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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 14-432: AAMI / ANSI ST58:2013, chemical sterilization and high-level disinfection in health care facilities. (Sterility)

Date of Standard: 2013. 
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:
Medical devices that are reprocessed using glutaraldehyde-based products
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
§880.6885 Sterilant, Medical Devices Class 2 MED
§880.6890 Disinfectant, Medical Devices Class 1 LRJ
Relevant Guidance:
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, January 3, 2000
FDA Technical Contacts:
 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
 Geetha C. Jayan, M.V.Sc, Ph.D
  FDA/CDRH/OCD
  10903 New Hampshire Avenue Building 66, Room 3622
  Silver Spring MD 20993
  301/796-6300
  email: geetha.jayan@fda.hhs.gov
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