ISO 10993-7:2008 医疗器械的生物学评价 第7部分：环氧乙烷灭菌残留量

标准编号：ISO 10993-7:2008

中文名称：医疗器械的生物学评价 第7部分：环氧乙烷灭菌残留量

英文名称：Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

发布日期：2008-10

标准范围

ISO 10993-7:2008规定了单个环氧乙烷（EO）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，包括指南和显示标准应用方式的流程图。ISO 10993-7:2008不包括未与患者接触的EO灭菌设备（例如体外诊断设备）。

ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

标准预览图