Ethylene Oxide Residue Analysis

Ethylene Oxide Residue Analysis is performed to detect chemical residues remaining on the product after the ethylene oxide sterilization process, which is one of the sterilization methods of medical devices. This method, which is especially preferred in heat-sensitive medical plastic materials, provides effective sterilization, while controlling the remaining residues is of great importance.

 

The following components are detected on the product with ethylene oxide residue analysis:

  • Ethylene Oxide (EO)
  • Ethylene Chlorhydrin (ECH)
  • Ethylene Glycol (EG)

In the analyses performed, the results must comply with the ISO 10993-7 standard. This standard specifies acceptable residue limits after ethylene oxide sterilization for the biological evaluation of medical devices.

Ethylene Oxide Residue Analysis is performed according to the following standard:

  • TS EN ISO 10993-7: Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residues

 

Laboratory Service for Ethylene Oxide Residue Analysis
Do you want to have residue analysis performed on your medical devices after the sterilization process with ethylene oxide? Our laboratory has all the technical equipment and expertise required to detect Ethylene Oxide (EO), Ethylene Chlorhydrin (ECH) and Ethylene Glycol (EG) residues in accordance with the ISO 10993-7 standard