EN 62467-1-2015 en Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1 Instruments based on well-type ionization chambers.pdf

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1、BSI Standards PublicationMedical electrical equipment Dosimetric instruments as used in brachytherapyPart 1: Instruments based on well-type ionization chambersBS EN 62467-1:2015National forewordThis British Standard is the UK implementation of EN 62467-1:2015. It is identical to IEC 62467-1:2009.The

2、 UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine andradiation dosimetry.A list of organizations represented on this committee can be obtained onrequest to its

3、 secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 57216 6ICS 11.040.50; 11.040.60Compliance with a British

4、Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 62467-1:2015EUROPEAN STANDARD NORME EU

5、ROPENNE EUROPISCHE NORM EN 62467-1 October 2015 ICS 11.040.50; 11.040.60 English Version Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers (IEC 62467-1:2009) Appareils lectromdicaux - Instruments de dosimtrie u

6、tiliss en curiethrapie - Partie 1: Instruments conus pour les chambres dionisation puits (IEC 62467-1:2009) Medizinische elektrische Gerte - Dosimetriegerte zur Anwendung in der Brachytherapie - Teil 1: Messgerte mit Schachtionisationskammern (IEC 62467-1:2009) This European Standard was approved by

7、 CENELEC on 2015-09-15. CENELEC members are bound to comply 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 st

8、andards may be obtained on application to the CEN-CENELEC Management Centre 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 lang

9、uage and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fran

10、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Nor

11、malisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 62467-1:2015 E BS EN 62467-1:2015EN 6

12、2467-1:2015 2 European foreword The text of document 62C/460/FDIS, future edition 1 of IEC 62467-1, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and ap

13、proved by CENELEC as EN 62467-1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-06-15 latest date by which the national standards conflicting with the document

14、 have to be withdrawn (dow) 2018-09-15 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate

15、 given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the Int

16、ernational Standard IEC 62467-1:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1-3:2008 NOTE Harmonized as EN 60601-1-3:2008 (not modified). IEC 61010

17、-1 NOTE Harmonized as EN 61010-1. IEC 61676:2002 NOTE Harmonized as EN 61676:2002 (not modified). BS EN 62467-1:2015EN 62467-1:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, a

18、re 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. NOTE 1 When an International Publication has been modi

19、fied by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Publication Year Title EN/HD Year IEC 60050-393 2003 International Electrotechnical Voc

20、abulary - Part 393: Nuclear instrumentation - Physical phenomena and basic concepts - - IEC 60417 - Graphical symbols for use on equipment - - IEC 60580 2000 Medical electrical equipment - Dose area product meters EN 60580 2000 IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirem

21、ents for basic safety and essential performance EN 60601-1 2006 - - + corrigendum Mar. 2010 - - + A12 2014 IEC 60731 1997 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy - - IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC

22、61187 - Electrical and electronic measuring equipment - Documentation EN 61187 - IEC 61674 1997 Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging EN 61674 1997 ISO/IEC Guide 99 2007 International vocabulary of metro

23、logy - Basic and general concepts and associated terms (VIM) - - BS EN 62467-1:2015EN 62467-1:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free T

24、rade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Direct

25、ive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 62467-1:2015 2 62467-1 IEC:2009CONTENTSFOREWORD.4INTRODUCTION.61Scope and object72Normative references.73Terms and definitions.84General requirements.124

26、.1PERFORMANCE REQUIREMENTS .124.2MEASURING ASSEMBLY 124.3Source types.124.3.1General.124.3.2Beta particle-emitting sources.134.3.3Low-energy-photon-emitting sources.134.4Quantity to bemeasured.134.5Reference and STANDARD TEST CONDITIONS 134.6General test conditions134.6.1STANDARD TEST CONDITIONS 134

27、.6.2STABILIZATION TIME .134.6.3Adjustments during test.144.6.4Batteries144.7Constructional requirements as related to performance.144.7.1General.144.7.2Components144.7.3Display144.7.4Inserts.144.7.5STABILIZATION TIME .144.8Test of components.155Limitsof performance characteristics155.1Positionofsour

28、ce in insert andrepeatability.155.2USABLE LENGTH155.3RESOLUTION OF THE DISPLAY.155.4STABILIZATION TIME .155.5LEAKAGE CURRENT165.5.1In AIR KERMA STRENGTH measuring mode165.5.2In charge measuring mode165.6Stability.165.6.1Long term stability.165.6.2MANUFACTURER method to check longterm stability.166LI

29、MITS OF VARIATION foreffects of influence quantities.166.1General.166.2IONIZATION CHAMBER recombination losses176.3Operating voltage176.3.1Mains operated MEASURING ASSEMBLY 176.3.2Battery operated MEASURING ASSEMBLY 176.3.3Rechargeable MEASURING ASSEMBLY .186.4Air pressure.186.5Change of air pressur

30、e and EQUILIBRATION TIME of the radiationdetector.18BS EN 62467-1:201562467-1 IEC:2009 3 6.5.1VENTEDWELL TYPE IONIZATION CHAMBERS 186.5.2SEALED WELL TYPE IONIZATION CHAMBERS .196.6Temperature and humidity.196.7Length RESPONSE 196.8Electromagnetic immunity207Marking207.1WELL - TYPE IONIZATION CHAMBER

31、 ASSEMBLY 207.2MEASURING ASSEMBLY 208ACCOMPANYING DOCUMENTS.208.1General.208.2Use of the instrument208.3Documentation21Bibliography22Indexof defined terms23Table 1 R EFERENCE and STANDARD TEST CONDITIONS.13Table 2 L IMITS OF VARIATION for the effectsof INFLUENCE QUANTITIES.17BS EN 62467-1:2015 4 624

32、67-1 IEC:2009INTERNATIONAL ELECTROTECHNICAL COMMISSION_ MEDICAL ELECTRICAL EQUIPMENT DOSIMETRIC INSTRUMENTS ASUSED IN BRACHYTHERAPY Part 1: Instruments based on well-type ionization chambersFOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardizatio

33、n comprisingall national electrotechnicalcommittees (IEC National Committees). The object of IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, IEC publishes International St

34、andards, Technical Specifications,TechnicalReports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IECPublication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interestedin the subject dealtwith may participate in thispreparat

35、ory work. International,governmental and non-governmental organizations liaising with the IEC also participate in thispreparation. IEC collaborates closelywith the International Organization for Standardization (ISO) in accordance with conditions determined byagreement between the two organizations.

36、2) The formal decisions or agreements of IEC on technical matters express, as nearlyas possible, an internationalconsensus of opinion on the relevant subjects since each technical committee has representation from allinterested IEC National Committees. 3) IEC Publications have the form of recommenda

37、tions for international use and are accepted by IEC NationalCommittees in that sense. While all reasonable efforts are made to ensure that the technical content of IECPublications is accurate, IEC cannot be held responsible for t he way in which theyare used or for anymisinterpretation by any end us

38、er.4) In order to promote international uniformity, IEC NationalCommittees undertake to apply IEC Publicationstransparently to the maximum extent possible in their national and regional publications. Any divergencebetween any IEC Publication and the corresponding national or regional publication sha

39、ll be clearly indicated inthe latter.5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformitywith an IEC Publication.6) All users should ensure that they have the latest edition of this publication.7) No liability

40、shall attach to IEC or its directors, employees, servants or agents including individual experts andmembers of its technical committees and IEC National Committees for any personal injury, property damage orother damage of any nature whatsoever, whether direct or indirect, or for costs (including le

41、gal fees) and expenses arising out of the publication, use of,or reliance upon, this IEC Publication or any other IECPublications.8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications isindispensable for the correct application of this public

42、ation.9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject ofpatent rights. IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 62467-1 has been prepared bysubcommittee62C, Equipmentforrad

43、iotherapy, nuclearmedicine andradiation dosimetry, of IEC technical committee 62,Electrical equipment in medical practice. The text ofthisstandard is based on the following documents:FDIS Report on voting62C/460/FDIS 62C/468/RVD Full information on the voting for the approval of this standard can be

44、 found in the report onvoting indicated in the above table.This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.BS EN 62467-1:201562467-1 IEC:2009 5 A list of all parts of the IEC62 467 series, published under t he general title Medical electricalequipment Dosimetric i

45、nstruments as used in brachytherapy, can be found on the IEC website. In this standard the following print types are used: Requirements,compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, general statements and exceptions: in small roman type;testspecifi

46、cations: in italic type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN C LAUSE 3 OR IN THEPUBLICATIONS INDICATED IN THE INDEX OF DEFINED TERMS: IN SMALL CAPITALS . The committee has decided that the contents of this publication will remain unchanged untilthe maintenance result date i

47、ndicated on the IEC web site under “http:/webstore.iec.ch“ inthe data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replacedbya revised edition, or amended. BS EN 62467-1:2015 6 62467-1 IEC:2009INTRODUCTION Thewide range of WELL- TYPE IONIZATION C

48、HAMBER instrumentscurrently being used forBRACHYTHERAPY sourcesindicates the need for a standard for uniformity in measurement and test techniques for WELL- TYPE IONIZATIONCHAMBER instruments. Measurements ofthe output ofBRACHYTHERAPY sources have distinct requirements that differ from the assay of

49、sources usedin diagnostic nuclear medicine. This translatesinto the requirements for the measurement devices. Many times similar instrumentation is used for both applications; however, there aretighter requirements for those instruments used for BRACHYTHERAPY sources. Such devicesare composite systemsconsist ing of an IONIZATION CHAMBER, either integrally coupled orconnected to appropriate electronic c ircuitry that convertsthe ionization current t o a readout, which can be converted to a quant