21 CFR § 880.6860 General Hospital and Personal Use Devices

§ 880.6860 Ethylene oxide gas sterilizer.

Current through Sep 8, 2026 · Read all of Part 880

(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).

← § 880.6855 Rigid sterilization container with electronic monitoring.§ 880.6870 Dry-heat sterilizer. →