本欧洲标准草案提供了用于制造预先形成的无菌屏障系统和/或包装系统的纸张的测试方法和价值，这些系统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至4.3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。 EN 868系列本部分规定的纸张用于部分或完整的袋子和包装填充包装和盖子材料的制造。 注1:EN 868系列本部分规定的纸张适用于制造用于环氧乙烷，辐射或低温蒸汽甲醛灭菌工艺的无菌屏障系统，并根据EN 868-7生产涂层纸。 注2:根据EN 868-3的纸张也可用于这些灭菌过程。 本部分规定的材料

This draft European Standard provides test methods and values for paper used in the manufacture of preformed 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 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. 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 filters, 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.