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.)
