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Reference IEC/TR 62348 ed2.0 withdrawn corrigendum
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Title 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
Publication date 2012-12-12
Format, price
(Swiss francs)
and language
300.- 101 pages
300.- 1551 Kb
Abstract 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.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040 Medical equipment
Replaced by
Stability date 2019
Work in progress
ProjectStage codeForecast publication date
No project under development--


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