標準號：DIN EN 868-5-2009
中文標準名稱：*終滅菌醫療器械的包裝.第5部分:多孔材料和塑料薄膜結構的可密封袋和卷軸.試驗方法和要求.英文版本DIN EN 868-5-2009-09
英文標準名稱：Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods;English version of DIN EN 868-5:2009-09
標準類型：C08
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C08
國際標準分類號：11.080.30
引用標準：EN 868-2;EN 868-3;EN 868-6;EN 868-7;EN 868-9;EN 868-10;EN ISO 11140-1;EN ISO 11607-1-2006;ISO 8601;ASTM D882-1995
適用范圍：This part of EN 868 provides test methods and values for sealable pouches and reels manufactured fromporous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminallysterilized 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 theproducts covered by this part of EN 868 but does not add or modify the general requirements specified inEN ISO 11607-1.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or morebut not all of the requirements of EN ISO 11607-1.The materials specified in this part of EN 868 are intended for single use only.NOTE 2 When additional materials are used inside the sterile barder system in order to ease the organization, dryingor aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, trayliners or an additional envelope around the medical device) then other requirements, including the determination of theacceptability of these materials during validation activities, may apply.