標(biāo)準(zhǔn)號(hào)：DIN EN 868-7-2009
中文標(biāo)準(zhǔn)名稱：*終滅菌醫(yī)療器械的包裝.第7部分:低溫消毒處理的粘合銅版紙.試驗(yàn)方法和要求.英文版本DIN EN 868-7-2009-09
英文標(biāo)準(zhǔn)名稱：Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; English version of DIN EN 868-7:2009-09
標(biāo)準(zhǔn)類型：C08
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C08
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.080.30
引用標(biāo)準(zhǔn)：EN 20187;EN 20535;EN 21974;EN ISO 536;EN ISO 1924-2;EN ISO 2758;EN ISO 11607-1-2006;ISO 3689;ISO 3781;ISO 5636-3;ISO 6588-2-2005;ISO 8601;ISO 9197;ISO 9198
適用范圍：This part of EN 868 provides test methods and values for sealable adhesive coated paper manufactured frompaper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intendedto maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in thispart are intended to be used for ethylene oxide or irradiation sterilization.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 4.3 can be used to demonstrate compliance with one or morebut 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, 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.The materials specified in this part of EN 868 are intended for single use only.