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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 14-213: AOAC 6.2.03:2006, official method 991.48, testing disinfectants against staphylococcus aureus, hard surface carrier test method. (Sterility)

Date of Standard: 2006. 
Address of Standards Development Organization:
 AOAC International (AOAC)
  481 North Frederick Avenue
  Suite 500
  Gaithersburg, MD 20877-2417
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Liquid chemical sterilants (high level disinfectants), general purpose disinfectants
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:
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

ANSI/AAMI ST58:2005/(R)2010, Chemical sterilization and high-level disinfection in health care facilities
FDA Technical Contacts:
 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
 Sharon Lappalainen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3628
  Silver Spring MD 20993
  301/796-6322
  email: sharon.lappalainen@fda.hhs.gov
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