View all text of Subpart G [§ 880.6025 - § 880.6992]
§ 880.6860 - Ethylene oxide gas sterilizer.
(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).