ΚΛΙΝΙΚΕΣ ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ ΟΔΗΓΙΕΣ • ΑΠΟΣΤΕΙΡΩΣΗ relatively resistant to disinfectant and sterilant activity and drying conditions (specifically in the genera Bacillus and Clostridium). Spore strip: paper strip impregnated with a known population of spores that meets the definition of biological indicators. Steam quality: steam characteristic reflecting the dryness fraction (weight of dry steam in a mixture of dry saturated steam and entrained water) and the level of noncondensable gas (air or other gas that will not condense under the conditions of temperature and pressure used during the sterilisation process). The dryness fraction (i.e., the proportion of completely dry steam in the steam being considered) should not fall below 97%. Steam sterilisation: sterilisation process that uses saturated steam under pressure for a specified exposure time and at a specified temperature, as the sterilising agent. Steam sterilisation, dynamic air removal type: one of two types of sterilisation cycles in which air is removed from the chamber and the load by a series of pressure and vacuum excursions (prevacuum cycle) or by a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush-pressure-pulse cycle). Sterile or Sterility: state of being free from all living microorganisms. In practice, usually described as a probability function, e.g., as the probability of a microorganism surviving sterilisation being one in one million. Sterility assurance level (SAL): probability of a viable microorganism being present on a product unit after sterilisation. Usually expressed as 10–6; a SAL of 10-6 means ≤1/1 million chance that a single viable microorganism is present on a sterilised item. A SAL of 10-6 generally is accepted as appropriate for items intended to contact compromised tissue (i.e., tissue that has lost the integrity of the natural body barriers). The steriliser manufacturer is responsible for ensuring the steriliser can achieve the desired SAL. The user is responsible for monitoring the performance of the steriliser to ensure it is operating in conformance to the manufacturer’s recommendations. Sterilisation: validated process used to render a product free of all forms of viable microorganisms. In a sterilisation process, the presence of microorganisms on any individual item can be expressed in terms of probability. Although this probability can be reduced to a very low number, it can never be reduced to zero. Sterilisation area: area of a health-care facility designed to house sterilisation equipment, such as steam ethylene oxide, hydrogen peroxide gas plasma, or ozone sterilisers. Steriliser: apparatus used to sterilise medical devices, equipment, or supplies by direct exposure to the sterilising agent. 65
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