IEC_60601-1-2012.pdf

IEC 60601-1 Edition 3.1 2012-08 INTERNATIONAL STANDARD Medical electrical equipment Part 1:General requirements for basic safety and essential performance IEC 60601-1:2005+A1:2012(E)colourinside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 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 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 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.Useful links:IEC publications search-www.iec.ch/searchpub The advanced search enables you 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by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,replaced and withdrawn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications released.Available on-line and also once a month by email.Electropedia-www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French,with equivalent terms in additional languages.Also known as the International Electrotechnical Vocabulary(IEV)on-line.Customer Service Centre-webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance,please contact the Customer Service Centre:csciec.ch.IEC 60601-1 Edition 3.1 2012-08 INTERNATIONAL STANDARD Medical electrical equipment Part 1:General requirements for basic safety and essential performance INTERNATIONAL ELECTROTECHNICAL COMMISSION CW ICS 11.040 PRICE CODE ISBN 978-2-8322-0331-6 Registered trademark of the International Electrotechnical Commission Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideApril 2008 Publication IEC 60601-1(Third edition 2005)I-SH 01 MEDICAL ELECTRICAL EQUIPMENT Part 1:General requirements for basic safety and essential performance INTERPRETATION SHEET 1 This interpretation sheet has been prepared by SC 62A:Common aspects of electrical equipment used in medical practice The text of this interpretation sheet is based on the following documents:ISH Report on voting 62A/599/ISH 62A/613/RVD Full information on the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table._ Subclause 1.1 This subclause is clarified by the following:IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1,Medical gas pipeline systems Part 1:Pipeline systems for compressed medical gases and vacuum.NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm signals.This clarification will remain valid until a new version of IEC 60601-1 is published._ 1 January 2009 ICS 11.040 French text overleaf Publication IEC 60601-1(Third edition 2005)I-SH 02 MEDICAL ELECTRICAL EQUIPMENT Part 1:General requirements for basic safety and essential performance INTERPRETATION SHEET 2 This interpretation sheet has been prepared by subcomittee 62A:Common aspects of electrical equipment used in medical practice,of IEC technical committee 62:Electrical equipment in medical practice.The text of this interpretation sheet is based on the following documents:ISH Report on voting 62A/634/ISH 62A/640/RVD Full information on the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table._ Subclause 11.3 This subclause is clarified by the following:As stated in the rationale for this subclause,fire ENCLOSURES are intended to be used only where there is a significant likelihood of fire due to the presence of a source of ignition(as described in the subclause)and a significant source of fuel.Most materials used in the construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are in the presence of an OXYGEN RICH ENVIRONMENT.MANUFACTURERS should determine,through analyses documented in the RISK MANAGEMENT FILE,whether the ME EQUIPMENT contains combustible materials(fuel)in suffi