最终灭菌医疗器械的包装.聚烯烃粘性涂覆非织物材料.试验方法和要求

标准编号：BS EN 868-10-2009

提出单位：BSI

起草单位：BSI

发布日期：2009年

实施日期：20091031

主      题：粘着性的 胶膜 胶粘剂 应用 箔袋 袋 涂覆的 可处置的 一次性使用设备 柔性管 可弯曲塑料管包装 热密封材料 卫生学 检验 叠层箔 盖 作标记 医疗器械 医疗设备 医疗产品 医学科学 医疗技术学 无纺织织物 包装件 包装容器 包装材料 包装试验 塑料 聚烯烃 生产 产品 安全性 安全性要求 规范(验收) 消杀 灭菌 消毒物品 灭菌器 储存 测试 透明无菌包装 运输包装 证实 

中国标准分类号：C08

国际标准分类号：11_080_30

摘      要：polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 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 nor 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. NOTE 2 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.