Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
医疗器械的生物学评价第7部分:环氧乙烷灭菌残留物
发布日期:
2008-10-13
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.