标准编号：ISO 11607-1:2019
中文名称：定期长效消毒的医疗设备的包装 第1部分：材料、无菌隔层系统和包装系统的要求
英文名称：Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
发布日期：2019-02
标准范围
This document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile
barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal.
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