Standard

AAMI ES60601-1:2005

Feb 2006 Withdrawn

Note: This standard has a new edition: AAMI ES60601-1: 2005 & A1:2012 & A2:2021

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Abstract

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.)

Document information

Standard from AAMI
Published: 9 February 2006
Version: 0
Document type: IS
Pages
ISBN:

Product Relations

Replaced by: AAMI ES60601-1:2005 and ES60601-1:2005/C1:2009

AAMI ES60601-1:2005

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