21 C.F.R. § 880.6860 Ethylene oxide gas sterilizer.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices
§ 880.6860 Ethylene oxide gas sterilizer.
