标准摘要
[中文适用范围]： 本文件规定了旨在保持最终灭菌医疗器械在使用前保持无菌状态的材料、预制无菌屏障系统、无菌屏障系统和包装系统的要求和测试方法。 它适用于工业、医疗保健设施以及医疗器械放置在无菌屏障系统中并进行灭菌的任何地方。 它不涵盖无菌屏障系统和无菌制造的医疗器械包装系统的所有要求。 药物/器械组合可能需要额外的要求。 它没有描述用于控制制造的所有阶段的质量保证体系。 它不适用于在将物品运输到再处理或处置场所期间用于容纳受污染医疗器械的包装材料和/或系统。 [外文原描述]： 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.
英文名称Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems