IEC IEC TR 60601-4-3 Edition 2.0 2018-12 TECHNICAL REPORT colour inside Medical electrical equipment- Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements IEC TR 60601-4-3:2018-12en) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright @ 2018 IEC, Geneva, Switzerland or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's 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 Varembé [email protected] CH-1211 Geneva 20 www.iec.ch Switzerland AbouttheIEC 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. IEc Catalogue-webstore.iec.ch/catalogue Electropedia-www.electropedia.org The stand-alone application for consulting theentire The world's leading online dictionary of electronic and bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in Technical Specifications,Technical Reports.and other English and French, with equivalent terms in 16 additional documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical iPad. Vocabulary (IEV) online. IECpublicationssearch-webstore.iec.ch/advsearchform IEc Glossary-std.iec.ch/glossary The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and varietyofcriteria(referencenumber, text,technical French extracted from the Terms and Definitions clause of iEC publications issued since 2002. Some entries have been committee,...). It also gives information on projects, replaced and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IECJustPublished-webstore.iec.ch/justpublished IEc Customer Service Centre -webstore.iec.ch/csc Stay up to date on all new IEC publications. Just Published details all new publications released.Available online and If you wish to give us your feedback on this publication or also once a month by email. need further assistance, please contact the Customer Service Centre: [email protected]. IEC IEC TR 60601-4-3 Edition 2.02018-12 TECHNICAL REPORT colour inside Medicalelectrical equipment- Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01 ISBN 978-2-8322-6278-8 Warning! Make sure that you obtained this publication from an authorized distributor.