AAMI ES60601-1:2005

$237.00

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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Category: AAMI

Description

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.)