IEC-TR-62296-2003.pdf
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1、TECHNICAL REPORT IEC TR 62296 First edition 2003-03 Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Etudes des aspects de scurit non noncs dans la seconde dition de la CEI 60601-1 et propositions de nouvelles prescriptions Referenc
2、e number IEC/TR 62296:2003(E) Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 23:48:51 MSTNo reproduction or networking permitted without license from IHS -,-,- Publication numbe
3、ring As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer,
4、 respectively, to the base publication, the base publication incorporating amendment 1 and the base publication incorporating amendments 1 and 2. Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content
5、 reflects current technology. Information relating to this publication, including its validity, is available in the IEC Catalogue of publications (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the
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9、: Email: custserviec.ch Tel: +41 22 919 02 11 Fax: +41 22 919 03 00 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 23:48:51 MSTNo reproduction or networking permitted without li
10、cense from IHS -,-,- TECHNICAL REPORT IEC TR 62296 First edition 2003-03 Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Etudes des aspects de scurit non noncs dans la seconde dition de la CEI 60601-1 et propositions de nouvelles p
11、rescriptions PRICE CODE IEC 2003 Copyright - all rights reserved 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 the publisher. International Electrotechnical Com
12、mission, 3, rue de Varemb, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch V For price, see current catalogue Commission Electrotechnique Internationale International Electrotechnical Commission Copyright Internati
13、onal Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 23:48:51 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 TR 62296 IEC:2003(E) CONTENTS FOREWORD 4 INTRODUCTION 5 1Scope a
14、nd object. 6 1.1Scope. 6 1.2Object. 6 2Recommendations . 6 2.1Summary of all recommendations prepared by SC 62A/WG 14 . 6 2.2Recommendation sheets. 9 2.2.1Separation: Reliability of component impedance . 9 2.2.2Separation: Non-complying CREEPAGE DISTANCE and AIR CLEARANCES.10 2.2.3Mains supply trans
15、formers: Overload test 11 2.2.4Mains supply transformers: Short circuit and overload tests.12 2.2.5CREEPAGE DISTANCE and AIR CLEARANCES: Values.13 2.2.6Dielectric strength14 2.2.7Failure of components: Evidence of reliability 15 2.2.8ENCLOSURES and protective covers 16 2.2.9INTERNALLY POWERED EQUIPM
16、ENT: 110 % of the maximum supply voltage17 2.2.10 CREEPAGE DISTANCES and AIR CLEARANCES: Values under 1 mm .18 2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT.19 2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder/switching device20 2.2.13 Fixing, prevention of maladjustment: To
17、rque test .21 2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries22 2.2.15 Excessive temperatures: Ambient temperatures.23 2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS24 2.2.17 ENCLOSURE and protective covers: EQUIPMENT in ambulances 25 2.2.18 Dielectric strength
18、: Voltages appearing from external sources .26 2.2.19 Testing switch mode power supply units (SMPSU).27 2.2.20 Failure of an electrical component: Time periodicity for detection.29 2.2.21 Environmental conditions: Compliance paragraph30 2.2.22 Limitation of voltage and/or energy: Capacitance.31 2.2.
19、23 LEAKAGE CURRENTS: Presence of 45 k resistor in Figure 2132 2.2.24 Humidity preconditioning treatment: Exception from requirement .33 2.2.25 Dielectric strength: EQUIPMENT containing floating circuits34 2.2.26 General requirements for tests: Measurement uncertainty35 2.2.27 CREEPAGE DISTANCES and
20、AIR CLEARANCES: Interpolated values36 2.2.28 Overheating: Change of load resistance.37 2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of external protective earth 38 2.2.30 Rechargeable batteries: No OPERATOR/USER maintenance39 2.2.31 Isolation from the SUPPLY MAINS: Symbol
21、for single pole switch 40 2.2.32 Sequence of testing: Clause 52 before Clause 1941 2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWERED EQUIPMENT.42 2.2.34 Marking on the outside of EQUIPMENT: Type and rating of fuses43 2.2.35 Excessive temperatures: APPLIED PARTS not int
22、ended to supply heat44 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/08/2007 23:48:51 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 62296 IEC:2003(E) 3 2
23、.2.36 Mains supply transformers: Use of PTCs as protective devices45 2.2.37 Components and general assembly: Reliability of components.46 2.2.38 Definition of APPLIED PART: EQUIPMENT worn by PATIENTS47 2.2.39 Construction: Triple insulated winding wire 48 2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES
24、: Dielectric strength test versus CREEPAGE DISTANCES and AIR CLEARANCES.49 2.2.41 Cord anchorages/ Cord guards: In mobile unit with APPLIANCE COUPLER.50 2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or Electronic File Format 51 2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium batteries 5
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