1、 IEC 60601-2-11 Edition 3.0 2013-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment Appareils lectromdicaux Partie 2-11: Exigences particulires pour la scurit de
2、 base et les performances essentielles des appareils de gammathrapie IEC60601-2-11:2013 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 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 mea
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16、ions contactez-nous: csciec.ch. IEC 60601-2-11 Edition 3.0 2013-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment Appareils lectromdicaux Partie 2-11: Exigences
17、 particulires pour la scurit de base et les performances essentielles des appareils de gammathrapie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE X ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-83220-584-6 Registered trademark of the International Electrotechni
18、cal Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-11 IEC:2013 CONTENTS FOREWORD
19、. 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 Normative references 7 201.2Terms and definitions 8 201.3General requirements 11 201.4General requirements for testing of ME EQUIPMENT . 12 201.5Classification of ME EQUIPMENT and ME SYSTEMS 12 201.6ME EQUIPMENT identification, marki
20、ng and documents 13 201.7Protection against electrical HAZARDS from ME EQUIPMENT 18 201.8Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 18 201.9Protection against unwanted and excessive radiation HAZARDS 20 201.10 Protection against excessive temperatures and other HAZARDS 38 2
21、01.11Accuracy of controls and instruments and protection against hazardous 201.12outputs 39 HAZARDOUS SITUATIONS and fault conditions . 39 201.13201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTESM (PEMS) . 39 Construction of ME EQUIPMENT . 40 201.15ME SYSTEMS 40 201.16Electromagnetic compatibility of ME
22、EQUIPMENT and ME SYSTEMS . 40 201.17Annexes . 45 Annex B (informative) Sequence of testing 45 Index of defined terms used in this particular standard 46 Figure 201.101 Leakage radiation 40 Figure 201.102 Points for the measurement of average leakage 42 Figure 201.103 Test plane orthogonal to the RAD
23、IATION BEAM AXIS at the NORMAL TREATMENT DISTANCE . 43 Figure 201.104 Location of test points for SITE TEST of item 201.10.2.5.2.2 43 Figure 201.105 Matrix measurement points for beam off and beam on conditions to be specified at the floor level, ISOCENTER level and 1 m above the ISOCENTER level (se
24、e requirement 201.10.2.4.2) . 44 Table 201.101 Colours of TREATMENT CONTROL PANEL . 14 Table 201.102 Subclauses in this particular standard requiring the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical description 14 Table 201.103 Subclauses where data
25、is described that is required in the technical description to support Clause 201.10 site test compliance 17 60601-2-11 IEC:2013 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam t
26、herapy equipment 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 stand
27、ardization 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 preparati
28、on 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 with
29、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 subjec
30、ts 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 technical c
31、ontent 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 pos
32、sible 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 itself does not provide any attestation of conformity. Independent certification bodies provide confor
33、mity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its direct
34、ors, 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 of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising
35、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 referenced publications is indispensable for the correct application of this publication. 9) Attention is draw
36、n 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. International Standard IEC 60601-2-11 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclea
37、r medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standa
38、rd in line with the third edition of IEC 60601-1 and its collateral standards. The text of this standard is based on the following documents: FDIS Report on voting 62C/552/FDIS 62C/558/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated
39、 in the above table. 4 60601-2-11 IEC:2013 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of
40、tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one
41、 of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of clause 7). References to clauses within this standa
42、rd are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms u
43、sed in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requir
44、ement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be fou
45、nd on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability 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, withdr
46、awn, replaced by a revised edition, or amended. 60601-2-11 IEC:2013 5 INTRODUCTION The use of GAMMA BEAM THERAPY EQUIPMENT for RADIOTHERAPY purposes may expose PATIENTS to danger if the ME equipment fails to deliver the required dose to the PATIENT, or if the ME equipment design does not satisfy sta
47、ndards of electrical and mechanical safety. The ME EQUIPMENT may also cause danger to persons in the vicinity if the ME equipment itself fails to contain the RADIATION adequately or if there are inadequacies in the design of the TREATMENT ROOM. This particular standard establishes requirements to be
48、 complied with by MANUFACTURERS in the design and construction of gamma beam therapy equipment. Subclause 201.10.2 states tolerance limits beyond which INTERLOCKS must prevent, INTERRUPT or TERMINATE IRRADIATION in order to avoid an unsafe condition. TYPE TESTS which are performed by the MANUFACTURE
49、R, or SITE TESTS, which are not necessarily performed by the MANUFACTURER, are specified for each requirement. Subclause 201.10.2 does not attempt to define the optimum performance requirements for a GAMMA BEAM THERAPY EQUIPMENT for use in RADIOTHERAPY. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such ME EQUIPMENT. It places limits on th
