21 C.F.R. § 880.6880
Steam sterilizer.
Cite as 21 C.F.R. § 880.6880 (2026)
(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.
(b)
Classification.
Class II (performance standards).