A-A-30165
April 30, 1992
COMMERCIAL ITEM DESCRIPTION
INDICATOR, STERILIZATION, BACTERIAL SPORE
(Steam and Ethylene Oxide Cycles)
The General Services Administration has authorized the use of this commercial item description.
This commercial item description describes a self-contained biological indicator suitable for use in monitoring the performance of steam and ethylene oxide sterilizers to include flash sterilization procedures.
Salient characteristics. The biological indicator shall be self-contained and consist of a flexible plastic vial which has a spore bar impregnated with Bacilus stearothermophilus and Bacilus subtilis, and growth medium. Ethylene oxide and steam process chemical indicators shall be provided each vial and used to provide immediate proof of processing in ethylene oxide or steam cycles. The indicator shall be physically and functionally compatible with Edward Weck No. 150150 ASSERT Dual Purpose Incubator. The indicator shall be used to monitor steam sterilization cycles to include flash and liquid cycles and ethylene oxide sterilization cycles. The indicator is not suitable for use in washer-sterilizers.
Complete and detailed instructions for use of the indicator and of the incubator shall be supplied with each unit.
After sterilization cycle and cooling, the indicator shall be crushed to allow the medium and spores to mix and placed in the proper position in the incubator where it is observed for color change. A distinct positive color change from deep blue to bright yellow indicates presence of the appropriate live spores. No color change after appropriate incubation indicates kill of the spores. Test results for steam cycles may be interpreted at 24 hours and for ethylene oxide at 48 hours.
Not less than 12 months of expiration dating shall remain at time of delivery to the Government.
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