AAMI ST8 pdf free download

AAMI ST8 pdf free download.Hospital steam sterilizers.
2.5 European Committee for Standardization. Sterilization—Steam sterilizers—Large sterilizers. EN 285. Current edition. Brussels: CEN.
2.6 National Fire Protection Association. National Electrical Code. NFPA 70. Current edition. Quincy (MA):
NFPA.
2.7 Underwriters Laboratories. Electrical equipment for measurement, control, and laboratory use—Part 1:
General requirements. UL 6101 0-1. Current edition. Northbrook (IL): UL.
NOTE—For product conformity assessments, the Part 2 standard for steam sterilizers (Normative Reference 2.8) is to be used in conjunction with the applicable Part 1 standard for electrical equipment for laboratory use (Normative Reference 2.7).
2.8 International Electrotechnical Commission. Electrical equipment for laboratory use—Part 2: Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory processes. lEG
61010-2-040. Current edition. Geneva: IEC.
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 bIological Indicators (Bis): Test systems containing viable microorganisms providing a defined resistance to a specified sterilization process.
NOTE 1 —According to FDA, a biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization. in or on a camer and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.” L21 CFR 880.2800(a)(1)j
NOTE 2—Biological indicators are intended to demonstrate whether or not the conditions were adequate to achieve sterilization. A negative BI does not prove that all items in the load are sterile or that they were all exposed to adequate sterilization conditions.
NOTE 3—See ANSI/AAMI/ISO 14161 for information on the selection, use, and interpretation of biological indicators.
3.3 calibrated standards: Standards traceable to national or international standards.
NOTE—The Quality System Regulation (QSR) states that “if national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.” [21 CFR 820.72(b)(1)1
3.4 certification: Formal report of test results attesting to the satisfactory performance of a sterilizer and accompanied by a statement to that effect signed by the manufacturer’s authorized representative.
3.5 chamber: Portion of the sterilizer in which items are processed and which is sealed oft from the ambient environment when the door is closed.
3.6 chemIcal Indicators (Cis): Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment.
NOTE—See ANSI/AAMI/ISO 15882 for information on the selection, use, and interpretation of chemical indicators.
3.7 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.
3.8 control system (sterilizer): System that regulates the sterilization conditions within a sterilization chamber.
3.9 cycle: Defined sequence of operational steps designed to achieve sterilization and carried out in a sealed chamber..AAMI ST8  pdf download.