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:||1 December 2012|
|ICS Code (Medical equipment):||11.040|
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.