Steam Sterilization Validation
1. Turnaround time: to be determined upon study parameters
2. Sample Requirements: at least 5 samples
AAMI TIR12 & AAMI ST79 & AAMMI ST77
& ISO 17664 & ISO 17665 & ISO 11135 & FDA Guidance
The purpose of this test is to validate the sterilization procedure described in the reusable medical device IFU (instructions for use). Sterility is the absence of viable microorganisms and typically requires a SAL (sterility assurance level). Methodology involves challenging the medical device with a suspension of bacterial spores or other robust Biological Indicators (BI) and subjecting the contaminated device to the sterilization procedure. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. Our laboratory can validate the following modalities for sterilization: steam/heat and ethylene oxide (EO).