【英文标准名称】:Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Adhesivecoatednonwovenmaterialsofpolyolefinesforuseinthemanufactureofheatsealablepouches,reelsandlids-Requirementsandtestmethods
【原文标准名称】:准备消毒的医疗装置用的包装材料和系统.用于生产热密封袋,卷轴和合盖的粘接剂包覆的非纺织的聚烯烃材料.要求和试验方法
【标准号】:BSEN868-10-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-07-15
【实施或试行日期】:2000-07-15
【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】:聚烯烃纤维;胶粘剂;热密封材料;层覆材料;卷筒(物料装卸设备);聚烯烃;包装材料;医疗设备;无菌设备;医疗器械;盖;灭菌;覆层;包装
【英文主题词】:Adhesive;Adhesivefilm;Adhesives;Applications;Bagfoil;Bags;Coated;Flexiblepipes;Flexibleplasticstubepackaging;Heat-sealingmaterials;Hygiene;Inspection;Laminatedfoils;Lids;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Non-wovenfabrics;Packages;Packagescontainers;Packagingmaterial;Packagingtests;Plastics;Polyolefins;Production;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transparentsterilizingpacking;Transportpacking;Validation
【摘要】:ThispartofEN868providesexamplesofparticularrequirementsforadhesivecoatednonwovenmaterialsofpolyolefinessuitableforuseaspackagingofmedicaldeviceswhicharetobeterminallysterilized.Itintroducesnoadditionalrequirementstothegeneralrequirementsofpart1.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofpart1.ThematerialspecifiedinthispartoftheseriesEN868isintendedforuseinpartorcompletemanufactureofheatsealablepouches,formandfillpacksandliddingmaterialsforpacks.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:16P;A4
【正文语种】:英语