TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES

subpart c - GENERAL HOSPITAL AND PERSONAL USE MONITORING DEVICES

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).