PDF Standards AAMI ES60601-1:2005

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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.)

Product Details

Published:

02/09/2006

ISBN(s):

157020246X

ANSI:

ANSI Approved

Number of Pages:

321

File Size:

1 file , 2.7 MB