DIN EN 868-8-2009 最终灭菌医疗器械的包装.第8部分:符合EN 285标准的蒸气消毒器的可重复使用的消毒罐.试验方法和要求.英文版本DIN EN 868-8-2009-09

标准号：DIN EN 868-8-2009
中文标准名称：*终灭菌医疗器械的包装.第8部分:符合EN 285标准的蒸气消毒器的可重复使用的消毒罐.试验方法和要求.英文版本DIN EN 868-8-2009-09
英文标准名称：Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; English version of DIN EN 868-8:2009-09
标准类型：C08
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C08
国际标准分类号：11.080.30
引用标准：EN 285-2006;EN 10088-1;EN ISO 4017;EN ISO 11607-1-2006;ISO 4582
适用范围：This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systemsthat are intended to maintain sterility of terminally sterilized medical devices to the point of use. Thesecontainers 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 manufactures and users.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 nor 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.NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization per-formance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of thecontainer are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature.NOTE 3 When additional materials are used inside the sterile barrier 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.