21 CFR § 880.6885 - Liquid chemical sterilants/high level disinfectants.

---
identifier: "/us/cfr/t21/s880.6885"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6885 - Liquid chemical sterilants/high level disinfectants."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6885"
section_name: "Liquid chemical sterilants/high level disinfectants."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.6885 Liquid chemical sterilants/high level disinfectants.

(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.

[65 FR 36325, June 8, 2000]