An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization by Ethylene Oxide is important and expected when demonstrating conformity with the regulations.

These requirements have been supported by a portfolio of standards on:

• Designating products as sterile;
• Validating and routinely controlling the sterilization process;
• Determining whether the sterilization process has any adverse effect on the devices; and
• Maintaining sterility over time with appropriate sterile barrier systems

This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance.