本欧洲标准草案为无菌屏障系统和/或包装系统的材料提供测试方法和价值观，旨在将终末消毒的医疗设备的无菌性保持在使用点。 保护性包装的需要可由制造商和用户确定。 EN 868的这一部分仅介绍了EN 868本部分涵盖的产品特有的性能要求和测试方法，但不添加或修改EN ISO 11607-1中规定的一般要求。 因此，4.2中的特定要求可用于证明符合EN ISO 11607-1中的一个或多个但不是全部要求。 当在无菌屏障系统内使用额外的材料以便于组织，干燥或无菌呈现（例如内包裹，容器过滤器，指示器，包装清单，垫子，仪器组织器组，托盘衬垫或医疗装置周围的附加信封），则可能会适用其他要求，包括在验证活动期间确定这些材料的可接受性。 EN 868本部分4.2.2.1至4.2.2.3中规定的材料是单次使用，4.2.2.4中规定的材料用于重新使用

This draft European Standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.