Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compatible with other sterilization techniques, such as radiation. However, because of the potentially harmful effects of exposure to EO residue to patients, it is crucial to ensure the levels of EO residue meet the standards defined by ISO 10993-7:2008 by using validated testing methods. This paper will provide an overview of best practices for demonstrating compliance with that standard, and for demonstrating products sterilized via EO gas are safe for use.
EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...