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AAMI TIR62348
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AAMI TIR62348 2012 Edition, January 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
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Description / Abstract:
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.
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.