本文件提供了ISO 11135要求的指南，当参数释放用于在暴露于灭菌过程后释放产品时适用。它为现有周期的转换提供了一条路径，也为新周期的参数化发布规范的开发和实施提供了一条路径。此外，它还强调了影响环氧乙烷（EO）灭菌过程再现性的其他工艺因素的重要性和相互关系，即负荷配置和设备性能。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.All current amendments available at time of purchase are included with the purchase of this document.