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<a href="https://www.hzbocon.com/product-list/ethylene-oxide-sterilizer">Ethylene oxide (EO)</a> is a gas used to sterilize medical devices, especially those not suitable for traditional high-heat sterilization. As medical devices must adhere to specific sterility standards before use, ethylene oxide sterilization serves as a simple, effective, and common alternative. However, both ethylene oxide and its byproducts, ethylene chlorohydrin (ECH) and ethylene glycol (EG), are toxic to the human body. Therefore, all EO sterilized medical devices must comply with regulatory limits for EO, ECH, and EG residuals. Here are ten essential details about ethylene oxide sterilized medical devices:
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EO Residual Testing Exemption: Certain EO sterilized devices without patient contact, such as in vitro diagnostic devices, fall outside the ISO 10993-7 EO residual limits standard. Only devices that are EO sterilized and have patient contact require EO residual testing.
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Side Effects: Ethylene oxide and its residual components can cause irritation, organ damage, mutagenicity, and carcinogenicity, necessitating set limits for EO residuals in medical devices.
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Assessment of Residuals: Typically, EO and ECH residuals are assessed during EO residual testing. While EG poses minimal risk during regular use, it is mandatory to meet specific limits for EO and ECH.
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Concern for EG Limits: For devices in contact with intravenous blood flow, particularly for extended periods, tests should be conducted to measure the hydrolysis of EO to EG to prevent hemolysis.
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Categorizations: EO sterilized devices fall into three categories based on exposure: limited, prolonged, or permanent.
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Multi-Device Systems: In multi-device systems, EO limits apply to each device contacting a patient, necessitating individual EO residual testing for each device.
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Special EO Limits: Specific medical devices, such as blood cell separators, intraocular lenses, and blood purification devices, have special EO residual limits.
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Tolerable Contact Limits: Surface-contacting devices and implants require tolerable contact limits in addition to EO and ECH limits based on device category.
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Extraction Methods: Two extraction methods, simulated use and exhaustive, are used for EO residual testing based on the device's intended use.
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Shipping Considerations: Quick removal of product samples from an EO sterilized batch following a cycle can impact their representativeness. Samples should rest with the entire set of sterilized devices before shipping, and shipment details should include the date and time of sample extraction following the EO sterilization cycle.
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10 Things To Know About Ethylene Oxide (EO) Sterilized Medical Devices

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Ethylene oxide (EO) is a gas used to sterilize medical devices, especially those not suitable for traditional high-heat sterilization. As medical devices must adhere to specific sterility standards before use, ethylene oxide sterilization serves as a simple,

10 Things To Know About Ethylene Oxide (EO) Sterilized Medical Devices

Publish Time：2023-12-11