21 CFR 880.6885
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.6885, § 880.6885 Liquid chemical sterilants/high level disinfectants, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90608
- Permanent ID
ys:prov:90608@1- SHA-256
48c4201bfaf1ab5e1f2ed026cad53fa95ba6a75b3e04062957a2dd2d333456df
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Full text
(a) Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
(b) Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.