Why is Ethylene Oxide used for the sterilization of medical devices?
Ethylene Oxide sterilization is one of the most effective and efficient due to its ability to penetrate the surfaces of medical devices and packaging without causing damage. In addition to the advantage over materials that cannot withstand traditional heat and steam sterilization methods.
What is Ethylene Oxide residue analysis?
We guarantee regulatory compliance and improve product safety
Este análisis especializado es vital para garantizar la integridad de los dispositivos médicos. By identifying and quantifying Ethylene Oxide waste, we ensure regulatory compliance, improve product safety, and build trust in the healthcare community.
This comprehensive analysis underscores the commitment to patient well-being and maintains the highest standards of safety and effectiveness in the industry.
Why is this analysis important?
These residues can cause varying degrees of illness.
This analysis is essential for the safety of medical devices. The ability to absorb, retain and release Ethylene Oxide depends on the sterilized materials. These residues can cause various types of diseases and tissue damage to patients.
ISO 10993-7 Standard
The ISO 10993-7 standard provides the necessary guidelines to evaluate the biocompatibility of medical devices considering the quantification of Ethylene Oxide and secondary product residues.
This standard ensures patient safety by establishing safe limits for these compounds in medical devices.
Ensure the safety of your products with this important analysis and other services we offer to the medical devices industry.
Methods for ethylene oxide residue analysis
- Simulated use extraction: water
- Exhaustive extraction: thermal or solvent extraction
