本AAMI技术信息报告（TIR）为增强信息和 ANSI/AAMI/ISO 11135:1994《医疗器械》中提供的参数释放要求？ 环氧乙烷（EO）灭菌的验证和常规控制。本TIR旨在提供帮助 那些使用ANSI/AAMI/ISO 11135:1994来理解 开发并验证符合标准的环氧乙烷灭菌工艺？s 参数化发布的要求。本TIR还为选择 在给出替代方案的情况下采取适当的行动。本TIR中的指南仅限于 本标准中专门针对参数发布的章节。

This AAMI technical information report (TIR) provides guidance to augment information and requirements for parametric release provided in ANSI/AAMI/ISO 11135:1994, Medical devices? Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intended to assist those individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary to develop and validate an ethylene oxide sterilization process that meets the standard?s requirements for parametric release. This TIR also provides guidance for choosing the appropriate actions where alternatives are given. The guidance in this TIR is limited to the sections of the standard that specifically address parametric release.