Performed after manufacturing and before sterilization, this testing determines the microbial load and helps assess the sterility assurance level the appropriate sterilization cycle parameters needed to obtain the required sterility assurance level. Our testing follows ANSI/AAMI/ISO Guideline 11737-1, Sterilization of Medical Devices – Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products, and includes: - Bioburden Validation Testing – Exhaustive Recovery Method - Bioburden Validation Testing – Product Inoculation Method - Bioburden Validation Testing – Bacteriostasis and Fungistasis Testing
