Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
医疗器械的生物学评估 - 第7部分:环氧乙烷灭菌残留(ISO 10993-7:2008)
发布日期:
2008-10-15
实施日期:
2008-10-15
ISO 10993-7:2008规定了各种EO灭菌医疗器械中残留环氧乙烷(EO)和氯乙醇(ECH)的允许限值,EO和ECH的测量程序以及确定依从性的方法,以便器件释放。额外的背景,包括指南以及如何应用标准的流程图也包括在资料性附件中。
没有患者接触的EO灭菌装置(例如,体外诊断装置)未被ISO 10993-7:2008涵盖
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.