A-A-51847B
Indicators designed for use in steam sterilization procedures shall include or show parameters of steam, time, and temperature. Indicators showing safe or accept indicate parameters necessary to achieve steam sterilization have been met or exceeded.
Indicators designed for use in 12% ethylene oxide/88% Freon sterilization procedures shall indicate or show parameters of EtO concentration, time, temperature, and relative humidity. Indicators showing safe or accept indicate parameters necessary to achieve EtO sterilization have been met or exceeded.
Indicators shall removed from the sterilized package and interpreted by the end user who must decide the product sterilized is safe for use. Aeration of EtO sterilized items and prolonged storage of steam and EtO sterilized items shall have no affect on the indicator.
Complete and detailed instructions for the use and interpretation of indicators shall be provided with each unit.
Indicators covered by this document shall be of the following styles:
Style A – For EtO Sterilization. Color change from Reject to Accept, 1000’s
Style B - For EtO Sterilization. Color change from Unsafe to Safe, 2000’s
Style C - For Steam Sterilization. Color change from Reject to Accept, 1000’s
Workmanship. The indicators shall be free from defects which detract from their appearance or impair its serviceability.
Unit. Package (PG). One package containing one thousand indicators for style A and C or one package containing two thousand indicators for style B, as specified, constitutes one unit.
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