BS EN 868-6-1999 准备消毒的医疗设备用的包装材料和系统.经氧化乙烯或辐照杀菌的生产医用包裹的纸.要求和试验方法

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【英文标准名称】:Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Paperforthemanufactureofpacksformedicaluseforsterilizationbyethyleneoxideorirradiation-Requirementsandtestmethods
【原文标准名称】:准备消毒的医疗设备用的包装材料和系统.经氧化乙烯或辐照杀菌的生产医用包裹的纸.要求和试验方法
【标准号】:BSEN868-6-1999
【标准状态】:作废
【国别】:英国
【发布日期】:1999-11-15
【实施或试行日期】:1999-11-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:灭菌;包装;盖;作标记;医疗设备;防水材料;材料强度;有毒物质;尺寸;纯度;浸出;包装材料;荧光;试样;方程;性能;尺寸公差;试验设备;试样制备;包装件;抗拉强度;防水试验;成份允差;化学成分;捆扎;医疗器械;氧化乙烯;孔隙度测量;辐射;纸;无菌设备;外观检查(试验);环氧乙烷
【英文主题词】:Applications;Blasting;Definitions;Ethyleneoxide;Hygiene;Inspection;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartoftheseriesofEN868providesexamplesofparticularrequirementsandtestmethodsforpaperusedinthemanufactureofpacksformedicaluse.ItintroducesnoadditionalrequirementstothegeneralrequirementsofPart1butprovidesguidancebaseduponvariouselementsofformer,relevantnationalstandards.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofPart1.ThepaperspecifiedinthispartoftheseriesEN868issuitableforthemanufactureofpackagestobeusedinethyleneoxideorirradiationsterilizationprocesses.PaperspecifiedinthispartoftheseriesEN868isintendedforuseinpartorcompletemanufactureofpouchesandformandfillpacksandliddingmaterialforpacks.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:10P;A4
【正文语种】:英语