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ANSI/AAMI ES60601-1:2005, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance is the third edition of the standard that covers any medical device that requires an electrical outlet or a battery. It has come to be known throughout the industry as the “bible” of medical electrical equipment standards. The standard covers many safety and fundamental application topics such as signage, leakage current, creepage, alarms, risk management plans, methods of sterilization as described below and more.

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