IEC_60601-2-13-2009.pdf

IEC 60601-2-13Edition 3.1 2009-08INTERNATIONAL STANDARD Medical electrical equipment Part 2-13:Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003+A1:2006(E)LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.THIS PUBLICATION IS COPYRIGHT 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 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.IEC Central Office 3,rue de Varemb CH-1211 Geneva 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 content 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to search by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,withdrawn and replaced publications.?IEC Just Published:www.iec.ch/online_news/justpub Stay up to date on all new IEC publications.Just Published details twice a month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 on-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 Electrotechnical 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 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC 60601-2-13Edition 3.1 2009-08INTERNATIONAL STANDARD Medical electrical equipment Part 2-13:Particular requirements for the safety and essential performance of anaesthetic systems INTERNATIONAL ELECTROTECHNICAL COMMISSION CJICS 11.040.10 PRICE CODEISBN 2-8318-1058-8 Registered trademark of the International Electrotechnical Commission LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 60601-2-13 IEC:2003+A1:2006(E)CONTENTS FOREWORD.4 INTRODUCTION.6 SECTION ONE GENERAL 1 Scope and object.7 2 Terminology and definitions.10 3 General requirements.12 4 General requirements for tests.12 6 Identification,marking and documents.12 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environmental conditions.17 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS*43 Fire prevention.18 44 Overflow,spillage,leakage,humidity,ingress of liquids,cleaning,sterilization and disinfection.19 49 Interruption of the POWER SUPPLY.19 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 51 Protection against hazardous output.20 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions.24 SECTION TEN CONSTRUCTIONAL REQUIREMENTS 54 General.24 56 Components and general assembly.24 57 MAINS PARTS,components and layout.25 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.60601-2-13 IEC:2003+A1:2006(E)3 SECTION 101 ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS DELIVERY SYSTEMS 101 Medical gas supply.26 102 Medical gas pipeline inlet connections.26 103 Medical gas supply pressure monitoring.26 104 Medical gas supply PRESSURE REGULATORs.27 105 Anaesthetic gas delivery system piping.27 106 Gas flow metering.27 107 Gas mixer.29 108 Oxygen flush.29 109 Fresh gas outlet.30 110 Checklist.30 Annex AA (informative)Guidance and rationale for particular clauses and subclauses in this particular standard.31 Annex BB(informative)MONITORING DEVICES,ALARM SYSTEM(S)and PROTECTION DEVICES.35 Annex CC(informative)Separate devices of an ANAESTHETIC SYSTEM.36