BS EN 868-5:2018规定了由符合EN 868第2、3、6、7、9或10部分要求的多孔材料和符合第4条要求的塑料薄膜制成的可密封袋和卷盘的试验方法和数值。这些可密封袋和卷盘用作无菌屏障系统和/或包装系统，旨在将最终灭菌医疗设备的无菌性保持到使用点。交叉引用:EN 868-7:2017EN 868-2:2017ISO 11607-1:2006/AMD 1:2014EN 868-3:2017EN 868-9:2018ASTM D882-12ASTM F88/F88M- 15EN ISO 11140-1ISO 8601EN ISO 11607-1:2017ISO 11140-1EN 868-10:2018ISO 11607-1:2006EN 868-6:2017EN ISO 14937EN 1422EN ISO 11607-2EN 1041ISO 14937EN 14180EN 285ISO 11607-2EN 13060EN ISO 15223-1:2016ISO 15223-1:2016购买本文件时提供的所有现行修订版均包含在购买本文件中。

BS EN 868-5:2018 specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are 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.Cross References:EN 868-7:2017EN 868-2:2017ISO 11607-1:2006/AMD 1:2014EN 868-3:2017EN 868-9:2018ASTM D882 - 12ASTM F88/F88M - 15EN ISO 11140-1ISO 8601EN ISO 11607-1:2017ISO 11140-1EN 868-10:2018ISO 11607-1:2006EN 868-6:2017EN ISO 14937EN 1422EN ISO 11607-2EN 1041ISO 14937EN 14180EN 285ISO 11607-2EN 13060EN ISO 15223-1:2016ISO 15223-1:2016All current amendments available at time of purchase are included with the purchase of this document.