1、 IEC/TR 62348 Edition 2.0 2012-12 TECHNICAL REPORT Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition IEC/TR 62348:2012(E)colourinsideCopyrighted material licensed to BR Demo by Thomson Re
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10、Uncontrolled when printed.IEC/TR 62348 Edition 2.0 2012-12 TECHNICAL REPORT Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition INTERNATIONAL ELECTROTECHNICAL COMMISSION XD ICS 11.040 PRICE
11、 CODE ISBN 978-2-83220-548-8 Registered trademark of the International Electrotechnical Commission Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideCopyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,downloaded on Nov-27-2014 by
12、 James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.2 TR 62348 IEC:2012(E)CONTENTS FOREWORD.6 INTRODUCTION.8 1 Scope.9 2 Normative references.9 3 Terms and definitions.9 4 Assessment of the changes in Amendment 1:2012.9 5 Changes impacting many users of the
13、standard.13 5.1 Updated normative references(Clause 2)Moderate impact.13 5.2 Definition and rationale for EXPECTED SERVICE LIFE(Definition 3.28 and rationale for 4.4)Moderate impact.13 5.3 Restructuring of RISK MANAGEMENT(Subclause 4.2)Significant impact.13 5.4 Application of ESSENTIAL PERFORMANCE(S
14、ubclause 4.3)Significant impact.13 5.5 Revision to the concept of equivalent safety(Subclause 4.5)Significant impact.14 5.6 Requirements for parts that contact the PATIENT(Subclause 4.6)Significant impact.14 5.7 Steady-state measurement of input of the ME EQUIPMENT or ME SYSTEM(Subclause 4.11)Modera
15、te impact.14 5.8 Simultaneous fault testing(Subclause 5.1)Moderate impact.14 5.9 SUPPLY MAINS test characteristics(Subclause 5.5 a)Significant impact.15 5.10 Humidity preconditioning(Subclause 5.7)Significant impact.15 5.11 Actuating mechanisms(Subclause 5.9.2.3)Moderate impact.15 5.12 Legibility of
16、 markings(Subclause 7.1.2)Moderate impact.15 5.13 Identification of ME EQUIPMENT,parts and ACCESSORIES(Subclauses 7.2.1 and 7.2.4)Significant impact.15 5.14 Marking of fuses,THERMAL CUT-OUTS and OVER-CURRENT RELEASES(Subclause 7.3.4)Moderate impact.15 5.15 Marking of stand-by control(Subclause 7.4.2)Moderate impact.15 5.16 Use of safety signs(Subclause 7.5)Moderate impact.16 5.17 General requirements for ACCOMPANYING DOCUMENTS(Subclause 7.9.1)Significant impact.16 5.18 Disposal of waste(Subcl
