最后包括2010年1月的勘误表。AAMI/ISO 10993-7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。其他背景，包括指南和流程图 本文件适用，也包含在资料性附录中。EO消毒设备 无患者接触（如体外诊断设备）不在本标准范围内。

Includes a January 2010 erratum at the end.AAMI/ISO 10993-7 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, is also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.