21 CFR 880.6860 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — General Hospital And Personal Use Devices (§ 880.1 To § 880.6992) — General Hospital And Personal Use Miscellaneous Devices (§ 880.6025 To § 880.6992) — Ethylene oxide gas sterilizer.
4 Aug 2016
(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).