IEC 60601-2-29-2008 Medical electrical equipment - Part 2-29 Particular requirements for the basic safety and essential performance of radiotherapy simulators《医.pdf

1、 IEC 60601-2-29 Edition 3.0 2008-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators Appareils lectromdicaux Partie 2-29: Exigences particulires pour la scurit de base

2、 et les performances essentielles des simulateurs de radiothrapie IEC 60601-2-29:2008 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

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16、es sur cette publication 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 60601-2-29 Edition 3.0 2008-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-29: Particular

17、requirements for the basic safety and essential performance of radiotherapy simulators Appareils lectromdicaux Partie 2-29: Exigences particulires pour la scurit de base et les performances essentielles des simulateurs de radiothrapie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHN

18、IQUE INTERNATIONALE T ICS 11.040.60 PRICE CODE CODE PRIX ISBN 2-8318-9854-4 2 60601-2-29 IEC:2008 CONTENTS FOREWORD.3 INTRODUCTION.5 201.1 Scope, object and related standards .6 201.2 Normative references7 201.3 Terms and definitions8 201.4 General requirements8 201.5 General requirements for testin

19、g of ME EQUIPMENT.8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS8 201.7 ME EQUIPMENT identification, marking and documents9 201.8 Protection against electrical HAZARDS from ME EQUIPMENT11 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS11 201.10 Protection against un

20、wanted and excessive radiation HAZARDS18 201.11 Protection against excessive temperatures and other HAZARDS18 201.12 Accuracy of controls and instruments and protection against hazardous outputs19 201.13 HAZARDOUS SITUATIONS and fault conditions.19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEM

21、S) .19 201.15 Construction of ME EQUIPMENT .19 201.16 ME SYSTEMS 19 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .19 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS20 Annex AA (informative) Particular guidance and rationale21 B

22、ibliography22 Index of defined terms used in this particular standard23 Figure 101 Equipment movements and scales Rotary GANTRY with identification of axes 1 to 8, directions 9 to 13, and dimensions 14 and 15 (see accompanying table) .14 Figure 102 Equipment movements and scales ISOCENTRIC RADIOTHER

23、APY SIMULATOR or TELERADIOTHERAPY ME EQUIPMENT, with identification of axes 1; 4 to 6; 19, of directions 9 to 12; 16 to 18 and of dimensions 14; 15 (see accompanying table)15 Figure 103 Equipment movements and scales View from RADIATION SOURCE of TELERADIOTHERAPY RADIATION FIELD or RADIOTHERAPY SIMU

24、LATOR DELINEATED RADIATION FIELD (see accompanying table) 16 Table 201.101 Description of equipment movements .17 Table 201.C.101 ACCOMPANYING DOCUMENTS, General .20 Table 201.C.102 ACCOMPANYING DOCUMENTS, Instructions for use20 Table 201.C.103 ACCOMPANYING DOCUMENTS, technical description20 60601-2

25、-29 IEC:2008 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standar

26、dization 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 other activities, IEC publishes Inter

27、national Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate

28、 in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between

29、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 subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications h

30、ave 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 content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any mi

31、sinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding nat

32、ional 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 ensure that they have the latest editio

33、n 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 of any nature whatsoever, whether direc

34、t 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 referenced publications is indispensab

35、le 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. International standard IEC 60601-2-29 h

36、as been prepared by IEC subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical

37、revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. The text of this particular standard is based on the following documents: CDV Report on voting 62C/423/CDV 62C/434/RVC Full information on the voting for the approval of this particular s

38、tandard can be found in the report on voting indicated in the above table. 4 60601-2-29 IEC:2008 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: i

39、talic type. Informative material appearing outside of 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 s

40、tructure of this standard, the term “clause” means one 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

41、of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any com

42、bination of the conditions is true. The verbal forms used 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

43、standard; “should” means that compliance with a requirement 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. An asterisk (*) as the first character of a title or at the begin

44、ning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A. A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents

45、 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 publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 60601-2-2

46、9 IEC:2008 5 INTRODUCTION This particular standard establishes requirements to be complied with by MANUFACTURERS in the design and construction of RADIOTHERAPY SIMULATORS; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that a

47、re regarded, at the present time, as essential for the safe operation of such ME EQUIPMENT. It places limits on the degradation of ME EQUIPMENT performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an INTERLOCK then operates to prevent

48、continued operation of the ME EQUIPMENT. 6 60601-2-29 IEC:2008 MEDICAL ELECTRICAL EQUIPMENT Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators 201.1 Scope, object and related standards Clause 1 of the general standard 1)applies, except as fol

49、lows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of RADIOTHERAPY SIMULATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or s