本欧洲标准草案提供了纸张的测试方法和价值，用于制造纸袋（EN 868-4规定）和制造用作无菌屏障系统的袋和卷轴（EN868-5规定）或旨在将终末消毒的医疗装置的无菌性保持在使用点的包装系统。 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（例如内包装，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）时，那么其他要求，包括在验证活动期间确定这些材料的可接受性可能适用。 EN 868本部分规定的材料

This draft European Standard provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as 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 this part of EN 868 are intended for single use only. NOTE Applicable sterilization methods are specified by the manufacturer.