Medical products sterilized by ethylene oxide sterilization should be analyzed for ethylene oxide residue.
Since ethylene oxide has a carcinogenic effect, it should not be above certain limits in medical products.
In the "Medical Device Regulation Appendix-1", the following statements about this subject are included.
“Medical devices should be designed, manufactured and packaged in a way that minimizes hazards in terms of residues and contaminants for patients, people who use, maintain and transport the medical device in accordance with the intended use. Particular attention should be paid to the tissues exposed to the medical device, the duration and frequency of exposure. ”
For this reason, companies that sterilize their products with ethylene oxide must definitely perform ethylene oxide residue analysis at the end of the process.
Ethylene Oxide Residue Test is in our Türkak accredited scope.
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