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

Medical devices sterilized with ethylene oxide are tested according to ISO 10993-7 to ensure that residual chemical concentrations are not high enough to make normal product use unsafe. Testing is required for the regulatory approval of applicable devices in the EU (under the MDR) and the US (510(k) submission to the FDA).

Ethylene oxide can be used when steam sterilization is not appropriate for the device. ISO 10993-7 sets maximum daily doses for ethylene oxide (EO) and ethylene chlorohydrin (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 EO and ECH 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.

Suitable sample matrices
Medical devices
Required sample quantity
150 cm2
Typical turnaround time
4 weeks after receiving the samples
Available quality systems
Accredited test method
Standard

Price

Typical price (Excl. VAT):
4,230 €

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

Questions? We're happy to help.

Questions? We're happy to help.

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Answering the following questions helps us prepare an offer for you faster:

  • What is your medical device's intended use, body contact site, and contact duration?

  • Do you need additional biocompatibility tests for the device in addition to ISO 10993-7?

  • Do you need the tests for R&D purposes or submission to officials?

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