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
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
立即下载标准文件