ISO 11607-1:2006 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

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

ISO 11607-1:2006规定了材料、预制无菌屏障系统、无菌屏障系统和包装系统的要求和试验方法，这些系统旨在在使用前保持最终灭菌医疗器械的无菌性。ISO 11607-1:2006适用于工业、医疗保健设施，以及医疗设备放置在无菌屏障系统中并经过消毒的任何地方。ISO 11607-1:2006未涵盖无菌生产医疗器械的无菌屏障系统和包装系统的所有要求。药物/设备组合可能还需要额外的要求。ISO 11607-1:2006没有描述控制所有制造阶段的质量保证体系。

ISO 11607-1:2006 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.ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.ISO 11607-1:2006 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 for drug/device combinations.ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

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