Ethylene oxide gas sterilizer.
21 C.F.R. § 880.6860
in effectEffective: 2024-07-01(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).
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
