AAMI ES60601-1:2005


Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006

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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

  • Includes a risk management model – based on ANSI/AAMI/ISO 14971
  • Introduces the concept of essential performance – a measure of a device’s effect on user and patient safety
  • Offers flexibility in meeting requirements, for example, different requirement levels for parts that come into contact with the user vs. parts that come in contact with the patient.
  • Provides structured method for manufacturers to demonstrate equivalent safety of alternate means of compliance
  • Identical to IEC 60601-1 but with U.S. deviations to comply with U.S. National Electric Code. (IEC text is also included for reference.)

Product Details

ANSI Approved
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