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Sterilizing medical devices using ethylene oxide (EO) is a widely used practice due to its compatibility with various materials. However, a potential drawback of EO sterilization is the residual substances it can leave on the processed devices. The following residues may be present after processing:
<ol>
<li>Ethylene Oxide (EO) residue: This is the residue that may remain after the sterilization process is complete.</li>
<li>Ethylene Chlorohydrin (ECH) residue: When EO comes into contact with free chloride ions, it can form ECH as a residue.</li>
<li>Ethylene Glycol (EG) residue: If EO comes into contact with water, it can form EG as a residue.</li>
</ol>
These residues can pose risks to end-users or patients. Therefore, it is crucial for all devices to adhere to the limits specified in the AAMI 10993-7 standard. The specific limits vary depending on the intended use of the device and are categorized into three main groups: Limited Use, Prolonged Use, and Permanent Use. Additionally, there are specific limits for certain device categories. Devices without patient contact are not required to meet this standard. The table below, extracted from the AAMI 10993-7 standard, provides an overview of the different categories and their corresponding limits.
Devices that come into direct contact with surfaces or are implantable must also meet an additional set of criteria known as the Tolerable Contact Limit (TCL). The purpose of this limit is to prevent localized irritation caused by the release of EO or ECH from the device. The TCL is calculated based on the device's surface area and the levels of EO and ECH residues to determine if irritation is likely to occur.

Ethylene Oxide (EO Or EtO) Residuals After Sterilization

Publish Time：2023-11-01