21 C.F.R. § 880.6100 Ethylene oxide gas aerator cabinet.
Title 21 - Food and Drugs
(a) Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air. (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
§ 880.6100 Ethylene oxide gas aerator cabinet.
