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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 14-413
Standard
AOAC 6.2.06:2013
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.6890 Disinfectant, Medical Devices Class 1 LRJ
§880.6885 Sterilant, Medical Devices Class 2 MED
Relevant FDA Guidance and/or Supportive Publications
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers, Issued January 2000.

ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.
FDA Technical Contacts
 Myra Smith
  FDA/OMPT/CDRH/ODE/DNPMD/NIDB/
  301-796-6507
  Myra.Smith@fda.hhs.gov
 Elaine Mayhall
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
Standards Development Organization
AOAC AOAC International https://www.aoac.org/
FDA Specialty Task Group (STG)
Sterility
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