The categories of medical devices that have been identified are based on the duration they are used on the final patients and will determine the maximum allowable levels of such EO residues in the final device. The ISO 10993–7 (2008) on Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals is the guiding document generally accepted for the evaluation of EO residuals in medical devices.

For the assessment of EO residuals in medical devices, this guideline documents the authorized limit of each residue, the suggested technique of extracting and testing the residues, and comprehensive quality control on the analytical procedure.

After performing an ethylene oxide sterilization process, a device may still contain considerable concentration of residues for a variety of causes.

Material: Some compounds will absorb and hold onto gas molecules more so than others. Natural compounds with high absorption capacities include cellulose and cotton. Some plastic materials have also demonstrated a high rate of absorption when subjected to EO processing.

Packaging: Breathable packaging, such Tyvek or medical-grade paper, are necessary for EO processing in order to let gas molecules to flow through. The gas won’t be able to penetrate the breathable barrier as effectively if the packaging has a restricted or blocked surface area (like a big sticky label).

Volume, density, and general load arrangement of the load on a pallet can all be considered.

Medistri will perform Ethylene Oxide Residual Analysis in our GMP Accredited In-House laboratory in Switzerland (also certified with ISO 17025) to analyse and demonstrate the safety of your sterile medical device.