The need to stay abreast of state-of-the-art safety principles was a driving force behind the recent revision of a major electrical safety standard, according to Charles Sidebottom, corporate standards director for Medtronic. IEC 60601-1:2005 and its American counterpart, ANSI/AAMI ES60601-1:2005, Medical electrical equipment— Part 1: General requirements for basic safety and essential performance— the standard that has come to be known throughout the industry as the "bible" of medical electrical equipment standards—"has always been about risk management," Sidebottom said during a discussion of the revised medical electrical equipment standard at the recent AAMI/FDA Conference.
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