Ensure the safety and compliance of your sterilized medical devices with Ethylene Oxide (EtO) residue testing. Our ISO 10993 compliant testing services detect and quantify residual EtO and its by-products to ensure levels are within safe, permissible limits. Ideal for single-use devices, surgical instruments, and implants, our advanced GC-based analysis supports product release, regulatory approvals, and global market access. Partner with our certified labs for accurate, reliable EtO testing and ensure patient safety with every device.
Ethylene Oxide (EtO) residue testing is a critical safety assessment conducted on medical devices sterilized using EtO gas. While effective for sterilization, residual EtO and its by-products—ethylene chlorohydrin (ECH) and ethylene glycol (EG)—can pose health risks if not properly removed. This test, performed as per ISO 10993 guidelines, measures the concentration of these residues to ensure they remain within permissible limits. EtO testing is essential for product safety, regulatory compliance, and the release of devices such as catheters, syringes, surgical kits, and implants intended for direct or prolonged patient contact.
To detect and quantify residual Ethylene Oxide (EtO), Ethylene Chlorohydrin (ECH), and Ethylene Glycol (EG) remaining on sterilized medical devices.
To protect patients from potential toxic, carcinogenic, or irritant effects caused by EtO residues.
To validate the effectiveness of aeration and degassing procedures after sterilization.
To support product release, batch clearance, and regulatory submissions for domestic and international markets.
To demonstrate compliance with biocompatibility and safety requirements for medical devices intended for invasive or prolonged use.
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