医療用具に残留するエチレンオキサイドに関する研究 (I) : ガスクロマトグラフ法によるエチレンオキサイドの定量について

概要

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Recently, anxieties about toxicity of residual ethylene oxide (EO) in medical devices have been increasing. In response to this, FDA submitted a proposal to regulate EO residual limit in 1978.Investigations on the various conditions for gas liquid chromatographical determination of EO in plastics or fibers were performed along with the regulation.As a result, we recommend to use the following method.25% flexol 8N8 coated on chromosorb WAW is used for column packing for the sake of better resolution. Residual EO is to be extracted by ethanol at 50° to 70℃ for 3 hours, using propylene oxide for internal standard, and 100-1000μl of the gasous phase is to be injected to the column. In this head space method, detection limit of EO was 0.05μg/ml.The amount of residual EO varied according to the sampling site.An obvious difference between polyvinyl chloride tube and silicone tube in absorption and dissipation was obtained.In case of polyvinyl chloride tube, it took more than 7 days to decrease residual EO to 25 ppm, whereas it was only one day in silicone tube.
日本医療機器学会の論文
1982-03-01