scope:

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; 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; - 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.