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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 14-294: AAMI / ANSI ST40:2004/(R)2010, table-top dry heat (heated air) sterilization and sterility assurance in dental and medical facilities, 2ed.. (Sterility)

Date of Standard: 2004/(R)2010. 
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 Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
All devices that can be sterilized by dry heat in medical or dental facilities
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.6870 Sterilizer, Dry Heat Class 2 KMH
Relevant Guidance:
Supplement to ANSI/AAMI ST50:2004, Dry Heat (Heated Air) Sterilizers
FDA Technical Contact:
 Elaine Mayhall, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2612
  Silver Spring MD 20993
  301/796-6301
  email: elaine.mayhall@fda.hhs.gov
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