| ANSI AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 14-432 |
| Extent | Complete standard |
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| STG | Sterility |
| FDA Tech | Elaine Mayhall FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-6301 Elaine.Mayhall@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6890 | Disinfectant, Medical Devices | Class 1 | LRJ |
| §880.6885 | Sterilant, Medical Devices | Class 2 | MED |
| 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. |