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.