第32回大会シンポジウム3「リスクアセスメントの現状と展望：レギュラトリーサイエンスへの係わり」
滅菌医療用具の残留エチレンオキサイド許容値の論拠とリスクアセスメント
2004 年 26 巻 2 号 p. 171-175
詳細
2004 年 26 巻 2 号 p. 171-175
Ethylene oxide (EO) gas sterilization is one of the most frequently used sterilization methods in medical device manufacture. However, considering that EO is a genotoxic carcinogen, the allowable limits of the EO residue in medical devices after sterilization have been discussed in the international standardization working group, ISO/TC194/WG11, and adopted as an ISO standard, ISO 10993-7 in 1995. This article describes the rationale of these allowable limits and is especially focused on risk assessment procedures.
