IEC 62467-1-2009 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1 Instruments based on well-type ionization chambers《医用电气设备.近距放射疗法用剂量测定仪器.第1部分 安装在井型电离室的器械》.pdf

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1、 IEC 62467-1Edition 1.0 2009-06INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Dosimetric instruments as used in brachytherapy Part 1: Instruments based on well-type ionization chambers Appareils lectromdicaux Instruments de dosimtrie utiliss en curiethrapie Partie 1: Instrum

2、ents conus pour les chambres dionisation puits IEC62467-1:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechani

3、cal, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the addre

4、ss below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photoc

5、opie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de

6、la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all ele

7、ctrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.c

8、h/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publicati

9、ons. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French, with equiv

10、alent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact

11、us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparent

12、es. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogu

13、e en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouve

14、lles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et df

15、initions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publicatio

16、n ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 62467-1Edition 1.0 2009-06INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Dosimetric instruments as used in brachytherapy Par

17、t 1: Instruments based on well-type ionization chambers Appareils lectromdicaux Instruments de dosimtrie utiliss en curiethrapie Partie 1: Instruments conus pour les chambres dionisation puits INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE TICS 11.040.50; 11.040

18、60 PRICE CODECODE PRIXISBN 2-8318-1045-1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 62467-1 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope and object7 2 Normative references .7 3 Terms and definitions .8

19、 4 General requirements.12 4.1 PERFORMANCE REQUIREMENTS.12 4.2 MEASURING ASSEMBLY 12 4.3 Source types .12 4.3.1 General .12 4.3.2 Beta particle-emitting sources .13 4.3.3 Low-energy-photon-emitting sources .13 4.4 Quantity to be measured .13 4.5 Reference and STANDARD TEST CONDITIONS 13 4.6 General

20、test conditions13 4.6.1 STANDARD TEST CONDITIONS13 4.6.2 STABILIZATION TIME .13 4.6.3 Adjustments during test .14 4.6.4 Batteries14 4.7 Constructional requirements as related to performance .14 4.7.1 General .14 4.7.2 Components 14 4.7.3 Display 14 4.7.4 Inserts .14 4.7.5 STABILIZATION TIME .14 4.8

21、Test of components.15 5 Limits of performance characteristics15 5.1 Position of source in insert and repeatability .15 5.2 USABLE LENGTH 15 5.3 RESOLUTION OF THE DISPLAY .15 5.4 STABILIZATION TIME.15 5.5 LEAKAGE CURRENT16 5.5.1 In AIR KERMA STRENGTH measuring mode16 5.5.2 In charge measuring mode 16

22、 5.6 Stability.16 5.6.1 Long term stability .16 5.6.2 MANUFACTURER method to check long term stability .16 6 LIMITS OF VARIATION for effects of influence quantities .16 6.1 General .16 6.2 IONIZATION CHAMBER recombination losses 17 6.3 Operating voltage17 6.3.1 Mains operated MEASURING ASSEMBLY 17 6

23、3.2 Battery operated MEASURING ASSEMBLY 17 6.3.3 Rechargeable MEASURING ASSEMBLY.18 6.4 Air pressure.18 6.5 Change of air pressure and EQUILIBRATION TIME of the radiation detector .18 62467-1 IEC:2009 3 6.5.1 VENTED WELL TYPE IONIZATION CHAMBERS 18 6.5.2 SEALED WELL TYPE IONIZATION CHAMBERS.19 6.6

24、Temperature and humidity.19 6.7 Length RESPONSE 19 6.8 Electromagnetic immunity20 7 Marking 20 7.1 WELL-TYPE IONIZATION CHAMBER ASSEMBLY20 7.2 MEASURING ASSEMBLY 20 8 ACCOMPANYING DOCUMENTS.20 8.1 General .20 8.2 Use of the instrument 20 8.3 Documentation 21 Bibliography22 Index of defined terms 23

25、Table 1 REFERENCE and STANDARD TEST CONDITIONS.13 Table 2 LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES.17 4 62467-1 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY Part 1: Instruments based on well-type

26、ionization chambers FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning st

27、andardization 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 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their prepar

28、ation 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 participate in this preparation. IEC collaborates closely wi

29、th 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 express, as nearly as possible, an international consensus of opinion on the relevant sub

30、jects 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 Committees in that sense. While all reasonable efforts are made to ensure that the technica

31、l 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 Committees undertake to apply IEC Publications transparently to the maximum extent

32、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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any e

33、quipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the 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 an

34、d IEC National Committees for any personal injury, property damage or 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) A

35、ttention is drawn to the Normative references cited in this publication. 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

36、 IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 62467-1 has been prepared by subcommittee 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62, Electrical equipment in medical practice.

37、The text of this standard is based on the following documents: FDIS Report on voting 62C/460/FDIS 62C/468/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the I

38、SO/IEC Directives, Part 2. 62467-1 IEC:2009 5 A list of all parts of the IEC 62467 series, published under the general title Medical electrical equipment Dosimetric instruments as used in brachytherapy, can be found on the IEC website. In this standard the following print types are used: Requirement

39、s, compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, general statements and exceptions: in small roman type; test specifications: in italic type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN THE PUBLICATIONS INDICATED IN

40、 THE INDEX OF DEFINED TERMS: IN SMALL CAPITALS. The committee has decided 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 publi

41、cation will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 62467-1 IEC:2009 INTRODUCTION The wide range of WELL-TYPE IONIZATION CHAMBER instruments currently being used for BRACHYTHERAPY sources indicates the need for a standard for uniformity in measurement and test techniq

42、ues for WELL-TYPE IONIZATION CHAMBER instruments. Measurements of the output of BRACHYTHERAPY sources have distinct requirements that differ from the assay of sources used in diagnostic nuclear medicine. This translates into the requirements for the measurement devices. Many times similar instrument

43、ation is used for both applications; however, there are tighter requirements for those instruments used for BRACHYTHERAPY sources. Such devices are composite systems consisting of an IONIZATION CHAMBER, either integrally coupled or connected to appropriate electronic circuitry that converts the ioni

44、zation current to a readout, which can be converted to a quantity appropriate to the source being measured. The ionization current produced can be either read directly or as accumulated charge (current integrated over time) and then converted manually to the appropriate quantity, AIR KERMA STRENGTH

45、REFERENCE AIR KERMA RATE) or ABSORBED DOSE TO WATER. The principles of operation of the IONIZATION CHAMBER are well known and are not repeated here. In addition, the readout device many times also has application to therapy uses and is well known. Although this standard is written using the quantit

46、y AIR KERMA STRENGTH, the principles are the same for other quantities such as REFERENCE AIR KERMA RATE. In principle the quantity measured is the dose volume integral from which under specified conditions the dose quantities AIR KERMA STRENGTH, REFERENCE AIR KERMA RATE, or ABSORBED DOSE TO WATER at

47、 a depth can be deduced. The signal produced by the chamber is the electrical current or charge, which is to be measured with an electrometer meeting criteria according to IEC 60731. The current or charge is converted to the dosimetric quantity of interest by means of a source type specific CALIBRAT

48、ION FACTOR. 62467-1 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY Part 1: Instruments based on well-type ionization chambers 1 Scope and object This part of IEC 62467 specifies the performance and some related constructional requirements of WELL-TYPE IONIZAT

49、ION CHAMBERS and associated measurement apparatus, as defined in Clause 3, intended for the determination of a quantity, such as AIR KERMA STRENGTH or REFERENCE AIR KERMA RATE in photon radiation fields or ABSORBED DOSE TO WATER at a depth, in photon and beta radiation fields used in BRACHYTHERAPY, after appropriate calibration for a given type of source. This International Standard cove

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