Ethylene oxide (EO) sterilization and sterilization residues by ISO 10993-7

Sterilization residue testing according to ISO 10993-7 is a crucial part of the biocompatibility assessment for medical devices that have been sterilized with ethylene oxide. During the assessment, harmful compounds originating from ethylene oxide sterilization are analyzed to ensure that the device is safe to use after sterilization. Testing is required for the regulatory approval of applicable new medical devices in the EU (under the MDR) and the US (510(k) submission to the FDA).

Ethylene oxide sterilization can be used when steam sterilization is not appropriate for the device. Ethylene oxide (EO) and ethylene chlorohydrin (ECH) are irritating and toxic chemicals, and for this reason, it has to be ensured that residue levels cause minimal risk to the patient during normal product use. ISO 10993-7 sets the maximum daily doses for EO and ECH in mg/d, based on the device's exposure duration category (limited, prolonged, or permanent). Residual amounts shall not exceed these maximums.

During the assessment, the product is extracted with water and the amount of ethylene oxide and ethylene chlorohydrin is determined chromatographically. Extractions are made until the cumulative exposure does not increase.

The displayed example price covers both ethylene oxide sterilization and analysis of sterilization residues (EO and ECH). Price includes a 6-hour sterilization cycle for one euro pallet (80x120x190cm) with 3 extractions.

Please ask for a quote for your medical device.