ISO 11607-2:2006 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 11607-2:2006

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：2006-04

标准范围

ISO 11607-2:2006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。ISO 11607-2:2006适用于工业、医疗保健设施以及医疗器械包装和消毒的任何地方。ISO 11607-2:2006未涵盖无菌生产的医疗器械包装的所有要求。对于药物/器械组合，可能还需要额外的要求。

ISO 11607-2:2006 specifies the requirements for 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.ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

标准预览图