欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    IEC 60601-2-64-2014 Medical electrical equipment - Part 2-64 Particular requirements for the basic safety and essential performance of light ion beam medical el.pdf

    • 资源ID:1241308       资源大小:2MB        全文页数:118页
    • 资源格式: PDF        下载积分:10000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要10000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    IEC 60601-2-64-2014 Medical electrical equipment - Part 2-64 Particular requirements for the basic safety and essential performance of light ion beam medical el.pdf

    1、 IEC 60601-2-64 Edition 1.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment Appareils lectromdicaux Partie 2-64: Exigences particulires po

    2、ur la scurit de base et les performances essentielles des appareils lectromdicaux par faisceau dions lgers IEC 60601-2-64:2014-09(en-fr) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publ

    3、ication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an

    4、 enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous qu

    5、elque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de lIEC ou du Comit national de lIEC du pays du demandeur. Si vous avez des questions sur le copyright de lIEC ou si vous dsirez obtenir des droits supplmentaires sur cet

    6、te publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de lIEC de votre pays de rsidence. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Comm

    7、ission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the l

    8、atest edition, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Availabl

    9、e for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Jus

    10、t Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms

    11、containing more than 30 000 terms and definitions in English and French, with equivalent terms in 14 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary More than 55 000 electrotechnical terminology entries in English and

    12、 French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need

    13、 further assistance, please contact the Customer Service Centre: csciec.ch. A propos de lIEC La Commission Electrotechnique Internationale (IEC) est la premire organisation mondiale qui labore et publie des Normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies

    14、apparentes. A propos des publications IEC Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue IEC - webstore.iec.ch/catalogue Application autonome pour consulter tous

    15、 les renseignements bibliographiques sur les Normes internationales, Spcifications techniques, Rapports techniques et autres documents de lIEC. Disponible pour PC, Mac OS, tablettes Android et iPad. Recherche de publications IEC - www.iec.ch/searchpub La recherche avance permet de trouver des public

    16、ations IEC en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publications remplaces ou retires. IEC Just Published - webstore.iec.ch/justpublished Restez inform sur les nouvelles publications IEC. Just Published dtaille

    17、les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en anglais et en franais, ainsi que les termes quiva

    18、lents dans 14 langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (IEV) en ligne. Glossaire IEC - std.iec.ch/glossary Plus de 55 000 entres terminologiques lectrotechniques, en anglais et en franais, extraites des articles Termes et Dfinitions des publications IEC paru

    19、es depuis 2002. Plus certaines entres antrieures extraites des publications des CE 37, 77, 86 et CISPR de lIEC. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-64 Edition 1.0

    20、2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment Appareils lectromdicaux Partie 2-64: Exigences particulires pour la scurit de base et les

    21、performances essentielles des appareils lectromdicaux par faisceau dions lgers INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XA ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-8322-1825-9 Registered trademark of the International Electrotechnical Commission Marqu

    22、e 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. colour inside 2 IEC 60601-2-64:2014 IEC 2014 CONTENTS FOREWO

    23、RD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references . 8 201.3 Terms and definitions . 9 201.4 General requirements . 14 201.5 General requirements for testing of ME EQUIPMENT 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 15 201.7 ME EQUIPMENT ide

    24、ntification, marking and documents . 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19 201.10 Protection against unwanted and excessive radiation HAZARDS . 24 201.11 Protection against excessive tempe

    25、ratures and other HAZARDS . 45 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 45 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 46 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46 201.15 Construction of ME EQUIPMENT . 46 201.16 M

    26、E SYSTEMS 46 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 46 201.101 ELECTRONIC IMAGING DEVICES (EID) . 47 206 Usability . 47 Annexes . 50 Annex B (informative) Sequence of testing . 50 Annex I (informative) ME SYSTEMS aspects 50 Bibliography 51 Index of defined terms used in

    27、this particular standard 52 Figure 201.101 PATIENT SUPPORT movements . 48 Figure 201.102 Diagram illustrating example RADIATION HEAD components and possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 49 Figure 201.103 Diagram illustrating distance along PATIENT plane to measure NON-PR

    28、IMARY RADIATION ABSORBED DOSE 49 Table 201.101 Data required in the technical description to support Clause 201.10 SITE TEST compliance 17 IEC 60601-2-64:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Particular requirements for the basic safety and essentia

    29、l performance of LIGHT ION BEAM ME 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 al

    30、l questions concerning standardization 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 Publi

    31、cation(s)”). Their preparation 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. IE

    32、C collaborates closely with 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 op

    33、inion on the relevant subjects 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

    34、 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 misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparent

    35、ly to the maximum extent possible 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 certifi

    36、cation bodies provide conformity 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

    37、 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 direct or indirect, or for costs (including legal

    38、 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 indispensable for the correct application of this publi

    39、cation. 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 60601-2-64 has been prepared by subcommittee 62C: Equipm

    40、ent for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. The text of this standard is based on the following documents: FDIS Report on voting 62C/594/FDIS 62C/600/RVD Full information on the voting for the approval of th

    41、is standard can be found in the report on voting indicated in the above table. 4 IEC 60601-2-64:2014 IEC 2014 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 spec

    42、ifications: italic 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 refer

    43、ring to the structure of this standard, the term “clause” means one of the 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 subclaus

    44、es 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

    45、combination 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 th

    46、is 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. A list of all parts of the IEC 60601 series, published under t

    47、he general title Medical electrical equipment, can be found 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.

    48、At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users sh

    49、ould therefore print this document using a colour printer. IEC 60601-2-64:2014 IEC 2014 5 INTRODUCTION The use of LIGHT ION BEAM ME 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 standards of electrical and mechanical safety. The ME EQUIPMENT may also cause danger to per


    注意事项

    本文(IEC 60601-2-64-2014 Medical electrical equipment - Part 2-64 Particular requirements for the basic safety and essential performance of light ion beam medical el.pdf)为本站会员(ownview251)主动上传,麦多课文档分享仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开