StacksVerified U.S. regulatory reference

21 CFR §880.6880

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
  2. (b)Classification. Class II (performance standards).