Sterilization with ethylene oxide is one of the sterilization methods of Medical Devices. It is one of the preferred methods due to the fact that medical plastic materials are heat sensitive with the feature.
Ethylene Oxide, Ethylene Chlorhidrin and Ethylene Glycol detection are performed on the product sterile as a result of full-cycle sterilization. Detection results, biological evaluation of ISO 10993-7 Medical instruments-Part 7: Sterilization with ethylene oxide should be in accordance with the detection limits of remnants.
Ethylene Oxide Residue analysis is carried out according to the following standards.
TS EN ISO 10993-7 Biological evaluation of medical instruments-Part 7: Remnants of sterilization with ethylene oxide