Sterility Testing of Medical Devices: An Overview

A sterile medical device is one that is free from viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for Quality Management Systems (QMS) may have microorganisms present on and/or within them prior to sterilization (non-sterile products). The purpose of sterilization is to inactivate the microbiological contaminants to transform the devices from non-sterilized to sterilized. Sterility testing of medical devices is required during the sterilization validation process and routine release testing.