1、 IEC/TR 62296Edition 2.0 2009-01TECHNICAL REPORT Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements IEC/TR 62296:2009(E)LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.T
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10、ciec.ch Tel.:+41 22 919 02 11 Fax:+41 22 919 03 00 LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC/TR 62296Edition 2.0 2009-01TECHNICAL REPORT Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and pr
11、oposals for new requirements INTERNATIONAL ELECTROTECHNICAL COMMISSION XCICS 11.040 PRICE CODEISBN 2-8318-1025-1 Registered trademark of the International Electrotechnical Commission LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 TR
12、 62296 IEC:2009(E)CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope and object.7 1.1 Scope.7 1.2 Object.7 2 Recommendations.7 2.1 Summary of all recommendations prepared by SC 62A/WG 14.7 2.2 Recommendation sheets.10 2.2.1 Separation:Reliability of component impedance.10 2.2.2 Separation:Non-complying cree
13、page distance and air clearances.12 2.2.3 Mains supply transformers:Overload test.13 2.2.4 Mains supply transformers:Short circuit and overload tests.14 2.2.5 Creepage distance and air clearances:Values.15 2.2.6 Dielectric strength.16 2.2.7 Failure of components:Evidence of reliability.17 2.2.8 ENCL
14、OSURES and protective covers.18 2.2.9 INTERNALLY POWERED EQUIPMENT:110%of the maximum supply voltage.19 2.2.10 Creepage distances and air clearances:Values under 1 mm.20 2.2.11 Separation:Secondary circuit impedance limit LEAKAGE CURRENT.21 2.2.12 ENCLOSURES and PROTECTIVE COVERS:Lampholder/switchin
15、g device.22 2.2.13 Fixing,prevention of maladjustment:Torque test.23 2.2.14 Batteries not intended to be changed by OPERATOR:Lithium batteries.24 2.2.15 Excessive temperatures:Ambient temperatures.25 2.2.16 Continuous LEAKAGE CURRENTS:Different SUPPLY MAINS.26 2.2.17 ENCLOSURE and protective covers:
16、EQUIPMENT in ambulances.27 2.2.18 Dielectric strength:Voltages appearing from external sources.28 2.2.19 Testing switch mode power supply units(SMPSU).29 2.2.20 Failure of an electrical component:Time periodicity for detection.30 2.2.21 Environmental conditions:Compliance paragraph.31 2.2.22 Limitation of voltage and/or energy:Capacitance.32 2.2.23 LEAKAGE CURRENTS:Presence of 45 k resistor in Figure 21.33 2.2.24 Humidity preconditioning treatment:Exception from requirement.34 2.2.25 Dielectric