医療用具のエチレンオキサイドガス滅菌 : 特に滅菌効果と残留エチレンオキサイドおよび二次生成物濃度について

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For sterilized disposable medical devices, the ethylene oxide gas is used as a sterilization in most cases. When this sterilization method is used, ethylene oxide (EO) and its secondary products, i.e.; ethylene chlorohydrin (ECH) and ethylene glycol (EG), remain in the medical device after its sterilization. If their concentration is high, these residues are liable to cause a hemolytic activity and dermal or mucous membrane irritability in human bodies. For this reason, FDA submitted a proposal to regulate EO, ECH and EG residual limits in 1978.In view of the above, our studies have been made to examine the conditions of EO sterilization from the viewpoints of the sterilization effect and the residual chemical substances and, to find out the optimum sterilization conditions.Further, an aerator has been fabricated for the exclusive purpose of redicing, within a breif period, the concentration of EO and other substances remaining in the medical devices after their sterilization and the condition for its use have been examined by using this aerator.As the result, it has been found out that a satisfactory sterilization effect can be obtained under the sterilization conditions of an EO gas concentration of 500mg/liter, a sterilizing temperature of 55 to 60℃ and a sterilizing time of two hours, and under these conditions the concentration of residual susbtances such as EO can be made comparatively lower.It has been also clarified that the minimum required aeration conditions by using the exclusive-use aerator are a temperature of 55 to 60℃ and an aeration time of about 24 hours.
日本医療機器学会の論文
1982-01-01

医療用具のエチレンオキサイドガス滅菌 : 特に滅菌効果と残留エチレンオキサイドおよび二次生成物濃度について

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