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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 14-290: AAMI / ANSI ST24:1999/(R) 2009, automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.. (Sterility)

Date of Standard: 1999/(R)2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
CDRH Offices and Divisions associated with recognized standards:
Devices Affected:
Ethylene oxide sterilizers used in health care facilities
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Device Name Device
§880.6860 Sterilizer, Ethylene-Oxide Gas Class 2 FLF
Relevant Guidance:
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, March, 1993

Addendum to Sterilizer Guidance Document, September 19, 1995
FDA Technical Contact:
 Steven Turtil
  10903 New Hampshire Avenue Building 66, Room 1570
  Silver Spring MD 20993
  email: steven.turtil@fda.hhs.gov