Full 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 standardsIncludes a risk management model - based on ANSI/AAMI/ISO 14971Introduces the concept of essential performance - a measure of a device's effect on user and patient safetyOffers 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 complianceIdentical 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

Published: 02/09/2006 ISBN(s): 157020246X ANSI: ANSI Approved Number of Pages: 321File Size: 1 file , 2.7 MB