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1、TECHNICAL REPORT IEC TR 61948-1 First edition 2001-02 Nuclear medicine instrumentation Routine tests Part 1: Radiation counting systems Instrumentation en mdecine nuclaire Essais de routine Partie 1: Systmes compteurs de rayonnement Reference number IEC/TR 61948-1:2001(E) Copyright International Ele
2、ctrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,- Publication numbering As from 1 January 1997 all IEC publications are
3、issued with a designation in the 60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publ
4、ication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to
5、 this publication, including its validity, is available in the IEC Catalogue of publications (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publicat
6、ion, as well as the list of publications issued, is also available from the following: IEC Web Site (www.iec.ch) Catalogue of IEC publications The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables you to search by a variety of criteria including text searches, technical committe
7、es and date of publication. On-line information is also available on recently issued publications, withdrawn and replaced publications, as well as corrigenda. IEC Just Published This summary of recently issued publications (www.iec.ch/JP.htm) is also available by email. Please contact the Customer S
8、ervice Centre (see below) for further information. Customer Service Centre If you have any questions regarding this publication or need further assistance, please contact the Customer Service Centre: Email: custserviec.ch Tel: +41 22 919 02 11 Fax: +41 22 919 03 00 Copyright International Electrotec
9、hnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,- TECHNICAL REPORT IEC TR 61948-1 First edition 2001-02 Nuclear medicine instru
10、mentation Routine tests Part 1: Radiation counting systems Instrumentation en mdecine nuclaire Essais de routine Partie 1: Systmes compteurs de rayonnement PRICE CODE IEC 2001 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, elect
11、ronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission3, rue de Varemb Geneva, Switzerland Telefax: +41 22 919 0300e-mail: inmailiec.ch IEC web site http:/www.iec.ch E For price, see current catalogue Com
12、mission Electrotechnique Internationale International Electrotechnical Commission Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking pe
13、rmitted without license from IHS -,-,- 2 TR 61948-1 IEC:2001(E) CONTENTS Page FOREWORD 3 Clause 1Scope and object . 5 2Reference documents 5 3Terminology and definitions . 5 4Test methods. 7 4.1ENERGY CALIBRATION. 7 4.2Sensitivity check. 8 4.3Preset window setting. 8 4.4ENERGY RESOLUTION 8 4.5COUNTI
14、NG PRECISION 8 4.6Background 8 4.7Frequency of ROUTINE TESTS. 8 Annex A Index of defined terms . 10 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproductio
15、n or networking permitted without license from IHS -,-,- TR 61948-1 IEC:2001(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 1: Radiation counting systems FOREWORD 1)The IEC (International Electrotechnical Commission) is a worldwide organization f
16、or standardization comprising all national electrotechnical committees (IEC National Committees). The object of the 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, the I
17、EC publishes International Standards. 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 liaising with the IEC also participat
18、e in this preparation. The 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 the IEC on technical matters express, as nearly as possible,
19、an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees. 3)The documents produced have the form of recommendations for international use and are published in the form of standards, technical specificatio
20、ns, technical reports or guides and they are accepted by the National Committees in that sense. 4)In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standard
21、s. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. 5)The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its
22、standards. 6) Attention is drawn to the possibility that some of the elements of this technical report may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Stand
23、ards. 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 61948-1, which is a technical report, has been prepared by sub
24、committee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. The text of this technical report is based on the following documents: Enquiry draftReport on voting 62C/255/CDV62C/265A/RVC Full information
25、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 3. Copyright International Electrotechnical Commission Provided by IHS under license with IECLi
26、censee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,- 4 TR 61948-1 IEC:2001(E) In this technical report the following print types are used: requirements, compliance with which can be tested
27、, 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: SMALL CAPITALS. The requirements are follo
28、wed by specifications for the relevant tests. The committee has decided that the contents of this publication will remain unchanged until 2005. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. This document, which is purely informative, is not
29、to be regarded as an International Standard. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,
30、- TR 61948-1 IEC:2001(E) 5 NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 1: Radiation counting systems 1 Scope and object This technical report describes test methods of counting instruments for measuring RADIONUCLIDES in vivo and in vitro without the option of imaging. ACTIVITY meters (dose c
31、alibrators) are excluded. 2 Reference documents IEC 60788:1984, Medical radiology Terminology IEC 61145:1992, Calibration and usage of ionization chamber systems for assay of radionuclides IEC 61303:1994, Medical electrical equipment Radionuclide calibrators Particular methods for describing perform
32、ance 3 Terminology and definitions For the purposes of this part of IEC 61948, the definitions given in IEC 60788, IEC 61303 and IEC 61145 and the following definitions apply (see annex A). Defined terms are printed in small capital letters. 3.1 QUALITY CONTROL part of the quality assurance in nucle
33、ar medicine including tests of instruments with appropriate test methods NOTE Includes both ACCEPTANCE TESTING and ROUTINE TESTING. 3.2 Methodology 3.2.1 ACCEPTANCE TEST test carried out at the request and with the participation of the user or his representative to ascertain by determination of prop
34、er performance parameters that the instrument meets the specifications claimed by the vendor NOTE AN ACCEPTANCE TEST should be carried out at the time of installation and when appropriate after major service. During or immediately after ACCEPTANCE TESTING, REFERENCE DATA are collected to be used as
35、a standard for comparison with future ROUTINE TESTS. 3.2.2 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 A ROUTINE TEST could be carried out by the user
36、with simple methods and equipment. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 TR 619
37、48-1 IEC:2001(E) 3.2.3 REFERENCE DATA a set of data measured immediately after ACCEPTANCE TESTING, using test methods designed for ROUTINE TESTING 3.3 IN VIVO COUNTING SYSTEM instruments designed to directly measure the ACTIVITY of radioactive substances in the body 3.3.1 ORGAN COUNTING SYSTEM instr
38、ument used for radiation detection of incorporated radioactive substances in specific organs or regions of the body 3.3.2 WHOLEBODY COUNTER instrument for estimating the amount of RADIONUCLIDES in the body and, if possible, identifying the RADIONUCLIDES and estimating the spatial distribution of RAD
39、IONUCLIDES and their ACTIVITIEs within the body. WHOLEBODY COUNTERS have a high sensitivity that is essentially independent of the distribution of ACTIVITY in the body. For minimizing the detection threshold, appropriate shielding of background radiation is necessary. 3.4 IN VITRO COUNTING SYSTEM in
40、strument designed to estimate the ACTIVITY of radioactive substances in a sample NOTE IN VITRO COUNTING SYSTEMS are usually equipped with a scintillation or semi-conductor detector. 3.4.1 WELL-TYPE DETECTOR in vitro measuring instrument utilizing a detector with a well to detect photons from a sampl
41、e inserted into the well of the detector 3.4.1.1 WELL-COUNTER instrument utilizing nearly 4 geometry counting with a WELL-TYPE DETECTOR into which the sample can be inserted 3.4.1.2 SAMPLE CHANGER counting system with a WELL-TYPE DETECTOR and a mechanism for automatically changing samples in the wel
42、l of the detector 3.4.1.3 MULTI-DETECTOR COUNTER instrument consisting of an array of WELL-TYPE DETECTORS to determine the ACTIVITY in multiple samples simultaneously 3.4.2 LIQUID SCINTILLATION COUNTER counting system utilizing a liquid scintillator in which the radioactive material is distributed N
43、OTE Usually the LIQUID SCINTILLATION COUNTER is used for measuring samples with -emitting RADIONUCLIDES. 3.4.3 CERENKOV COUNTER counting system which detects the Cerenkov radiation emitted from the sample Copyright International Electrotechnical Commission Provided by IHS under license with IECLicen
44、see=IHS Employees/1111111001, User=listmgr, listmgr Not for Resale, 03/05/2007 21:43:45 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61948-1 IEC:2001(E) 7 NOTE CERENKOV COUNTERS are used for measuring samples with -emitting RADIONUCLIDES that have a particle energy la
45、rger than the Cerenkov threshold. Under special conditions, a LIQUID SCINTILLATION COUNTER can be used as a CERENKOV COUNTER. 3.5 ENERGY CALIBRATION process of establishing a relation between the window setting of the pulse height analyzer and the energy of the photons 3.6 ENERGY RESOLUTION a term u
46、sed to characterize the ability of a radiation detector to distinguish between photons of different energies NOTE The ENERGY RESOLUTION can be expressed as the ratio of the photopeak full width at half maximum (FWHM) to photopeak energy expressed as a percentage. 3.7 RADIONUCLIDE radioactive nuclide
47、 IEC 60788 3.8 ACTIVITY Letter symbol: 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 value of the number of spontaneous nuclear transitions from
48、 that energy state in the time interval dt: t N A d d = The unit of ACTIVITY is the reciprocal second (s1). The special name of the unit of ACTIVITY is the becquerel (Bq), 1 Bq being equal to one transition per second. The earlier unit of ACTIVITY was the curie (Ci), 1 Ci being equal to 3,7 1010 transitions per second IEC 60788. 4 Test methods ROUTINE TESTING includes tests with and without radioactive sources. If radioactive test sources are used,