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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 036 Date of Entry 07/09/2014 
FR Recognition Number 14-432
Standard
ANSI AAMI  ST58:2013/(R)2018
Chemical sterilization and high-level disinfection in health care facilities
Scope/Abstract
This standard provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other healthcare facilities. Included within the scope of this standard are functional and physical design criteria; staff qualifications and education; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use; quality control methods; and quality process improvement.
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.

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
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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