Sterility test by ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi

Sterility testing measures the growth of microorganisms on a product after the product has been sterilized. ISO 11737-2 is a harmonized standard for evaluating the sterility of medical devices by the EU Medical Device Regulation, as well as an FDA-recognized consensus standard for supporting 510(k) submissions.

A sterile device or product is free from viable microorganisms. The purpose of sterilization is to inactivate microbiological contaminants to transform devices from a non-sterilized to a sterilized state. Sterility can be assessed when defining, validating, or maintaining a sterilization process.

Testing by ISO 11737-2 includes method validation by determining the initial bacterial count of control suspensions and testing the suitability of the culture mediums for aerobic and anaerobic bacteria and fungi. Also, the suitability of the test for the specific product is assessed.

During testing, the growth of aerobic bacteria, anaerobic bacteria, and fungi (yeasts and molds) on the product is observed. For this reason, 3 replicate sample specimens are needed. The results are given as negative (no growth observed) or positive (growth observed), and the price includes one result per micro-organism per product.