本技术信息报告为使用合同灭菌设施的医疗制造商和合同灭菌操作提供了补充ANSI/AAMI/IS0 11135系列的附加指南。该文件阐述了ANSI/AAMI/ISO 11135:2014如何适用于在美国销售的设备的环氧乙烷灭菌操作。卫生保健设施环氧乙烷灭菌指南未具体涵盖。

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.