EO & ECH Residual Test
Ethylene oxide gas (EO) is a flammable and colorless gas commonly used in medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization (i.e., ISO 10993-7:2008) and Japanese Industrial Standards (i.e., JIS T 0993-7:2012).
Physical and/or Chemical information
Dependent on the type of medical device
(samples must be transported on dry ice to the test unit)
at least 3 non-sterile test item;
at least 3 test item after EO sterilization process;
ISO 10993-7 is a part of the ISO 10993 series, which outlines the biological evaluation of medical devices. Specifically, ISO 10993-7 focuses on the testing of ethylene oxide sterilization residuals. Ethylene oxide (EO) is a commonly used sterilization method for medical devices, as it can effectively kill all kinds of microorganisms.
The content of ISO 10993-7 includes guidelines for assessing the biological safety of medical devices that have been sterilized using ethylene oxide. The standard provides information on the potential hazards associated with residual ethylene oxide and its by-products that may remain on the device after sterilization.
Testing according to the guidelines of ISO 10993-7 is essential for several reasons:
- User Safety: Ensuring that medical devices are free from harmful levels of ethylene oxide residuals is crucial for the safety of patients, healthcare professionals, and other users.
- Regulatory Compliance: Many regulatory bodies require adherence to ISO 10993 standards as part of the regulatory approval process for medical devices. Compliance with these standards demonstrates that the device has undergone thorough testing to assess its biocompatibility.
- Risk Mitigation: Testing for ethylene oxide residuals helps identify and mitigate potential risks associated with the use of the medical device, contributing to the overall risk management process.
- Contribute: Following ISO 10993-7 guidelines contributes to the quality assurance of medical devices by ensuring that they meet established safety standards.
ISO 10993-7 provides a framework for evaluating the biological safety of medical devices sterilized with ethylene oxide. Adhering to the guidelines of this standard is crucial to ensure the safety, regulatory compliance, and quality of medical devices in the healthcare industry.
European Biomedical Institute is fully accredited to perform this type of study by the ISO 17025 certification.