21 CFR 880.6860

§ 880.6860 Ethylene oxide gas sterilizer.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 880.6860, § 880.6860 Ethylene oxide gas sterilizer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90605
Permanent ID: ys:prov:90605@1
SHA-256: f75497f5ed8763184cf48705361d345616bfb9d257e751c863506311250cbf14

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Full text

(a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products. (b) Classification. Class II (performance standards).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.