AAMI TIR20 pdf free download

AAMI TIR20 pdf free download.Parametric release for ethylene oxide sterilization.
3 Definitions For the purposes of this TIR, the following definitions apply. 3.1 aeration: Part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached. NOTE—Aeration may be performed within the sterilizer and/or in a separate chamber or room. 3.2 aeration area: Either a chamber or a room in which aeration occurs. 3.3 bioburden: Population of viable microorganisms on a raw material, component, finished product, and/or package. 3.4 biological indicator (BI): Inoculated carrier contained within its primary pack providing a known resistance to the relevant process.3.5 calibration: Comparison of a measurement system or device of unknown accuracy to a measurement system or device of known accuracy (traceable to national standards) to detect, correlate, report, or eliminate by adjustment any variation from the required performance limits of the unverified measurement system or device. 3.6 chamber: Enclosed area that accommodates only sufficient product to fill the sterilizer. 3.7 commissioning; installation qualification: Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications and that it functions within predetermined limits when operated in accordance with operational instructions. (See also validation.) 3.8 conditioning: Treatment of product within the sterilization cycle, but prior to sterilant admission, to attain a predetermined temperature and relative humidity. This part of the sterilization cycle may be carried out either at atmospheric pressure or under vacuum. (See also preconditioning.) 3.9 D-value, D 10 value: Time required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions. 3.10 exposure time: Time for which the sterilizer chamber is maintained within the specified range for temperature, sterilant concentration, pressure, and humidity. 3.11 flushing: Procedure by which the sterilant is removed from the load and chamber by either a) multiple alternate admissions of filtered air or inert gas and evacuations of the chamber, or b) continuous passage of filtered air or inert gas through the load and chamber. 3.12 inoculated carrier: Carrier on which a defined number of test organisms has been deposited. 3.13 medical device: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purposes of: a) diagnosis, prevention, monitoring, treatment, or alleviation of disease; b) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap; c) investigation, replacement, or modification of the anatomy or of a physiological process; or d) control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means. 3.14 parametric release: Declaring product as sterile, on the basis of physical and/or chemical process data, rather than on the basis of sample testing or biological indicator results. 3.15 performance qualification: Obtaining and documenting evidence that the equipment as commissioned will produce acceptable product when operated in accordance with the process specification. (See also validation.) 3.16 preconditioning: Treatment of product prior to the sterilization cycle in a room or chamber to attain specified limits for temperature and relative humidity. (See also conditioning.) NOTE—This part of the sterilization cycle may be carried out either at atmospheric pressure or under vacuum. 3.17 preconditioning area: Either a chamber or a room in which preconditioning occurs.AAMI TIR20 pdf download.