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    IEC 80601-2-35-2009 Medical electrical equipment - Part 2-35 Particular requirements for the basic safety and essential performance of heating devices using blankets pads or mattre.pdf

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    IEC 80601-2-35-2009 Medical electrical equipment - Part 2-35 Particular requirements for the basic safety and essential performance of heating devices using blankets pads or mattre.pdf

    1、 IEC 80601-2-35Edition 2.0 2009-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use Appareils lectromd

    2、icaux Partie 2-35: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destins au rchauffage des patients en usage mdical IEC80601-2-35:2009 colourinsideTHIS PUBLICATION IS C

    3、OPYRIGHT PROTECTED Copyright 2009 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 microfilm, without permission in writing from either

    4、 IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits

    5、 de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI d

    6、u pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva

    7、 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical c

    8、ontent of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria

    9、 (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available o

    10、n-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnica

    11、l Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI

    12、 La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI es

    13、t constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents cr

    14、itres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles

    15、 publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues

    16、additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous

    17、: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 80601-2-35Edition 2.0 2009-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattres

    18、ses and intended for heating in medical use Appareils lectromdicaux Partie 2-35: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destins au rchauffage des patients en usa

    19、ge mdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 11.140 PRICE CODECODE PRIXISBN 2-8318-1065-7colourinside 2 80601-2-35 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references10 201.3 Terms

    20、 and definitions10 201.4 General requirements .13 201.5 General requirements for testing ME EQUIPMENT 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS14 201.7 ME EQUIPMENT identification, marking and documents .14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .17 201.9 Protecti

    21、on against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .22 201.10 Protection against unwanted and excessive radiation HAZARDS .24 201.11 Protection against excessive temperatures and other HAZARDS .24 201.12 Accuracy of controls and instruments and protection against hazardous outputs .27 201.

    22、13 HAZARDOUS SITUATIONS and fault conditions 32 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 37 201.15 Construction of ME EQUIPMENT.37 201.16 ME SYSTEMS 41 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .41 202 Electromagnetic compatibility Requirements and tests .42 20

    23、8 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.42 210 * Requirements for the development of physiologic closed-loop controllers .42 Annex D (informative) Symbols on marking43 Annex AA (informative) Particular guidance and r

    24、ationale44 Annex BB (normative) Determination of the LAGGING MATERIAL .55 Annex CC (normative) *Determination of heat transfer towards the PATIENT .56 Annex DD (normative) *Determination of heat transfer away from the PATIENT .58 Annex EE (normative) Conditions of adequate heat discharge .59 Annex F

    25、F (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES60 Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES under SINGLE FAULT CONDITION.62 Annex HH (normative) Safety test procedure for average CONTACT SURFACE TEMP

    26、ERATURE for FORCED AIR DEVICES63 Bibliography65 Index of defined terms used in this particular standard66 Figure 201.101 Positioning of temperature sensors on the contact surface of the heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105).11 Figure 201.102 Example of the positioning o

    27、f temperature sensors on the contact surface of the heated areas of a HEATING DEVICE having more than one separately heated area 11 80601-2-35 IEC:2009 3 Figure 201.103 a) Apparatus for the spark ignition test Detail A: The apparatus (see 201.8.8.4.101).19 Figure 201.103 b) Apparatus for the spark i

    28、gnition test Detail B: Lower member of mask.20 Figure 201.103 c) Apparatus for the spark ignition test Detail C: Upper member of mask.20 Figure 201.103 Apparatus for the spark ignition test 20 Figure 201.104 Ramp for the impact test on PADS 23 Figure 201.105 Partial covering conditions.25 Figure 201

    29、.106 Method of folding BLANKETS .34 Figure 201.107 Examples of folds 36 Figure 201.108 Positions of a BLANKET for the RUCK-RESISTANCE test41 Figure HH.1 Sensor locations Average CONTACT SURFACE TEMPERATURE64 Table 201.101 *Additional ESSENTIAL PERFORMANCE requirements 13 Table 201.102 Temperature li

    30、mits in dependency to time.38 4 80601-2-35 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

    31、 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 standardization in th

    32、e 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 preparation is entrusted

    33、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 the Internationa

    34、l 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 subjects since each te

    35、chnical 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 content of IEC Pu

    36、blications 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 possible in their n

    37、ational 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 conformity assessment

    38、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 directors, employees,

    39、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 out of the publi

    40、cation, 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 drawn to the possibi

    41、lity 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 80601-2-35 has been prepared by IEC technical committee 62D: Electromedical equipment, of IEC techni

    42、cal committee 62: Electrical equipment in medical practice, and subcommittee 1: Breathing attachments and anaesthetic machines, of ISO technical committee 121: Anaesthetic and respiratory equipment. This second edition cancels and replaces the first edition published in 1996. This edition constitute

    43、s a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible. 80601-2-35 IEC:2009 5 The text of this particular standard is based on the

    44、following documents: FDIS Report on voting 62D/784A/FDIS 62D/804/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 15 P-members out of 15 having cast a vote. Thi

    45、s 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 tables, such as notes, examples and references

    46、: 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 of the seventeen numbered divisions within th

    47、e 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 standard are preceded by the term “Clause” followed

    48、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 combination of the conditions is true. The verbal forms used in this standard conform to usage describe

    49、d 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 requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to ach


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