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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 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/27/2008 18:31:10 MDTNo reproduction or networking permitted without license from IHS -,-,- THIS PUBLICATION IS COPYRIGHT PROTECTED
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17、mail: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/27/2008 18:31:10 MDTNo reproduction or networking permitted without license from IHS -,-,- IEC/TR 609
18、77 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 fonctionnelles
19、 INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.50 PRICE CODE CODE PRIX ISBN 2-8318-9893-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Copyright International E
20、lectrotechnical Commission Provided by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/27/2008 18:31:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 TR 60977 IEC:2008 CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.7 2 Normative references .7 3 Ge
21、neral, type tests .7 3.1 Format of Annex A of the disclosure standard with suggested functional performance 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 A
22、cceptance tests39 4.1 General.39 4.2 Summary of suggested test methods for MEDICAL ELECTRON ACCELERATOR 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 .5
23、9 5.1 Introduction .59 5.2 Suggested set of periodic test methods and test conditions.61 5.3 Suggested frequency 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 MONITORI
24、NG SYSTEM proportionality43 Table 1 Summary of major tolerances in routine X-RAY THERAPY38 Table 2 Suggested set of periodic test methods and test conditions.61 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/
25、27/2008 18:31:10 MDTNo reproduction or networking permitted without license from IHS -,-,- TR 60977 IEC:2008 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT MEDICAL ELECTRON ACCELERATORS GUIDELINES FOR FUNCTIONAL PERFORMANCE CHARACTERISTICS FOREWORD 1) The International El
26、ectrotechnical 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 standardization in the electrical and electronic field
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35、 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. IEC shall not be held responsible for identifying
36、 any or all such 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 S
37、tandard, for example “state of the 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 repla
38、ces the first edition published in 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 relative
39、ly new technologies introduced within 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 Copyright International Electrotechnical Commission Provided
40、by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/27/2008 18:31:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 TR 60977 IEC:2008 FIELDS (PWF). Also included are STEREOTACTIC RADIOTHERAPY (SRT)/STEREOTACTIC RADIOSURGERY (SRS) and the use of
41、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 report on voting indicated in the abov
42、e 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:/webstore.iec.ch“ in the data related to the
43、 specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Boeing Co/5910770001 Not for Resale, 07/27/2008 18:31:10 MDTNo reproducti
44、on or networking permitted without license from IHS -,-,- TR 60977 IEC:2008 5 INTRODUCTION The guidelines given in this report are recommendations both to manufacturers and to USERS. They provide guidance to MANUFACTURERS on the needs of USERS in respect of the performance of ELECTRON ACCELERATORS a
45、nd 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 life of the equipment. IEC 60601-11) is a general standard for the safety of medical electrical equipment.
46、 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 has been issued as a disclosure standard. It standardizes methods of declaring the MEDICAL ELECTRON ACCELE
47、RATOR functional performance characteristics. It standardizes the type test conditions and type test methods to which manufacturers declared values of functional performance relate. A format for the presentation of functional performance values is contained in IEC 60976. It is repeated herein as 3.1
48、, 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 for 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 custo