1260765 Preview

AAMI ES60601-1:2005

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

This document has been replaced. View the most recent version.

View all product details

Historical

Track It

Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $435.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

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 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
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI ES60601-1: 2005 & A1:2012 & A2:2021


    Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION

    • Most Recent

  2. AAMI ES60601-1:2005/(R)2012 (Consolidated Text)


    Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), Consolidated Text of ES60601-1:2005/(R)2012 and A1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012

    • Historical Version

  3. AAMI ES60601-1:2005/(R)2012


    Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Consolidated Text

    • Historical Version

  4. AAMI ES60601-1:2005 and ES60601-1:2005/C1:2009


    Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

    • Historical Version

  5. AAMI ES60601-1:2005

    👀 currently
    viewing


    Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

    • Historical Version

  6. AAMI ES1-1993


    Safe Current Limits for Electromedical Apparatus

    • Historical Version