Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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14-607
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Standard | |
ANSI AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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.
Note: Legally marketed cleaning verification tests for use with medical devices and with mechanical cleaning equipment in health care facilities are not currently available. We encourage you to contact the review division regarding cleaning verification tests for your device. |
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Transition Period
FDA recognition of ANSI AAMI ST58:2013/(R)2018 [Rec# 14-432] will be superseded by recognition of ANSI AAMI ST58:2024 [Rec# 14-607]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-432] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 14-432] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.6885 |
Sterilant, Medical Devices
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Class 2
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MED
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§880.6890 |
Disinfectant, Medical Devices
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Class 1
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LRJ
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Relevant FDA Guidance and/or Supportive Publications*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and FDA staff, issued June 2017.
Medical Washers and Medical Washer-Disinfectors - Class II Special Controls - Guidance for Industry and FDA review staff, issued February 2002.
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. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |