60601-1, The Third Edition
Major Update to Medical Electrical Equipment Standard
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.
Click here to view the Table of Contents (pdf)
- 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.)
