1、 TECHNICAL REPORT IEC TR 61948-4First edition 2006-11Nuclear medicine instrumentation Routine tests Part 4: Radionuclide calibrators Reference number IEC/TR 61948-4:2006(E) Publication numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. For exampl
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7、tion. 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 TECHNICAL REPORT IEC TR 61948-4First edition 2006-11Nuclear medicine instrument
8、ation Routine tests Part 4: Radionuclide calibrators PRICE CODE IEC 2006 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publi
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10、technical Commission 2 TR 61948-4 IEC:2006(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope and object6 2 Normative references .6 3 Terms and definitions .6 4 Test methods .8 4.1 BACKGROUND RESPONSE .8 4.2 Constancy of instrument response.8 4.3 SYSTEM LINEARITY 8 4.4 Additional checks 8 4.5 Frequency o
11、f ROUTINE TESTS8 Bibliography10 Index of defined terms 11 Table 1 Frequency of ROUTINE TESTS9 TR 61948-4 IEC:2006(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 4: Radionuclide calibrators FOREWORD 1) The International Electrotechnical Commission
12、 (IEC) is a worldwide organization for 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
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20、 other damage of any nature whatsoever, 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 publicati
21、on. Use of the referenced publications 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. The IEC shall not be held responsible for identifying any or all su
22、ch patent rights. The main task of IEC technical 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 e
23、xample “state of the art“. IEC 61948-4, 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. The text of this technical report is based on the
24、 following documents: Enquiry draft Report on voting 62C/387/DTR 62C/401/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. 4 TR 61948-4 IEC:2006(E) This publication has been drafted in accordance with the I
25、SO/IEC Directives, Part 2. In this technical report the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; explanation, advice, introductions, general statements, exceptions and reference: in smaller roman type; test specifications: in
26、italic type; TERMS DEFINED IN CLAUSE 3 OF THIS TECHNICAL REPORT OR LISTED IN THE INDEX OF DEFINED TERMS: SMALL CAPITALS. A list of all parts of the IEC 61948 series, published under the general title Nuclear medicine instrumentation Routine tests, can be found on the IEC website. The committee has d
27、ecided that the contents of this publication will remain unchanged until the maintenance result 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,
28、 or amended. A bilingual version of this publication may be issued at a later date. TR 61948-4 IEC:2006(E) 5 INTRODUCTION This technical report is based on the German Standard DIN 6855-11, Qualittsprfung nuklearmedizinischer Messsysteme Teil 11: Konstanzprfung von Aktivimetern, the English document
29、Protocol for Establishing and Maintaining the Calibration of Medical Radionuclide Calibrators and their Quality Control, the Austrian document NORM S 5270, Aktivimeter Richtlinien fr die Konstanzprfung am Verwendungsort / Radionuclide calibrators Guidelines for the constancy testing in the field / C
30、alibrateurs de radionuclides Directives pour lessai de constance lendroit dutilisation, of 1 April 1998, and the Spanish document Protocolo Nacional del Control de Calidad en la Instrumentacin en Medicina Nuclear. 6 TR 61948-4 IEC:2006(E) NUCLEAR MEDICINE INSTRUMENTATION ROUTINE TESTS Part 4: Radion
31、uclide calibrators 1 Scope and object This technical report covers the routine testing of radionuclide calibrators used in nuclear medicine. Such devices utilise ionization chambers of the well type (directly coupled to an appropriate electronic circuitry (IEC 61145) and a direct readout in units of
32、 ACTIVITY. Requirements and specific methods to determine performance parameters are described in IEC 61303 and IEC 61145. These methods are primarily designed for acceptance testing. 2 Normative references The following referenced documents are indispensable for the application of this document. Fo
33、r dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60788:2004, Medical electrical equipment Glossary of defined terms IEC 61145:1992, Calibration and usage of ionization chamber systems for
34、 assay of radionuclides IEC 61303:1994, Medical electrical equipment Radionuclide calibrators Particular methods for describing performance IEC 61948-1:2001, Nuclear medicine instrumentation Routine tests Part 1: Radiation counting systems 3 Terms and definitions For the purposes of this document, t
35、he terms and definitions given in IEC 60788:2004, IEC 61303:1994 and IEC 61145:1992, some of which are repeated here for convenience, and the following terms and definitions apply. 3.1 acceptance test test carried out at the request and with the participation of the user or his representative to asc
36、ertain by determination of proper 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 DA
37、TA are collected to be used as a standard for comparison with future ROUTINE TESTS. IEC 61948-1:2001, definition 3.2.1 3.2 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 REFE
38、RENCE DATA NOTE A ROUTINE TEST could be carried out by the user with simple methods and equipment. IEC TR 61948-1:2001, definition 3.2.2 TR 61948-4 IEC:2006(E) 7 3.3 ionization chamber test source RADIOACTIVE SOURCE used for the determination of the long-term stability of an ionization chamber. The
39、half-life of the source shall be greater than five years and the effects of any radioactive contaminants shall be such that the indication of the device over a period of five years would not deviate by more than 0,5 % after decay correction for the known half-life of the principal radionuclide IEC 6
40、1303:1994, definition 2.7 NOTE The IONIZATION CHAMBER TEST SOURCE is used to test the functionality of a radionuclide calibrator under defined conditions. 3.4 radionuclide factor factor, dependent on the radionuclide, by which the response of the system must be multiplied in order to obtain the corr
41、ect ACTIVITY reading of a source which has been placed in the ionization chamber IEC 61303:1994, definition 2.2 3.5 system linearity function relating the observed and predicted ACTIVITY values when the activity of a specified RADIOACTIVE SOURCE is varied IEC 61303:1994, definition 2.4 3.6 backgroun
42、d response reading of the instrument without intended radioactive source NOTE The BACKGROUND RESPONSE is caused by external radiation fields, but in addition also by electronic noise and contamination. 3.7 radioactive standard source general term used to refer to the standard sources listed below IE
43、C 61303:1994, definition 2.1 3.7.1 certified radioactive standard source RADIOACTIVE SOURCE that has been calibrated by a laboratory recognized as a countrys national standardizing laboratory for radioactivity measurements and has been so certified by the aforementioned laboratory IEC 61303:1994, 2.
44、1.1 3.7.2 TRACEABLE RADIOACTIVE STANDARD SOURCE RADIOACTIVE SOURCE that has been calibrated by comparing it to a CERTIFIED RADIOACTIVE STANDARD SOURCE or to another TRACEABLE RADIOACTIVE STANDARD SOURCE of the same radionuclide IEC 61303:1994, 2.1.2 3.8 reference data a set of data measured immediat
45、ely after acceptance testing, using test methods designed for routine testing IEC TR 61948-1:2001, definition 3.2.3 8 TR 61948-4 IEC:2006(E) 3.9 radionuclide calibrator device for measuring the activity of a radioactive sample IEC TR 61303:1994, definition 2.11 4 Test methods 4.1 BACKGROUND RESPONSE
46、 The BACKGROUND RESPONSE shall be obtained with the setting that corresponds to the most often used nuclide. The measurement should be made with the sample holder in place. 4.2 Constancy of instrument response The constancy of instrument response of the radionuclide calibrator and, hence, its calibr
47、ation shall be obtained for a specified radionuclide setting by inserting the IONIZATION CHAMBER TEST SOURCE into the measurement position. The instrument reading shall be compared to the REFERENCE DATA. 4.3 SYSTEM LINEARITY 4.3.1 General The test of SYSTEM LINEARITY shall cover all the range of ACT
48、IVITY used in the facility. The sample of the radionuclide used shall be introduced into the measuring position of the device under test. The ACTIVITY shall be measured so that at least one data point is measured per decade of the instrument scale. 4.3.2 Decaying source method SYSTEM LINEARITY is te
49、sted using the radioactive decay of a sample of a short-lived radionuclide, e.g. 99m Tc. The time intervals between the individual measurements shall be so chosen that at least one data point is measured per decade of the instrument scale. 4.3.3 Data analysis Applying a mono-exponential fit to the measured data in the range 1 MBq and the 80 % of the highest activity used, the ratio of th
