Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/15/2013 
FR Recognition Number 14-217
Standard
AOAC  6.3.02:2006
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
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
 Yong Xue
  CDRH/OPEQ/OHTIV/DHTIVC
  --
  Yong.Xue@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.
-
-