【英文标准名称】:Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Sterilizationwrap-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.消毒包裹物.要求和试验方法
【标准号】:BSEN868-2-1999
【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】:抗扯裂强度;包装;灭菌;材料的光学性质;试验条件;悬垂性测定;孔隙率;pH值;包装纸;透气率;作标记;性能;尺寸;数学计算;断裂伸长;试验设备;包装材料;电阻率;试样制备;重量;医疗设备;纸;尺寸公差;防水试验;抗拉强度;无菌设备;孔隙度测量;医疗器械;皱纹纸
【英文主题词】:Applications;Definitions;Goods;Hygiene;Inspection;Marking;Medicalequipment;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartoftheseriesofEN868providesexamplesofparticularrequirementsandtestmethodsforsterilizationwrapsuitableforuseaspackagingofmedicaldeviceswhicharetobeterminallysterilized.ItintroducesnoadditionalrequirementstothegeneralrequirementsofPart1butprovidesguidancebaseduponvariouselementsofformer,relevantnationalstandards.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofPart1.NOTEIftheintendeduseasspecifiedbythemanufacturerincludesthepossibilityofthematerialbeingusedforotherapplications(e.g.sterilefield,containerfilterorasaninnerwrapforcontainers),thenadditionaland/orotherrequirementscanapply.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:14P.;A4
【正文语种】:英语