The bioburden test is conducted to determine the total number of viable microrganisms on a medical device or other object. Bioburden testing is completed after manufacturing and prior to sterilization to identify the microbial load on a product. A significant increase in the microbial load can affect the sterility assurance level required by sterilization processes.
ANSI/AAMI/ISO Guideline 11737-1, Sterilization of Medical Devices – Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products
- Bioburden Validation Testing ANSI/AAMI/ISO Guideline 11737-1 Exhaustive Recovery Method
- Bioburden Validation Testing ANSI/AAMI/ISO Guideline 11737-1 Product Inoculation Method
- Bioburden Validation Testing - Bacteriostasis and Fungistasis Testing