【英文标准名称】:Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Re-usablesterilizationcontainersforsteamsterilizersconformingtoEN285: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.符合EN285规定的蒸汽消毒器用的可重复使用的消毒容器.要求和试验方法
【标准号】:BSEN868-8-1999
【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】:试验条件;寿命;重复使用包装件;灭菌;包装;荷载能力;性能试验;盖;材料强度;加速度试验;尺寸;消费者与供货者的关系;生产;孔;老化试验;包装材料;重量测量;试样;尺寸公差;医疗设备;疏松材料;作标记;包装件;容器;机械试验;试验设备;设计;捆扎;医疗器械;蒸汽;手柄;闭塞物;使用说明;性能;无菌设备;外观检查(试验);堆积试验
【英文主题词】:Applications;Containers;Hygiene;Inspection;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Products;Re-usable;Safety;Safetyrequirements;Specification(approval);Steamsterilization;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartoftheseriesofEN868providesexamplesofparticularrequirementsandtestmethodsforre-usablecontainersforsteamsterilization.ItintroducesnoadditionalrequirementstothegeneralrequirementsofPart1butprovidesguidancebaseduponvariouselementsofformer,relevantnationalstandards.Assuch,theparticularrequirementsin4.2to4.7canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofPart1.ThecontainersspecifiedinthispartofthestandardareintendedtobeusedasapackagingsystemduringthesterilizationofmedicaldevicesinsteamsterilizersconformingtoEN285andthesubsequenttransportationandstorageofthosedevices.NOTE1WhenitisintendedtousethecontainersinasteamsterilizernotconformingtoEN285thesterilizationperformanceofthecontainerinthespecificsterilizationcycletobeusedisvalidatedbytheuser.Otherattributesofthecontainerarealsoreviewedforcompatibilitywiththesterilizercyclee.g.operatingtemperature.NOTE2Whengoodsarerequiredtobemultiplewrappedinordertofulfilthegeneralrequirements,theyshouldfirstbepackagedinasterilizationpackagingmaterial(e.g.amaterialasspecifiedinotherpartsofthisseriesofstandards).
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:12P.;A4
【正文语种】:英语