本文件规定了材料、预成型无菌屏障系统、无菌屏障系统和包装系统的要求和试验方法，这些系统旨在保持最终灭菌医疗器械的无菌性，直至使用。它适用于工业、卫生保健设施，以及医疗器械置于无菌屏障系统并进行消毒的任何地方。它不包括无菌制造的医疗器械的无菌屏障系统和包装系统的所有要求。药物\/设备组合可能需要附加要求。它没有描述控制所有制造阶段的质量保证体系。本规定不适用于在将受污染医疗器械运输至再加工或处置现场期间用于盛装受污染医疗器械的包装材料和\/或系统。

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.