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45 FR 69682, Oct. 21, 1980, unless otherwise noted.
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Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.
(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).