ANSI AAMI ST55 pdf free download
ANSI AAMI ST55 pdf free download.Table-top steam sterilizers.
3 Definitions, symbols, and abbreviations
For the purposes of this standard. the following definitions apply.
3.1 accuracy: Extent to which the measured value of a quantity differs from the true value of the quantity measured.
3.2 cassette sterilizer: Sterilizer that uses a removable cassette as both the container to hold the items to be sterilized and the vessel that contains the sterilant (steam) for processing.
3.3 certIfication: Formal report of test results attesting to the satisfactory performance of a sterilizer and accompanied by a statement to this effect signed by the manufacturers authorized representative.
3.4 certified laboratory standards: Standards traceable to the National Institute for Standards and Technology (N 1ST) or other recognized industry or government standards.
NOTE—The Quality System regulation states that “if national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. It no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.” [21 CFR 820.72(b)(1)J
3.5 chamber: Portion of the stefllizer in which items are processed and that is sealed off from the ambient environment when the door is closed.
3.6 control-set temperature: Arbitrary temperature that serves as the operating reference for the sterilizer control system so that the chamber temperature will remain within the required range around the selected sterilization exposure temperature.
3.7 control system (sterilizer): System that regulates the sterilization conditions within a sterilization chamber.
3.8 cycle: Defined sequence of operational steps designed to achieve sterilization and carried out in a sealed chamber.
3.9 cycle, steam sterilization, dynamic-air-removal type: One of two types of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions (prevacuum cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush pressure- pulse (SFPPJ cycle).
3.10 cycle, steam sterilization, gravity-displacement type: Type of sterilization cycle in which Incoming steam displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber.
NOTE—Typical operating temperatures are 121 °C to 123 °C (250 F to 253 F) and 132 °C to 135 °C (270 °F to 275 CF).
3.11 D value: Time or dose required to achieve inactivation of 90 % of a population of a test microorganism under
stated conditions.
3.12 dryIng time: Time required to dry steam-sterilized items before they are handled.
3.13 handle: As the term is used in this standard, a hand-operated device used to open and close the chamber door or to lock or unlock the chamber. The term may also be applied to devices used to control the flow of steam, water, or power to the sterilizer.
3.14 holding time: Period for which the temperature at the control location for the sterilizer is held within the sterilization temperature band.
NOTE—Holding time follows immediately after the preconditioning phase. The length of the holding time is related to the sterilization temperature.
3.15 jacket: Portion of the sterilizer surrounding and affixed to the chamber through which steam is circulated and that functions to help maintain temperature in the chamber.
3.16 noncondensable gas: Air or other gas that will not liquefy under the conditions of a saturated steam process.
ANSI AAMI ST55 pdf download.
