1、 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 PROTECT
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11、erpretation 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
12、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 Normativ
13、e 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 docu
14、ments.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
15、 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 part
16、s.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
