Biological evaluation of medical devices-Ethylene oxide sterilization residuals
医疗器械的生物学评价
发布日期:
2022-01-26
ISO 10993的本部分规定了单个环氧乙烷灭菌医疗器械中残留环氧乙烷(EO)和乙烯氯醇(ECH)的允许限值、EO和ECH的测量程序,以及确定符合性的方法,以便释放器械。资料性附录中还包括其他背景信息,包括说明本文件应用方式的指南和流程图。包含以下内容:BS EN ISO 10993-7:2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes.Incorporates the following:BS EN ISO 10993-7:2008