Biomed Instrum Technol. 2020 Jun 1;54(s1):40-44. doi: 10.2345/0899-8205-54.s3.40.
This article details the evaluation conducted for the potential to reduce ethylene oxide (EO) exposure times using data from currently validated EO sterilization cycles. The candidate cycles used the overkill half-cycle approach detailed in Annex B of ANSI/AAMI/ISO 11135:2014. The overkill half-cycle approach is conservative and has been the method of choice with medical device manufacturers because of its ease of understanding. The analysis presented provides an understanding of the extent of this conservative nature. Based on the analysis, exposure time can be reduced and rapidly implemented. The reduction in the exposure time may improve the product EO residuals and allow for additional time for the EO processing chamber to be utilized and/or for additional off-gassing for the product, if needed.
本文详细介绍了使用当前经过验证的环氧乙烷 (EO) 灭菌循环数据来评估减少 EO 暴露时间的潜力。候选循环采用了 ANSI/AAMI/ISO 11135:2014 附件 B 中详述的过剩半循环方法。过剩半循环方法是保守的，并且由于其易于理解，一直是医疗器械制造商的首选方法。所呈现的分析提供了对这种保守性质的程度的理解。基于分析，可以减少并快速实施暴露时间。减少暴露时间可以改善产品的 EO 残留，并为 EO 处理室的额外使用和/或产品的额外脱气留出更多时间（如果需要）。
