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IEC/TR 62348

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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Organization: IEC
Publication Date: 1 December 2012
Status: active
Page Count: 106
ICS Code (Medical equipment): 11.040
scope:

This 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;

- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.

Document History

IEC/TR 62348
December 1, 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
This 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...
May 1, 2006
Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended
This technical report 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;...

References

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