---
kind: "section"
citation: "21 C.F.R. § 880.2800"
title: "21"
number: "880.2800"
heading: "Sterilization process indicator."
url: "https://uscodex.org/cfr/21/880.2800"
---

# §880.2800. Sterilization process indicator.

- (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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.