21 CFR 880.6100
§ 880.6100 Ethylene oxide gas aerator cabinet.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.6100, § 880.6100 Ethylene oxide gas aerator cabinet, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90571
- Permanent ID
ys:prov:90571@1- SHA-256
0e57436f593548ba96e9a1aca0dfaa6696657b416946f24102c5b29655b9f521
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.