【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part6:Paperforlowtemperaturesterilizationprocesses-Requirementsandtestmethods;EnglishversionofDINEN868-6:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第6部分:低温灭菌处理用纸.试验方法和要求.英文版本DINEN868-6-2009-09
【标准号】:DINEN868-6-2009
【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】:可处置的;一次性使用设备;环氧乙烷;卫生学;检验;低温;作标记;医疗器械;医疗器材;医学科学;医疗技术学;包装件;包装材料;包装试验;纸;孔径;产品;安全性;安全性要求;规范(验收);绝育;辐射灭菌;灭菌;消毒物品;灭菌器;试验;运输包装;证实;拒水性
【英文主题词】:Disposable;Equipmentforsingleuse;Ethyleneoxide;Hygiene;Inspection;Lowtemperatures;Marking;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Poresizes;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilizationbyirradiation;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Testing;Transportpacking;Validation;Waterrepellency
【摘要】:ThispartofEN868providestestmethodsandvaluesforpaperusedinthemanufactureofpreformedsterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.3canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.PaperspecifiedinthispartoftheseriesEN868isintendedforuseinpartorcompletemanufactureofpouchesandformandfillpacksandliddingmaterialforpacks.NOTE2ThepaperspecifiedinthispartoftheseriesEN868issuitableforthemanufactureofsterilebarriersystemstobeusedinethyleneoxide,irradiationorlowtemperaturesteamformaldehydesterilizationprocessesandtoproducecoatedpaperaccordingtoEN868-7.NOTE3PaperaccordingtoEN868-3canalsobeusedforthesesterilizationprocesses.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE4Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilters,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】:20P.;A4
【正文语种】:英语