IEC TR 60977-2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics《医用电气设备.医用电子加速器.功能特性指南》.pdf

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1、 IEC/TR 60977 Edition 2.0 2008-07 TECHNICAL REPORT RAPPORT TECHNIQUE Medical electrical equipment Medical electron accelerators Guidelines for functional performance characteristics Appareils lectromdicaux Acclrateurs mdicaux dlectrons Lignes directrices pour les caractristiques des performances fon

2、ctionnelles IEC/TR 60977:2008 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 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 mechanical, including photocopying and m

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16、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/TR 60977 Edition 2.0 2008-07 TECHNICAL REPORT RAPPORT TECHNIQUE Medical electrical equipment Medical electron accelerators Guidelines for functional performance characteristics Appar

17、eils lectromdicaux Acclrateurs mdicaux dlectrons Lignes directrices pour les caractristiques des performances fonctionnelles INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.50 PRICE CODE CODE PRIX ISBN 2-8318-9893-5 Registered trademark of the Inter

18、national Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 TR 60977 IEC:2008 CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.7 2 Normative references .7 3 General, type tests .7 3.1 Format of Annex A of the disclosure standard with suggested functional performanc

19、e values.7 3.2 Rationale for functional performance values suggested by the Working Group30 3.2.1 Introduction .30 3.2.2 IEC 60976, Clause 630 3.2.3 Suggested functional performance values30 4 Acceptance tests 39 4.1 General .39 4.2 Summary of suggested test methods for MEDICAL ELECTRON ACCELERATOR

20、acceptance41 4.3 Acceptance test conditions50 4.4 Suggested equipment for acceptance tests and for subsequent periodic tests.59 4.4.1 Introduction .59 4.4.2 Item description.59 5 Periodic tests .59 5.1 Introduction .59 5.2 Suggested set of periodic test methods and test conditions.61 5.3 Suggested f

21、requency for periodic tests during working life of the ELECTRON ACCELERATOR.66 Bibliography68 Figure 1 Cumulative errors in beam displacement39 Figure 2 Phantom position .41 Figure 3 DOSE MONITORING SYSTEM proportionality43 Table 1 Summary of major tolerances in routine X-RAY THERAPY 38 Table 2 Sugg

22、ested set of periodic test methods and test conditions.61 TR 60977 IEC:2008 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT MEDICAL ELECTRON ACCELERATORS GUIDELINES FOR FUNCTIONAL PERFORMANCE CHARACTERISTICS FOREWORD 1) The International Electrotechnical Commission (IEC) i

23、s 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 standardization in the electrical and electronic fields. To this end and in addition to

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29、 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 equipment declared to be in conformity with an IEC Publication. 6) All users should e

30、nsure 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 and IEC National Committees for any personal injury, property damage or other damage o

31、f 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 publication. Use of the

32、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. IEC shall not be held responsible for identifying any or all such patent rights. T

33、he 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 example “state of th

34、e art“. IEC 60977, 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 i

35、n 1989 and its Amendment 1 (2000). It constitutes a technical revision. This second edition likewise follows on the issue of a second edition to the disclosure standard IEC 60976 in 2007. It includes the addition of performance guidelines relating to several relatively new technologies introduced wi

36、thin the last few years, including dynamic beam delivery techniques, such as moving beam radiotherapy, INTENSITY MODULATED RADIATION THERAPY (IMRT), IMAGE GUIDED RADIOTHERAPY (IGRT), and PROGRAMMABLE WEDGE 4 TR 60977 IEC:2008 FIELDS (PWF). Also included are STEREOTACTIC RADIOTHERAPY (SRT)/STEREOTACT

37、IC RADIOSURGERY (SRS) and the use of certain ELECTRONIC IMAGING DEVICES (EIDs). The text of this technical report is based on the following documents: Enquiry draft Report on voting 62C/424/DTR 62C/439/RVC Full information on the voting for the approval of this technical report can be found in the r

38、eport on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 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:/websto

39、re.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. TR 60977 IEC:2008 5 INTRODUCTION The guidelines given in this report are recommendations both to manufacturers and to USERS. They provi

40、de guidance to MANUFACTURERS on the needs of USERS in respect of the performance of ELECTRON ACCELERATORS and they provide guidance to USERS wishing to check the manufacturers declared performance characteristics, to carry out acceptance tests and to check periodically the performance throughout the

41、 life of the equipment. IEC 60601-1 1)is a general standard for the safety of medical electrical equipment. It is supplemented by IEC 60601-2-1, a standard which lays down particular requirements for MEDICAL ELECTRON ACCELERATORS in the range of 1 MeV to 50 MeV. In addition, IEC 60976 second edition

42、 has been issued as a disclosure standard. It standardizes methods of declaring the MEDICAL ELECTRON ACCELERATOR functional performance characteristics. It standardizes the type test conditions and type test methods to which manufacturers declared values of functional performance relate. A format fo

43、r the presentation of functional performance values is contained in IEC 60976. It is repeated herein as 3.1, with the addition of a set of suggested values which reflects the need for precision in RADIOTHERAPY and the knowledge of what is reliably achievable technically. A corresponding rationale fo

44、r the suggested values is presented in 3.2. In order to check whether each individual machine at the time of installation performs in a manner consistent with the set of functional performance values declared by the manufacturer based upon his type test data, it is customary to perform a series of a

45、cceptance tests at the USERs site before the machine is put into full medical use. Because of limitations of time and test equipment, this series of acceptance tests is usually less extensive than the type tests specified in the disclosure standard, IEC 60976. Subclause 4.2 contains a summary of sug

46、gested test methods for machine acceptance. These are consistent with the test methods of IEC 60976 but have been presented in a form which may be more suitable for use in hospitals. For reasons of economy and time, the USER may prefer to have a more limited but still standardized test performed at

47、the time of installation of the equipment. Subclause 4.3 contains a set of suggested acceptance (commissioning) test conditions. It should be emphasized that these test conditions are presented only as examples and that a quite different set of test conditions may still be needed for the purpose of

48、displaying the functional performance characteristics of the individual machine. During the working life of the MEDICAL ELECTRON ACCELERATOR, periodic tests are usually conducted by the USER to check whether the functional performance of the machine is satisfactory. Because the available machine tim

49、e is limited, a highly abbreviated set of test conditions is essential. Individual tests should not be repeated any more or less frequently than can be justified by experience with the particular machine or machine type. A set of suggested periodic test methods is presented in 5.2 and a list of suggested periodic tests during the working life of the MEDICAL ELECTRON ACCELERATOR and suggested intervals between