EO Residuals Analysis Spectrophotometry

Residual testing is performed to assure Medical Devices exposed to sterilization procedures are at or below regulatory limits at time of patient use or exposure. Test programs follow the guidelines contained in ANSI/AAMI/ISO 10993-7: 1995. Determinations are made to establish residual dissipation curves and end-point release limits using Gas Chromatography methods. APPLICABLE TEST PROFILES Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol Determinations Simulated - Use Aqueous Extractions Exhaustive Extraction Methods Determinations of interfering chemicals