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
- Method expert
Price
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.
Business hours: Mon–Fri 9 AM – 5 PM Finnish time (EST/EEST)
Other tests we offer
Cleaning validation of medical devices according to ISO 17664
Irritation testing according to ISO 10993-23
Face mask tests according to EN 14683 for type II and type IIR masks
Biocompatibility evaluation of breathing gas pathways according to ISO 18562
Genotoxicity - Bacterial reverse mutation test (AMES)
Pyrogenicity testing according to ISO 10993-11
Sterility tests according to ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi
Biological evaluation plan (BEP)
Hemocompatibility testing according to ISO 10993-4
Skin sensitization testing according to ISO 10993-10
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