§ 880.2800. Sterilization process indicator.
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/us/cfr/t21/s§ 880.2800·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).
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§ 880.2800
Sterilization process indicator.
Fed. Reg.×2
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