AAMI ST79:2017 Worksheet

Diagnostic test of a dynamic-air-removal steam sterilizer’s ability to remove air from the chamber and prevent air re-entrainmen
Pack used in qualification, installation, and routine quality assurance testing of hospital sterilizers.
Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or used in specific tests of sterilization equipment
Time required for the parameters necessary for the selected sterilization cycle to be reached.
Water that is extensively treated (usually by a multistep treatment process that could include a carbon bed, softening, deionization [DI], and reverse osmosis [RO] or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water; a final submicron filtration could also be part of the treatment process. This water is mainly used for the final rinse or for steam generation
Total elapsed time of a sterilization cycle from the time the process is initiated until the cycle is completed. Cycle time can include come-up time, exposure time, come-down time, cooling or drying time, and, in prevacuum sterilizers, pre- and post-vacuum time
Process that kills all microbial organisms but not necessarily large numbers of bacterial spore
Medical gas that falls under the general requirements for medical gases as defined by NFPA 99 (Health care facilities code), is not respired, is compliant with the ANSI/ISA 7.0.01 (Quality standard for instrument air), and is filtered to 0.01 microns, free of liquids and hydrocarbon vapors, and dry to a dew point of -40ºC (-40ºF).
Device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware (e.g., basins, medicine cups), and other medical devices [21 CFR 880.6991(a)].
Process designed to provide a particular level of microbial lethality (kill). Depending on the level of decontamination needed, this process could be a disinfection process or a sterilization process. The type and level of microbial kill achieved depends on factors such as the type and population of microorganisms present, the type of antimicrobial agent, the concentration of the antimicrobial agent, the exposure time, and the exposure temperature. When used for decontamination purposes, a microbicidal process does not necessarily yield an item that is safe for patient use.