ISO 11607-2:2019 定期长效消毒的医疗设备的包装 第2部分：组成,密封和封装程序的确认要求

标准编号：ISO 11607-2:2019

中文名称：定期长效消毒的医疗设备的包装 第2部分：组成,密封和封装程序的确认要求

英文名称：Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

发布日期：2019-02

标准范围

本文件规定了最终灭菌医疗器械包装工艺的开发和验证要求。这些过程包括预制无菌屏障系统、无菌屏障系统和包装系统的成型、密封和组装。它适用于工业、医疗保健设施，以及任何包装和消毒医疗器械的地方。它不包括无菌生产的医疗设备包装的所有要求。药物/设备组合可能需要额外的要求。

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

标准预览图