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) which is a technical report, provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by:
- those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended;
- manufacturers of medical electrical equipment or medical electrical systems; and
- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems. This second edition cancels and replaces the first edition published in 2006. The second edition retains the mapping that traces the requirements of IEC 60601-1:2005 and its Amendment A1:2012 (Edition 3.1) from their source in the documents that relate to IEC 60601-1:1998 and its amendments (Edition 2.2). The second edition adds an assessment of the impact of the most significant changes in Amendment 1:2012.

General Information

Status
Published
Publication Date
11-Dec-2012
Current Stage
PPUB - Publication issued
Start Date
15-Mar-2013
Completion Date
12-Dec-2012
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IEC TR 62348:2012 - 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
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IEC/TR 62348
®

Edition 2.0 2012-12
TECHNICAL
REPORT

colour
inside


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)

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IEC/TR 62348

®


Edition 2.0 2012-12




TECHNICAL



REPORT








colour

inside










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


























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ICS 11.040 ISBN 978-2-83220-548-8



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– 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 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 (Subclause 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] .
...

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