21 C.F.R. § 880.2800 Sterilization process indicator.
Title 21 - Food and Drugs
(a) Biological sterilization process indicator—(1) Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. (2) Classification. Class II (performance standards). (b) Physical/chemical sterilization process indicator—(1) Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. (2) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart C—General Hospital and Personal Use Monitoring Devices
§ 880.2800 Sterilization process indicator.
