DIN EN 868-4:2009
最终灭菌医疗器械的包装.第4部分:纸袋.试验方法和要求.英文版本DIN EN 868-4-2009-09

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; English version of DIN EN 868-4:2009-09

被代替

标准号

DIN EN 868-4:2009

发布

2009年

发布单位

德国标准化学会

替代标准

DIN EN 868-4:2017

DIN EN 868-4 E:2015-08

当前最新

DIN EN 868-4:2017-05

 

 

引用标准

EN 868-3 EN ISO 11140-1 EN ISO 11607-1:2006 EN ISO 1924-2 ISO 6588-2:2005 ISO 8601 ISO 9197 ISO 9198

被代替标准

DIN EN 868-4:1999 DIN EN 868-4:2007

适用范围

This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of EN 868, 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. 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 or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.6 can be used to demonstrate compliance with one or more but 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 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.

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