ISO 10993 – 7
Many medical devices require some form of terminal sterilization and often ethylene oxide is chosen because it is effective and does not adversely affect many of the materials used to make medical devices. The use of ethylene oxide as a sterilant obligates companies to demonstrate that ethylene oxide (ETO) and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG) are removed from the product and packaging.
Pace Analytical Life Sciences (PLS) offers analytical ethylene oxide residual testing of terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods:
- Gas Chromatography with Solid-Phase Micro Extraction
- Gas Chromatography using headspace sampling for ethylene oxide (ETO)
- Gas Chromatography water extracts for ethylene oxide (ETO)
- Gas Chromatography water extracts for ethylene chlorohydrin (ECH) and ethylene glycol (EG)
Download Evaluation of Medical Devices literature.