DIN EN 868-3-2009 最终灭菌医疗器械的包装.第3部分:生产纸袋(EN868-4标准指定)和生产盒和卷筒(EN868-5标准指定)用纸.试验方法和要求.英文版本DINEN868-3-2009-09
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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part3:Paperforuseinthemanufactureofpaperbags(specifiedinEN868-4)andinthemanufactureofpouchesandreels(specifiedinEN868-5)-Requirementsandtestmethods;EnglishversionofDIN
【原文标准名称】:最终灭菌医疗器械的包装.第3部分:生产纸袋(EN868-4标准指定)和生产盒和卷筒(EN868-5标准指定)用纸.试验方法和要求.英文版本DINEN868-3-2009-09
【标准号】:DINEN868-3-2009
【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】:袋;可处置的;一次性使用设备;柔性管;卫生学;检验;作标记;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;纸;纸袋;产品;安全性;安全性要求;规范(验收);绝育;灭菌;消毒物品;灭菌器;试验;透明包装;透明灭菌包装;运输包装;证实
【英文主题词】:Bags;Disposable;Equipmentforsingleuse;Flexiblepipes;Hygiene;Inspection;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Paperbags;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Testing;Transparentpackages;Transparentsterilizingpacking;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforpaper,usedinthemanufactureofpaperbags(specifiedinEN868-4)andinthemanufactureofpouchesandreels(specifiedinEN868-5)usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.NOTE2Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilterindicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE3Applicablesterilizationmethodsarespecifiedbythemanufacturer.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:16P.;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3部分:生产纸袋(EN868-4标准指定)和生产盒和卷筒(EN868-5标准指定)用纸.试验方法和要求.英文版本DINEN868-3-2009-09
【标准号】:DINEN868-3-2009
【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】:袋;可处置的;一次性使用设备;柔性管;卫生学;检验;作标记;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;纸;纸袋;产品;安全性;安全性要求;规范(验收);绝育;灭菌;消毒物品;灭菌器;试验;透明包装;透明灭菌包装;运输包装;证实
【英文主题词】:Bags;Disposable;Equipmentforsingleuse;Flexiblepipes;Hygiene;Inspection;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Paperbags;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Testing;Transparentpackages;Transparentsterilizingpacking;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforpaper,usedinthemanufactureofpaperbags(specifiedinEN868-4)andinthemanufactureofpouchesandreels(specifiedinEN868-5)usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.NOTE2Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilterindicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE3Applicablesterilizationmethodsarespecifiedbythemanufacturer.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:16P.;A4
【正文语种】:英语
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