IEC_TR_60601-4-2-2016.pdf

IEC TR 60601-4-2 Edition 1.0 2016-05 TECHNICAL REPORT Medical electrical equipment Part 4-2:Guidance and interpretation Electromagnetic immunity:performance of medical electrical equipment and medical electrical sy stems IEC TR 60601-4-2:2016-05(en)colourinside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2016 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 A bout 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.IEC Catalogue-webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical infor mation on IEC Inter national Standards,Technical Specifications,Technical Reports and other documents.Available for PC,Mac OS,Andr oid Tablets and iPad.IEC publications search-www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criter ia(r efer ence number,text,technical committee,).It also gives information on pr ojects,replaced and w ithdr awn 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 online and also once a month by email.Electropedia-www.electropedia.org The w or lds leading online dictionary of electronic and electr ical terms containing 20 000 ter ms and definitions in English and French,w ith equivalent terms in 15 additional languages.Also k now n as the Inter national Electr otechnical Vocabulary (IEV)online.IEC Glossary -std.iec.ch/glossary 65 000 electrotechnical ter minology entr ies in English and French extr acted from the Terms and Definitions clause of IEC publications issued since 2002.Some entr ies have been collected fr om earlier publications of IEC TC 37,77,86 and CISPR.IEC Customer Serv ice Centre-webstore.iec.ch/csc If you w ish to give us y our feedback on this publication or need further assistance,please contact the Customer Ser vice Centr e:csciec.ch.IEC TR 60601-4-2 Edition 1.0 2016-05 TECHNICAL REPORT Medical electrical equipment Part 4-2:Guidance and interpretation Electromagnetic immunity:performance of medical electrical equipment and medical electrical sy stems INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01;33.100.20 ISBN 978-2-8322-3414-3 Registered trademark of the International Electrotechnical Commission Warning!Make sure that y ou obtained this publication from an authorized distributor.colourinside 2 IEC TR 60601-4-2:2016 IEC 2016 CONTENTS FOREWORD.5 INTRODUCTION.8 0.1*General.8 0.2 Purpose of this document.8 0.3 How to use this document.8 0.4 IMMUNITY TEST LEVELS.9 1 Scope and object.10 1.1 Scope.10 1.2 Object.10 2 Normative references.10 3 Terms and definitions.11 4 General recommendations.15 4.1 Concurrent and sequential testing.15 4.2 General test conditions.15 4.2.1 Configurations.15 4.2.2 Artificial hand.15 4.2.3 Power input voltages and frequencies.16 5 ME EQUIPMENT and ME SYSTEMS identification,marking and documents.17 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the connector testing exemption specified in 8.13.2 c)is used.17 5.2 ACCOMPANYING DOCUMENTS.17 5.2.1 General.17 5.2.2 Instructions for use.17 5.2.3 Requirements applicable to ME EQUIPMENT and ME SYSTEMS for which the connector testing exemption specified in 8.13.2 c)is used.17 5.2.4*Technical description.17 6 Documentation of the tests.18 6.1 Test plan.18 6.2 Test report.19 7*EMISSIONS.19 8 IMMUNITY recommendations.19 8.1 General.19 8.2 PATIENT physiological simulation.20 8.3 Termination of PATIENT-COUPLED parts.21 8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD.21 8.5 Subsystems.21 8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS.21 8.7 Operating modes.22 8.8 Non-ME EQUIPMENT.22 8.9*Environments of INTENDED USE.22 8.10*Performance criteria.23 8.11*IMMUNITY TEST LEVELS.23 8.12*IMMUNITY to proximity fields from RF wireless communications equipment.30 8.13*ESD testing of connectors.31 8.13.1 Application of ESD to connectors.31 8.13.2 Exclusions.32 IEC TR 60601-4-2:2016 IEC