EN 60789-2005 en Medical electrical equipment C Characteristics and test conditions of radionuclide imaging devices Anger type gamma cameras (Remains Current)《医用电气设备 放射性核素成象装置的特性和试.pdf

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1、BRITISH STANDARDBS EN 60789:2005Medical electrical equipment Characteristics and test conditions of radionuclide imaging devices Anger type gamma camerasThe European Standard EN 60789:2005 has the status of a British StandardICS 11.040.50g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g4

2、4g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 60789:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 February 2006 BSI 13 February 2006ISB

3、N 0 580 47176 4National forewordThis British Standard is the official English language version of EN 60789:2005. It is identical with IEC 60789:2005. It supersedes BS EN 60789:1994 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical e

4、quipment in medical practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards whi

5、ch implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publicat

6、ion does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/

7、European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, page

8、s 2 to 29 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARD EN 60789 NORME EUROPENNE EUROPISCHE NORM December 2005 CENELEC European Committee for Electrotechnical

9、 Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 6078

10、9:2005 E ICS 11.040.50 Supersedes EN 60789:1993English version Medical electrical equipment Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras (IEC 60789:2005) Appareils lectromdicaux - Caractristiques et conditions dessai des dispositifs dimagerie par rad

11、ionuclides Gamma camras de type Anger (CEI 60789:2005) Medizinische elektrische Gerte - Merkmale und Prfbedingungen fr bildgebende Systeme in der Nuklearmedizin Einkristall-Gamma-Kameras (IEC 60789:2005) This European Standard was approved by CENELEC on 2005-11-01. CENELEC members are bound to compl

12、y 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 application to the Central Secr

13、etariat 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 Central Secretariat has the same status as

14、the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia

15、, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 60789:2005 2 Foreword The text of document 62C/388/FDIS, future edition 3 of IEC 60789, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was

16、submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60789 on 2005-11-01. This European Standard supersedes EN 60789:1993. With respect to EN 60789:1993, the measurement of intrinsic point source sensitivity variation has been removed, the subclauses SYSTEM SENSITIVITY (4.2),

17、 SPATIAL RESOLUTION (4.3), NON-UNIFORMITY OF RESPONSE (4.5), INTRINSIC MULTIPLE WINDOW SPATIAL REGISTRATION (4.7) and COUNT RATE CHARACTERISTIC (4.8) have been reformulated (although the procedures are mostly unchanged) and some small editorial changes have been made. The following dates were fixed:

18、 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2006-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2008-11-01 In this standard the following print type

19、s are used: requirements, compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, introductions, general statements, exceptions and reference: in smaller roman type; test specifications: in italic type; TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD LISTED IN AN

20、NEX B: SMALL CAPITALS. The requirements are followed by specifications for the relevant tests. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60789:2005 was approved by CENELEC as a European Standard without any modification. _ 3 EN 60789:2005 CON

21、TENTS INTRODUCTION.4 1 Scope 5 2 Normative references .5 3 Terms and definitions .5 4 Test methods .8 4.1 General requirements 8 4.2 SYSTEM SENSITIVITY 8 4.3 SPATIAL RESOLUTION .10 4.4 SPATIAL NON-LINEARITY .12 4.5 NON-UNIFORMITY OF RESPONSE 13 4.6 INTRINSIC ENERGY RESOLUTION.15 4.7 INTRINSIC MULTIP

22、LE WINDOW SPATIAL REGISTRATION .15 4.8 COUNT RATE CHARACTERISTIC 17 4.9 Shield leakage test 18 5 ACCOMPANYING DOCUMENTS .19 Annex ZA (normative) Normative references to international publications with their Bibliography .26 Index of defined terms 27 Figure 1 Cuvette 19 Figure 2 Cylindrical phantom20

23、 Figure 3 Uniform source.20 Figure 4 Slit phantom for measurement of intrinsic resolution and SPATIAL NON-LINEARITY 21 Figure 5 Source arrangement for intrinsic measurements (4.3.5, 4.4.1, 4.5.4 and 4.6) .22 Figure 6 Small shielded liquid source .23 Figure 7 Measurement of FWHM 24 Figure 8 Evaluatio

24、n of EQUIVALENT WIDTH (EW)25 Table 1 Radionuclides and energy windows to be used for performance measurements8 corresponding European publications29 EN 60789:2005 4 INTRODUCTION The test methods specified in this standard have been selected to reflect as much as possible the clinical use of GAMMA CA

25、MERAS. It is intended that the test methods be carried out by manufacturers, thereby enabling them to describe the characteristics of GAMMA CAMERAS on a common basis. 5 EN 60789:2005 MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS AND TEST CONDITIONS OF RADIONUCLIDE IMAGING DEVICES ANGER TYPE GAMMA CAM

26、ERAS 1 Scope This International Standard specifies test methods for declaring the characteristics of Anger type GAMMA CAMERAS. The latter are composed of a collimator, a detector shield and a radiation detector assembly, together with recording and display devices. It is not within the scope of this

27、 standard to address the safety requirements to be followed by manufacturers according to IEC 60601-1. 2 Normative references The following referenced documents are for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition

28、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 definitions given in IEC 60788 (see Index of defined terms) and the following apply. 3.1 ENERGY WINDOW

29、range defining the energy signals accepted by the device for further processing 3.2 DETECTOR FIELD OF VIEW FOV region of the detector within which events are included in the display image, and for which all performance specifications are provided 3.3 COLLIMATOR FRONT FACE surface of the COLLIMATOR w

30、hich is closest to the object being imaged 3.4 COLLIMATOR BACK FACE surface of the COLLIMATOR which is closest to the RADIATION DETECTOR ASSEMBLY 3.5 ENTRANCE FIELD OF A COLLIMATOR area bounded by the shortest line which is tangential to the outside edges of the peripheral COLLIMATOR apertures on th

31、e COLLIMATOR FRONT FACE EN 60789:2005 6 3.6 EXIT FIELD OF A COLLIMATOR area bounded by the shortest line which is tangential to the outside edges of the peripheral COLLIMATOR apertures on the COLLIMATOR BACK FACE 3.7 COLLIMATOR AXIS straight line which passes through the geometrical centre of the EX

32、IT and ENTRANCE FIELDS of the COLLIMATOR 3.8 PARALLEL HOLE COLLIMATOR COLLIMATOR with a number of apertures, the axes of which are parallel 3.9 PIN-HOLE COLLIMATOR COLLIMATOR with one small aperture in a plane in front of the RADIATION DETECTOR ASSEMBLY 3.10 ADDRESS PILE UP false address calculation

33、 of an artificial event which passes the ENERGY WINDOW, but is formed from two or more events by the PILE UP EFFECT 3.11 PILE UP EFFECT false measurement of the pulse amplitude, due to the absorption of two or more gamma rays, reaching the same radiation detector within the RESOLVING TIME IEC 61675-

34、1, definition 2.7.4.1 3.12 SYSTEM SENSITIVITY with a specified COLLIMATOR and ENERGY WINDOW, the ratio of the COUNT RATE of the DETECTOR HEAD to the ACTIVITY of a plane source of specific dimensions and containing a specified radionuclide placed perpendicular to and centred on the COLLIMATOR AXIS un

35、der specified conditions NOTE See also Figure 2. 3.13 INTRINSIC LINE SPREAD FUNCTION line spread function measured with a collimated line source in front of the DETECTOR HEAD without COLLIMATOR 3.14 DETECTOR HEAD LINE SPREAD FUNCTION line spread function measured with an uncollimated line source at

36、a specified distance Z from the COLLIMATOR FRONT FACE 3.15 EQUIVALENT WIDTH EW width of a rectangle having the same area as the LSF and a height equal to the maximum value of the LSF 7 EN 60789:2005 3.16 SPATIAL RESOLUTION ability to concentrate the count density distribution in the image of a POINT

37、 SOURCE to a point IEC 61675-1, definition 2.4 3.17 SYSTEM SPATIAL RESOLUTION SPATIAL RESOLUTION in a scattering medium for a specified COLLIMATOR, or a specified radionuclide, and at a specified distance from the COLLIMATOR FRONT FACE 3.18 INTRINSIC SPATIAL RESOLUTION SPATIAL RESOLUTION in air for

38、a specified radionuclide excluding the COLLIMATOR 3.19 INTRINSIC ENERGY SPECTRUM measured histogram of pulse heights for the DETECTOR HEAD without COLLIMATOR NOTE The pulse height should be expressed as corresponding energy. 3.20 INTRINSIC ENERGY RESOLUTION FULL WIDTH AT HALF MAXIMUM of the full ene

39、rgy absorption peak in the INTRINSIC ENERGY SPECTRUM for a specified radionuclide 3.21 MULTIPLE WINDOW SPATIAL REGISTRATION measured position of a source as a function of the ENERGY WINDOW setting 3.22 INTRINSIC NON-UNIFORMITY OF RESPONSE NON-UNIFORMITY OF RESPONSE of the DETECTOR HEAD without COLLI

40、MATOR 3.23 SYSTEM NON-UNIFORMITY OF RESPONSE NON-UNIFORMITY OF RESPONSE of the DETECTOR HEAD with COLLIMATOR 3.24 SPATIAL NON-LINEARITY deviations of the image of a straight line source from a straight line 3.25 INTRINSIC SPATIAL NON-LINEARITY SPATIAL NON-LINEARITY of the DETECTOR HEAD without COLLI

41、MATOR 3.26 COUNT LOSS difference between measured COUNT RATE and TRUE COUNT RATE, which is caused by the finite RESOLVING TIME of the instrument IEC 61675-1, definition 2.7.1 EN 60789:2005 8 3.27 COUNT RATE number of counts per unit of time IEC 61675-1, definition 2.7.2 4 Test methods 4.1 General re

42、quirements All measurements shall be performed with the energy window settings specified in Table 1. Table 1 Radionuclides and energy windows to be used for performance measurements Radionuclide Energy window keV 99mTc 141, with a tolerance of 7,5 % 131I 364, with a tolerance of 10 % 67Ga 93, 184, 3

43、00, with a tolerance of 20 % 68Ga 511, with a tolerance of 10 % NOTE Because the characteristics of a gamma camera may change noticeably between 122 keV (57Co) and 141 keV (99mTc), the former is not included as a suitable radionuclide. However, it may be useful in some circumstances, e.g. for qualit

44、y control. Additional measurements with other settings, as specified by the manufacturer, can be performed. Before the measurements are performed, the camera shall be adjusted by the procedure normally used by the manufacturer for an installed unit and shall not be adjusted specially for the measure

45、ment of specific parameters. Unless otherwise specified, measurements shall be carried out at count rates not exceeding 20 000 counts per second. 4.2 SYSTEM SENSITIVITY 4.2.1 General Sensitivity is a parameter that characterizes the effectiveness of a system to identify the radiation emitted from a

46、RADIOACTIVE SOURCE, i.e. the rate at which events are detected in the presence of a RADIOACTIVE SOURCE in the limit of low ACTIVITY where COUNT LOSSES are negligible. The measured COUNT RATE for a given ACTIVITY and RADIONUCLIDE depends on many factors, including the detector material, its size and

47、thickness, the size and shape of the RADIOACTIVE SOURCE including its absorption and scatter properties, and instruments dead time, energy thresholds and COLLIMATOR. 4.2.2 Purpose The purpose of this measurement is to determine the detected rate of events per unit of ACTIVITY for a standard volume s

48、ource of given dimensions and a specified COLLIMATOR. 4.2.3 Method The SYSTEM SENSITIVITY test places a known amount of ACTIVITY of a specified RADIONUCLIDE within the DETECTOR FIELD OF VIEW of the GAMMA CAMERA and observes the resulting COUNT RATE. From these values the SYSTEM SENSITIVITY is calcul

49、ated. The test is critically dependent 9 EN 60789:2005 upon accurate assays of RADIOACTIVITY as measured in a dose calibrator or well counter. It is difficult to maintain an absolute calibration with such devices to accuracies better than 10 %. Absolute reference standards of the appropriate RADIONUCLIDE should be considered if higher degrees of accuracy are required. 4.2.4 Radionuclide The RADIONUCLIDE used for this measurement shall be appropriate for the C