ISO/TS 21387:2020 医疗器械的灭菌 使用参数释放法的环氧乙烷灭菌过程的验证和常规处理要求指南

标准编号：ISO/TS 21387:2020

中文名称：医疗器械的灭菌 使用参数释放法的环氧乙烷灭菌过程的验证和常规处理要求指南

英文名称：Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

发布日期：2020-09

标准范围

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。注:为便于参考，本文件中的条款编号与ISO 11135标准部分中的编号一致。对于经验证的灭菌周期充分性声明中要求暴露于该过程中的生物指示剂（BIs）不增长的过程，没有提供额外的指导。

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.NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135.No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.

标准预览图