[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.2800]

[Page 412]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880_GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
     Subpart C_General Hospital and Personal Use Monitoring Devices
 
Sec. 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).