ANSI ADA AAMI ST55 pdf free download

ANSI ADA AAMI ST55 pdf free download.Table-top steam sterilizers.
2 Normative references The following documents contain provisions that, through reference in the text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. 2.1 American Society of Mechanical Engineers. Boiler and pressure vessel code. New York: ASME, 2007 (with current amendments). 2.2 Association for the Advancement of Medical Instrumentation. 5ed. Hospital steam sterilizers. ANSI/AAMI ST8:2008. AAMI, 2009. 2.3 Association for the Advancement of Medical Instrumentation. Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes. ANSI/AAMI/ISO 1 1 1 38-3:2006. Arlington (VA): AAMI, 2006. 2.4 Association for the Advancement of Medical Instrumentation. Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs. ANSI/AAMI/ISO 1 1 1 40- 5:2007. Arlington (VA): AAMI, 2007. 2.5 Association for the Advancement of Medical Instrumentation. Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. ANSI/AAMI/ISO 1 7665-1 :2006. Arlington (VA): AAMI, 2006. 2.6 National Fire Protection Association. National electrical code. ANSI/NFPA 70. Current Edition. Quincy (MA): NFPA.2.7 Underwriters Laboratories. Electrical equipment for measurement, control, and laboratory use—Part 1: General requirements. UL 61 01 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. IEC 61 01 0-2-040. Current edition. Geneva (Switzerland): IEC. 2.9 Committee for European Standardization. Small steam sterilizers. EN 1 3060:2004+A2:201 0. Brussels (Belgium): CEN, 2010.3 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 manufacturer’s authorized representative. 3.4 certified laboratory standards: Standards traceable to the National Institute for Standards and Technology (NIST) 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. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.” [21 CFR 820.72(b)(1 )] 3.5 chamber: Portion of the sterilizer 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.ANSI ADA AAMI ST55 pdf download.