BS PD IEC TR 61948-1-2016 Nuclear medicine instrumentation Routine tests Gamma radiation counting system《核医疗设备 常规试验 第1部分 伽玛辐射计数系统》.pdf

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1、BSI Standards Publication Nuclear medicine instrumentation Routine tests Part 1: Gamma radiation counting system PD IEC/TR 61948-1:2016National foreword This Published Document is the UK implementation of IEC/TR 61948-1:2016. It supersedes PD IEC/TR 61948-1:2001 which is withdrawn. The UK participat

2、ion in its preparation was entrusted by Technical Committee 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 be obtained on request to its secretar

3、y. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 91375 4 ICS 11.040.50 Compliance with a British Standard canno

4、t confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 April 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 61948-1:2016 IEC TR 61948-1 Edition 2.0

5、2016-03 TECHNICAL REPORT Nuclear medicine instrumentation Routine tests Part 1: Gamma radiation counting system INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.50 ISBN 978-2-8322-3240-8 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained th

6、is publication from an authorized distributor. PD IEC/TR 61948-1:2016 2 IEC TR 61948-1:2016 IEC 2016 CONTENTS FOREWORD . 3 1 Scope 5 2 Normative references. 5 3 Terms and definitions 5 4 Test methods . 6 4.1 General . 6 4.2 Background check . 6 4.3 ENERGY CALIBRATION 7 4.4 ENERGY CALIBRATION lineari

7、ty . 7 4.5 Constancy of sensitivity . 7 4.6 Constancy of ENERGY RESOLUTION 7 4.7 Counting precision 7 5 Frequency of ROUTINE TESTS 8 Annex A (informative) Index of defined terms . 9 Table 1 Frequency of ROUTINE TESTS 8 PD IEC/TR 61948-1:2016IEC TR 61948-1:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNIC

8、AL COMMISSION _ NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 1: Gamma radiation counting system FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The ob

9、ject 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 activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specificat

10、ions (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 dealt with may participate in this preparatory work. International, governmental and non- governmental organizations lia

11、ising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters expre

12、ss, 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. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committ

13、ees 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 are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National

14、 Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not

15、 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 responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have th

16、e 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 committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever

17、, 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 Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications

18、 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 patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC tec

19、hnical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC TR 61948-1,

20、 which is a technical report, has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2001. This editi

21、on constitutes a technical revision and includes the following significant technical changes with respect to the previous edition: a) Geiger-Mueller counters are explicitly excluded from the scope; PD IEC/TR 61948-1:2016 4 IEC TR 61948-1:2016 IEC 2016 b) the routine test for energy calibration has b

22、een split into a test for energy calibration (frequency: daily) and a test for energy calibration linearity (frequency: semi-annual); c) the test for window presets has been removed. The text of this technical report is based on the following documents: Enquiry draft Report on voting 62C/621/DTR 62C

23、/642/RVC Full information on the voting for the approval of this technical report 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 technical report the following print types are used: requi

24、rements, compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, introductions, general statements, exceptions and references: in smaller roman type; test specifications: in italic type; TERMS DEFINED IN CLAUSE 3 OF THIS TECHNICAL REPORT OR LISTED IN ANNEX A

25、: SMALL CAPITALS. The requirements are followed by specifications for the relevant tests. A list of all parts in the IEC 61948, published under the general title Nuclear medicine instrumentation Routine tests, can be found on the IEC website. The committee has decided that the contents of this publi

26、cation will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.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. A bilingual version of this publ

27、ication may be issued at a later date. PD IEC/TR 61948-1:2016IEC TR 61948-1:2016 IEC 2016 5 NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 1: Gamma radiation counting system 1 Scope This part of IEC 61948, which is a technical report, describes test methods of instruments that count and measure

28、 the energy of photons emitted by RADIONUCLIDES in vivo and in vitro without the option of imaging. This includes, for example, well counters and organ probes. Geiger-Mueller counters and dose calibrators are not within the scope of this document. As part of QUALITY CONTROL this report is defining R

29、OUTINE TESTS to be performed by the user of gamma radiation counting systems to maintain proper operation conditions. The results of these ROUTINE TESTS are compared to the REFERENCE DATA determined during or after the ACCEPTANCE TEST. 2 Normative references The following documents, in whole or in p

30、art, 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. IEC TR 60788:2004, Medical electrical equipment

31、Glossary of defined terms 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC TR 60788, as well as the following definitions apply (see Annex A). NOTE Defined terms are printed in small capital letters. 3.1 acceptance test test carried out after new EQUI

32、PMENT has been installed, or major modifications have been made to existing EQUIPMENT, in order to verify compliance with contractual specifications Note 1 to entry: During or immediately after ACCEPTANCE TEST, REFERENCE DATA are collected to be used as a standard for comparison with future ROUTINE

33、TESTS. SOURCE: IEC TR 60788:2004, rm-70-01, modified addition a new Note to entry. 3.2 activity A quantitative indication of the radioactivity of an amount of RADIONUCLIDE in a particular energy state at a given time. ACTIVITY is determined as the quotient of dN by dt, where dN is the expectation va

34、lue of the number of spontaneous nuclear transitions from that energy state in the time interval dt: t N A d d = PD IEC/TR 61948-1:2016 6 IEC TR 61948-1:2016 IEC 2016 The unit of ACTIVITY is the reciprocal second (s 1 ). The special name of the unit of ACTIVITY is the Becquerel (Bq), 1 Bq being equa

35、l to one transition per second. The earlier unit of ACTIVITY was the curie (Ci), 1 Ci being equal to 3,7 10 10 transitions per second. SOURCE: IEC TR 60788:2004, rm-13-18 3.3 energy calibration process of establishing a relation between the window setting of the pulse height analyser and the energy

36、of the photons 3.4 energy resolution term used to characterize the ability of a radiation detector to distinguish between photons of different energies Note 1 to entry: The ENERGY RESOLUTION can be expressed as the ratio of the photopeak full width at half maximum (FWHM) to photopeak energy expresse

37、d as a percentage. 3.5 quality control part of the quality assurance including tests of instruments with appropriate test methods Note 1 to entry: Includes both ACCEPTANCE test and ROUTINE TEST. 3.6 radionuclide radioactive nuclide SOURCE: IEC TR 60788:2004, rm-11-22 3.7 reference data set of data m

38、easured immediately after ACCEPTANCE TEST, using test methods designed for ROUTINE TEST 3.8 routine test test of a piece of equipment or its components which is repeated at specified intervals, to establish and document changes from the initial status described by REFERENCE DATA Note 1 to entry: A R

39、OUTINE TEST could be carried out by the user with simple methods and equipment. 4 Test methods 4.1 General ROUTINE TESTS include tests with and without radioactive sources. If radioactive test sources are used, the count losses ideally do not exceed 5 %. 4.2 Background check The background count rat

40、e is determined for each energy and window setting commonly used. This report includes the background count rate for each energy and window setting used. PD IEC/TR 61948-1:2016IEC TR 61948-1:2016 IEC 2016 7 4.3 ENERGY CALIBRATION The ENERGY CALIBRATION test checks the relationship between the window

41、 setting of the pulse height analyser and the energy of the photons. A RADIONUCLIDE with gamma energy appropriate for the energy range used is selected and used as a reference point. The position of the centre of the photopeak matches the corresponding gamma energy of the RADIONUCLIDE. This report i

42、ncludes the gamma energy of the RADIONUCLIDE used and the position of the photopeak. 4.4 ENERGY CALIBRATION linearity To test the linearity of the ENERGY CALIBRATION over the entire energy range used for clinical studies, the centre lines of the photopeaks of RADIONUCLIDES with different photon ener

43、gies are determined using the calibration setting for the reference point (see 4.3). At least RADIONUCLIDES with three different photon energies covering the energy range are used. This report includes the gamma energy for every RADIONUCLIDE used and the corresponding position for each photopeak tes

44、ted. NOTE If only one RADIONUCLIDE is used, the setting of the reference point is valid for this nuclide. 4.5 Constancy of sensitivity Sensitivity is tested with a reference source containing a long-lived RADIONUCLIDE of appropriate photon energy. The RADIONUCLIDE, measurement geometry, and function

45、al settings of the instrument are fixed. Background correction is applied. This report includes the identity and ACTIVITY of the test source, the count rate per unit of ACTIVITY, the measurement geometry, and instrument settings. 4.6 Constancy of ENERGY RESOLUTION The RADIONUCLIDE, measurement geome

46、try, and functional settings of the instrument are fixed. The pulse height spectrum is obtained with a channel width less than or equal to 20 % of the expected photopeak FWHM. The recommended number of counts in the peak channel is greater than 10 000. The photopeak full width at half maximum (FWHM)

47、 is calculated. This report includes the FWHM, the RADIONUCLIDE, the gamma energy, the measurement geometry, and instrument settings. 4.7 Counting precision For testing the counting precision the chi-square test is used. Ten or more counting measurements are performed. For each measurement N i and a

48、 preset time interval, about 10 000 counts are collected. For a set of n observed count values (N i ) in a preset time interval, a mean value ( N ) can be calculated. The value of chi-square can be calculated by ( ) N N N n i = ) 1 ( 2 i 2 (1) PD IEC/TR 61948-1:2016 8 IEC TR 61948-1:2016 IEC 2016 Fo

49、r example, for 10 measurements, the value for chi-square is expected to be 9 , 16 3 , 3 2 (2) This report includes the value of the chi-square. 5 Frequency of ROUTINE TESTS The typical frequencies of ROUTINE TESTS are given in Table 1. Table 1 Frequency of ROUTINE TESTS Test Frequency Background check Daily* ENERGY CALIBRATION Daily* Constancy of sensitivity Daily* ENERGY CALIBRATION linearity Twice per year Constancy of ENERGY RESOLUTION Twice per year Counting preci