21 CFR § 880.2800 - Sterilization process indicator.
---
identifier: "/us/cfr/t21/s880.2800"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.2800 - Sterilization process indicator."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.2800"
section_name: "Sterilization process indicator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---
# 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).