A-A-51219A
30 May 1986
SUPERSEDING
A-A-0051219(DM)
15 November 1986
COMMERCIAL ITEM DESCRIPTION
STERILIZATION TEST AMPULES, BACTERIAL SPORE
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers sterilization test ampoules used for monitoring steam and ethylene oxide sterilization.
Salient characteristics:
The ampules shall contain biological/chemical indicators suitable for indicating the efficacy of steam and ethylene oxide sterilization. The ampules shall be suitable for use with an Incubator, Sterilization Indicator, steam, National Stock Number 6640-01-169-0270 and an appropriate incubator which is preset for 370c for use with ethylene oxide exposed indicators. The item shall consist of a friction-fit cap on a clear plastic ampule containing the following:
a) A crushable vial containing a growth medium and a PH indicator;
b) A filter paper disc impregnated with viable Bacillus Stearothermophilus and Bacillus Subtilis, dry bacterial spores adjusted to give pre-determined resistance; and
c) External sterilization indicators that change color during the sterilization process itself (These markings differentiate sterilized from unsterilized ampules and also differentiate between exposure to steam or EtO). The indicator shall respond to steam sterilization at a minimum temperature of 250°F (121°C). The cap shall be capable of being pressed on the ampule. When the cap is unpressed, it shall allow the sterilizing agents to enter the ampule for sterilization.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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