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EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

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.

This whitepaper was written by Thor Rollins, Gregory Grams, Mike Padilla, Peter Strain and Erik Haghedooren.

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