RESTEC recommends that hospitals validate the disinfection cycle, in accordance with their facility sterile quality assurance program.
The chemical indicator is a laboratory grade product from Sigma-Aldrich(St Louis MO) that indicates proper MEC(mg/L) sterilant is deployed for each cycle. This indicator meets ANSI/AAMI/ISO 11140 published standards.
The recommended biological indicator challenge is a >Log 6 bacterial endospore with known sterilization resistance properties. The Geobacillus stearothermophilus (12980) products supplied by MESA Labs (Bozeman MT) meet ANSI/AAMI/ISO 11138 standards for sterilization cycle validation.
The validation process demonstrates a significantly greater microbial efficacy than the FDA guidelines for general disinfection of non-implantable equipment.
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