Title 21

SECTION 880.6860

880.6860 Ethylene oxide gas sterilizer.

§ 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).