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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 14-412
Standard
AOAC  6.2.01:2013
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
Scope/Abstract
(Applicable to testing disinfectants miscible with H2O to determine effectiveness of given bactericidal concentration using standard test strains under controlled conditions. Test results may not necessarily reflect a product's efficacy on a variety of inanimate surfaces or within specified environments. These microbiological methods are very sensitive and technique-oriented. Exact adherence to the method with identified critical control points, good microbiological techniques, good laboratory practices, and quality control are required for proficiency and for validity of results. It is essential that the glass carriers employed in these tests are discarded after one use. Do not reuse carriers.)

Caution: Potential biohazard. Bacteria used in this method, Salmonella choleraesuis, Staphylococcus aureus, and Pseudmonas aeruginosa, are potentially pathogenic microorganisms. Follow Biosafety Level 2 practices and techniques when handling these microorganisms. For more information see "CDC/NIH Biosafety in Microbiological and Biomedical Laboratories" 2nd Ed., May 1988, U.S. Department of Health and Human Services. Available from the U.S. Government Printing Office, Washington, DC, USA (Stock No. 107-040-000508-3).
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
§880.6885 Sterilant, Medical Devices Class 2 MED
§880.6890 Disinfectant, Medical Devices Class 1 LRJ
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Lianji Jin
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVC/
  240-402-4779
  Lianji.Jin@fda.hhs.gov
Standards Development Organization
AOAC AOAC International https://www.aoac.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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