To ensure the microbiological safety of sterile medical devices, manufacturers undertake various measures. Sterility testing is conducted following established procedures outlined in pharmacopoeias, such as USP <71> and Eur. Ph. 2.6.1, as a release testing to verify the absence of viable microorganisms.
Medical device manufacturers are responsible for understanding the bioburden of the device and validating the sterilization process, aiming for a low Sterility Assurance Level (SAL) with a minimal probability (10-6) of surviving microbes. Each batch must demonstrate sterility, and sterility assurance throughout the product's shelf life is ensured. Compliance with standards like ISO 11137 is essential for sterilization process validation.
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