EN 868的这一部分提供了用作无菌屏障系统的可重复使用的容器的测试方法和值，旨在将终末消毒的医疗设备的无菌性保持在使用点。这些容器旨在用于符合EN 285的蒸汽灭菌器。 注1:容器内的包装材料的需要由制造商和用户决定。 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4.5中的特定要求可用于证明符合EN ISO 11607-1中的一项或多项但不是全部要求。 注2:如果要使用不符合EN 285标准的蒸汽灭菌器中的容器，则使用特定灭菌周期的容器的灭菌性能由使用者验证。还审查了容器的其他特性以与灭菌器循环的相容性，例如工作温度 注3当在无菌屏障系统内使用其他材料以便于组织，干燥或无菌显示时（例如内包装，容器滤纸

This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document. NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating temperature. NOTE 3 The use of additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) is not covered in this part of EN 868. However, other requirements, including the determination of the acceptability of these materials and/or accessories during validation activities, can apply.