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Chemical indicator
A device to monitor the sterilization process that changes color or form with exposure to one or more of the physical conditions within the sterilizing chamber (e.g., temperature, steam). Chemical indicators are intended to detect potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer. A “pass” response does not verify that the items are sterile.
Chemical sterilant
Chemicals used for the purpose of destroying all forms of microbial life including bacterial spores.
Cleaning
The removal of visible soil, organic and inorganic contamination from a device or surface, using either the physical action of scrubbing with a surfactant or detergent and water or an energy-based process (e.g., ultrasonic cleaners) with appropriate chemical agents.
Colony-forming unit
(CFU): the minimum number of separable cells on the surface of or in semi-solid agar medium which gives rise to a visible colony of progeny is on the order of tens of millions. CFUs may consist of pairs, chains, and clusters as well as single cells and are often expressed as colony-forming units per milliliter (CFU/ml).
Contaminated
State of having been in contact with microorganisms. As used in health care, it generally refers to microorganisms capable of producing disease or infection.
Control biological indicator
A biological indicator from the same lot as a test indicator that is left unexposed to the sterilization cycle and then incubated to verify the viability of the test indicator. The control indicator should yield positive results for bacterial growth.
Creutzfeldt-Jakob disease
 (CJD): a degenerative neurological disorder of humans thought to be transmitted by abnormal isoforms of neural proteins called prions. CJD is one of a group of related diseases known as transmissible spongiform encephalopathies (TSEs).
Critical
The category of medical devices or instruments that are introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body (e.g., surgical scalpel) These items are so called because of the substantial risk of acquiring infection if the item is contaminated with microorganisms at the time of use.

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