AAMI ST91:2021
Liquid chemical sterilization can be used to process semi-critical and critical heat sensitive endoscopes. Liquid chemical sterilization is different than thermal and gas (or vapor) low temperature sterilization. Liquid chemical sterilization is able to achieve a 6-log 10 kill of the appropriate bacterial spore shown most resistant to the process in a full cycle, and a SAL cannot be determined. The FDA recommends that liquid chemical sterilization be used for heat sensitive, critical medical devices only when terminal sterilization methods are not feasible or not available. The information in the literature suggests that treatment with liquid chemical sterilants may not necessarily ensure the same sterility assurance as terminal sterilization using thermal or gas/vapor low temperature sterilization methods (Rutala and Weber, 2008 [283]; Rutala and Weber, 2016 [281]). Devices are not wrapped during processing and may not be contained adequately after processing in a liquid chemical sterilant, and there is no assured way to maintain sterility after the devices are processed.