AAMI ST77 pdf free download

AAMI ST77 pdf free download.Containment devices for reusable medical device sterilization.
3 Definitions and abbreviations
For the purpose of this standard, the following definitions apply.
3.1 aseptic presentation: Maintaining the sterility of the contents as a sterilized package is opened and the contents are removed.
3.2 bIological Indicator (BI): Test system containing viable microorganisms providing a defined resistance to the specified sterilization process. (See ANSI/AAMI/ISO 11138-1.)
NOTE 1—According to FDA, tma 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 stenhization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.’ [21 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 not al 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 chemical indicator (Cl): Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or used in specific tests of sterilization equipment. (See
ANSI/AAMI/ISO 11140-1)
3.4 container, reusable rigid sterilization: Sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents.
NOTE—The system generally consists of a bottom or base with carrying handles and a lid that is secured to the base by means of a latching mechanism. A basket or tray to hold instruments or other items to be sterilized is placed inside. A filter or valve system is incorporated into the lid and/or base to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport.
3.5 containment device: Reusable rigid sterilization container, instrument organizer, and any reusable accessories intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization.
NOTE—Although containment devices are primarily intended to contain reusable medical devices for sterilization, they may also contain nonsterile devices intended for one-time use after sterilization.
3.6 cool-down: Period of time after steam sterilization during which containment devices are allowed to cool on the sterilizer rack outside the sterilizer before handling.
NOTE—The time allowed for cool-down should take into account the sterilizer being used, the design of the device being sterilized, the temperature and humidity of the ambient environment, and the type of containment device and/or wrap used, or the user should be instructed that the load may be released following direct, non-contact measurement of its temperature showing that the temperature has reached ambient (room) temperature.
3.7 cycle: Defined sequence of operational steps designed to achieve sterilization and carried out in a sealed chamber.
3.8 cycle, ethylene oxide: Type of gaseous chemical sterilization cycle in which the four process variables are ethylene oxide (EO) gas concentration, exposure time, temperature, and relative humidity.
3.9 cycle, hydrogen peroxide gas with plasma: Type of gaseous chemical sterilization cycle in which the four process variables are hydrogen peroxide concentration, time, temperature, and gas plasma power level.
3.10 cycle, hydrogen peroxide gas without plasma: Type of gaseous chemical sterilization cycle in which the three process variables are hydrogen peroxide concentration, time, and temperature.AAMI ST77 pdf download.