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
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.
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