DIN EN 868-8-2009 最终灭菌医疗器械的包装.第8部分:符合EN285标准的蒸气消毒器的可重复使用的消毒罐.试验方法和要求.英文版本DINEN868-8-2009-09
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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part8:Re-usablesterilizationcontainersforsteamsterilizersconformingtoEN285-Requirementsandtestmethods;EnglishversionofDINEN868-8:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第8部分:符合EN285标准的蒸气消毒器的可重复使用的消毒罐.试验方法和要求.英文版本DINEN868-8-2009-09
【标准号】:DINEN868-8-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用;容器;卫生学;检验;作标记;材料;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;包装件;包装;包装材料;包装试验;产品;可重复使用;安全性;安全性要求;规范(验收);蒸汽灭菌;绝育;灭菌;消毒物品;灭菌器;储存;测试;运输包装;证实
【英文主题词】:Applications;Containers;Hygiene;Inspection;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packaging;Packagingmaterial;Packagingtests;Products;Re-usable;Safety;Safetyrequirements;Specification(approval);Steamsterilization;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforre-usablecontainersusedassterilebarriersystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.ThesecontainersareintendedtobeusedinsteamsterilizersconformingtoEN285.NOTE1Theneedforapackagingmaterialinsidethecontainerisdeterminedbythemanufacturesandusers.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddnormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.NOTE2WhenitisintendedtousethecontainersinasteamsterilizernotconformingtoEN285thesterilizationper-formanceofthecontainerinthespecificsterilizationcycletobeusedisvalidatedbytheuser.Otherattributesofthecontainerarealsoreviewedforcompatibilitywiththesterilizercyclee.g.operatingtemperature.NOTE3Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilter,indicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:21P.;A4
【正文语种】:英语
【原文标准名称】:最终灭菌医疗器械的包装.第8部分:符合EN285标准的蒸气消毒器的可重复使用的消毒罐.试验方法和要求.英文版本DINEN868-8-2009-09
【标准号】:DINEN868-8-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用;容器;卫生学;检验;作标记;材料;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;包装件;包装;包装材料;包装试验;产品;可重复使用;安全性;安全性要求;规范(验收);蒸汽灭菌;绝育;灭菌;消毒物品;灭菌器;储存;测试;运输包装;证实
【英文主题词】:Applications;Containers;Hygiene;Inspection;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packaging;Packagingmaterial;Packagingtests;Products;Re-usable;Safety;Safetyrequirements;Specification(approval);Steamsterilization;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforre-usablecontainersusedassterilebarriersystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.ThesecontainersareintendedtobeusedinsteamsterilizersconformingtoEN285.NOTE1Theneedforapackagingmaterialinsidethecontainerisdeterminedbythemanufacturesandusers.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddnormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.NOTE2WhenitisintendedtousethecontainersinasteamsterilizernotconformingtoEN285thesterilizationper-formanceofthecontainerinthespecificsterilizationcycletobeusedisvalidatedbytheuser.Otherattributesofthecontainerarealsoreviewedforcompatibilitywiththesterilizercyclee.g.operatingtemperature.NOTE3Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilter,indicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:21P.;A4
【正文语种】:英语
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