标准编号：ISO 11607-1:2006
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：2006-04
标准范围
This part of ISO 11607 specifies the 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.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary fordrug/device combinations.This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.
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