StacksVerified U.S. regulatory reference

21 CFR §880.6860

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).