radionuclide imaging devices Characteristics and test conditions Part 3: Gamma camera based wholebody imaging systems The European Standard EN61675-3:1998 has the status of a British Standard ICS 11.040.50BSEN61675-3:1998 This British Standard, h

2、aving been prepared underthe directionof the Health and Environment SectorBoard, was published underthe authority of the Standards Board and comes intoeffect on 15 July1998 BSI 04-1999 ISBN 0 580 29948 1 Amendments issued since publication Amd. No. Date CommentsBSEN61675-3:1998 BSI 04-1999 i Content

3、s Page National foreword ii Foreword 2 Text of EN 61675-3 3BSEN 61675-3:1998 ii BSI 04-1999 National foreword This British Standard is the English language version of EN61675-3:1998. It is identical with IEC61675-3:1998. The UK participation in its preparation was entrusted to Technical Committee CH

4、/82, Nuclear medicine instrumentation, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international an

5、d European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January1997, all IEC publications have the number60000 added to the old number. For instance, IEC27-1has been renumbered as IEC60027-1. For

6、 a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publicat

7、ions with their corresponding European publications. The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find”

8、 facility of the BSI Standards Electronic Catalogue. Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman typ

9、e. Test procedures: in italic type. Terms defined in clause2 of this standard or in Annex A: SMALL CAPITALS. For the purpose of this British Standard, any references to IEC page numbers in the text should be ignored. A British Standard does not purport to include all the necessary provisions of a co

10、ntract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, pages2 to6,

11、 an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61675-3 April 1998 ICS 11.040.50 English

12、version Radionuclide imaging devicesCharacteristics and test conditionsPart 3: Gamma camera based wholebody imaging systems (IEC61675-3:1998) Dispositifs dimagerie par radionuclides Caractristiques et conditions dessais Partie 3: Systmes dimagerie du corps entiergamma-camra (CEI61675-3:1998) Bildgeb

13、ende Systeme in der Nuklearmedizin Merkmale und Prfbedingungen Teil 3: Systeme mit Ganzkrperzusatz basierend auf einer Gammakamera (IEC 61675-3:1998) This European Standard was approved by CENELEC on1998-04-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipu

14、late 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 CENELEC member. This European Standar

15、d 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. CENELEC members are the national

16、 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 Electrotechnical Standardization Comit Europe

17、n 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 61675-3:1998EEN61675-3:1998 BSI 04-19

18、99 2 Foreword The text of document62C/211/FDIS, future edition1ofIEC61675-3, 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 CENELEC as E

19、N61675-3on1998-04-01. 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. Endorsem

20、ent notice The text of the International Standard IEC61675-3:1998was 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 references 3 2 Terminology and definitions 3 3 Test methods 3 3.1 Scanning constancy 3 3

21、.2 SPATIAL RESOLUTION without scatter 4 4 Accompanying documents 4 Annex A (informative) Index of defined terms 7 Annex ZA (normative) Normative references tointernational publicationswiththeir corresponding European publications Inside back cover Figure 1 Source position for resolution measurement

22、parallel to the direction of motion 5 Figure 2 Source position for resolution measurement perpendicular to the direction of motion 5 latest date by which the ENhas to be implemented at national level by publication of an identical national standard or by endorsement (dop)1999-01-01 latest date by wh

23、ich the national standards conflicting with the EN have to be withdrawn (dow)2001-01-01EN61675-3:1998 BSI 04-1999 3 1 General 1.1 Scope and object The object of this part of IEC61675is to specify test methods for describing the characteristics of GAMMA CAMERA BASED WHOLEBODY IMAGING SYSTEMS. As thes

24、e systems are based on Anger type GAMMA CAMERAS this part of IEC61675should be read in conjuction with IEC60789. Two additional tests, scanning speed constancy, and system SPATIAL RESOLUTION without scatter, shall be performed. Measurement of system uniformity for wholebody imaging systems is possib

25、le but difficult to perform because of the requirement for large and uniform sources. Most of the potential problems that could affect uniformity will also affect the system resolution, and therefore such a uniformity test is not included in this standard. The test methods specified in this part of

26、IEC61675have been selected to reflect as much as possible the clinical use of GAMMA CAMERA BASED WHOLEBODY IMAGING SYSTEMS. It is intended that the test methods be carried out by manufacturers, thereby enabling them to describe the characteristics of GAMMA CAMERA BASED WHOLEBODY IMAGING SYSTEMS. 1.2

27、 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IEC61675. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements

28、based on this part of IEC61675are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC60788:1984, Medical radiology Terminology. IEC60789:19

29、92, Characteristics and test conditions of radionuclide imaging devices Anger type gamma cameras. IEC61675-2:, Radionuclide imaging devices Characteristics and test conditions Part2: Single photon emission computed tomographs. 2 bTerminology and definitions For the purposes of this part of IEC61675,

30、 the definitions given in IEC60789 and IEC60788, and IEC61675-2 (seeAnnex A), and the following definition apply. 2.1 GAMMA CAMERA BASED WHOLEBODY IMAGING SYSTEM equipment for scintigraphy, employing one or two DETECTOR HEAD(S), in which the image is formed by moving the DETECTOR HEAD(S) and the obj

31、ect relative to each other and relating output information of the RADIOLOGICAL IMAGE 3 Test methods All measurements shall be performed with PULSE AMPLITUDE ANALYSER WINDOW as specified in Table 1 of IEC60789. Additional measurements with other settings as specified by the manufacturer can be perfor

32、med. Before the measurements are performed, the system shall be adjusted by the procedure normally used by the manufacturer for an installed unit and shall not be adjusted specially for the measurement of specific parameters. Measurements of performance parameters in the planar mode of operation are

33、 a prerequisite. A complete set of performance parameters shall be measured as specified in IEC60789. Unless otherwise specified, measurements shall be carried out at COUNT RATES not exceeding 20000 counts per second. 3.1 Scanning constancy Scanning constancy shall be measured using a POINT SOURCE a

34、ttached to the DETECTOR HEAD and expressed as COUNT RATE deviation along the full scanning length. 3.1.1 RADIONUCLIDE The RADIONUCLIDE to be employed for this measurement shall be 99m Tc or 57 Co. 3.1.2 Source The source shall be a POINT SOURCE attached to the COLLIMATOR at the centre of the field o

35、f view. The ACTIVITY of the source shall be adjusted to yield a COUNT RATE between10000 and 20000counts per second, through a20% analyzer window, in the DETECTOR FIELD OF VIEW. 3.1.3 Data acquisition and analysis The scan speed and the acquisition matrix shall be in the range recommended for clinica

36、l use. Two scans shall be performed along the full scanning length using different speeds. The image of the POINT SOURCE shall be recorded.EN61675-3:1998 4 BSI 04-1999 A profile through the image of the POINT SOURCE in the direction of the motion should yield a constant count value. This profile sha

37、ll have a width between20mm and30mm in the direction perpendicular to the direction of motion, and shall contain at least10000counts per pixel. The analysis shall exclude the areas at the ends of the profile which are affected by the spatial resolution in the scanning direction. 3.1.4 Report For the

38、 region of analysis, report a graph of the percent deviation from the mean count value. In addition report the value of the maximum percent deviation from the mean. Any deviation greater than expected from Poisson statistics standard deviations is indicative of non-uniform scanning motion and shall

39、be stated. The COLLIMATOR and the scan speeds used in performing the measurements shall be also reported. 3.2 SPATIAL RESOLUTION without scatter SPATIAL RESOLUTION without scatter shall be measured parallel and perpendicular to the direction of motion, and expressed as FULL WIDTH AT HALF MAXIMUM (FW

40、HM) of the LINE SPREAD FUNCTION. 3.2.1 RADIONUCLIDE The RADIONUCLIDE to be employed for this measurement shall be 99m Tc or 57 Co. 3.2.2 Source The sources shall consist of two capillary tubes, each having an inside diameter of less than or equal to1mm and a length equal to the width of the scanned

41、field of view perpendicular to the direction of motion. NOTEIf a line source of the length specified above is difficult to manufacture or to handle, either a shorter line can be used and scanned in the required number of positions to cover the specified length, or a number of shorter lines spanning

42、the field of view can be scanned simultaneously. The activity of both sources shall be approximately equal and shall be adjusted to yield a COUNT RATE between10000 and20000counts per second, through a20% analyzer window, with both capillary tubes in the detector field of view. 3.2.3 Location of sour

43、ces The sources shall be placed on the wholebody scanning table. For the measurement of resolution parallel to the direction of motion, one capillary tube shall be placed at the centre of the scanned field of view, perpendicular to the direction of motion to within1mm; the second source shall be pla

44、ced parallel to the first one, at a distance of100mm as shown in Figure 1. For the measurement of resolution perpendicular to the direction of motion, one capillary tube shall be placed at the centre of the scanned field of view, parallel to the direction of motion to within1mm; the second source sh

45、all be placed parallel to the first one, at a distance of 100mm as shown in Figure 2. 3.2.4 Data acquisition The scan speed shall be in the range recommended for clinical use. Scans shall be performed both above and below the table for the two source positions described in3.2.3. The camera shall be

46、positioned at a distance of100mm from the sources to the face of the COLLIMATOR. The sampling, perpendicular to the tubes, shall be no coarser than25% of the FWHM of the SPATIAL RESOLUTION with the COLLIMATOR being used. The measured quantity, i.e.number of counts, shall be integrated in the directi

47、on parallel to the sources within sets of areas with lengths not more than30mm. The areas shall about each other. 3.2.5 Calculation of FWHM The FWHM shall be calculated in each segment (length of integrated area as specified in3.2.4) of the central capillary tube, using a gaussian fit method. The va

48、lues of the FWHM shall be averaged separately for the tubes parallel and perpendicular to the direction of motion, for the measurement above and below the table. The values shall be stated in millimetres. 3.2.6 Report The FWHM values shall be reported separately for the measurements above and below

49、the table and in the directions parallel and perpendicular to the direction of motion. The COLLIMATOR and scan speed used in performing the measurements shall be reported. 4 ACCOMPANYING DOCUMENTS A document shall accompany each GAMMA CAMERA BASED WHOLEBODY IMAGING SYSTEM and shall include the following information. 4.1 All items described in clause4 of IEC60789. 4.2 Scanning constancy as specified in3.1 of this standard. 4.3 SPATIAL RESOLUTION as specified in3.2 of this standard.EN61675-3:1998 BSI 04-1999 5 Figure 1 Source position