【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part7:Adhesivecoatedpaperforlowtemperaturesterilizationprocesses-Requirementsandtestmethods;EnglishversionofDINEN868-7:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第7部分:低温消毒处理的粘合铜版纸.试验方法和要求.英文版本DINEN868-7-2009-09
【标准号】:DINEN868-7-2009
【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】:胶粘纸;胶粘连接;胶粘剂;应用;涂层纸;可处置的;一次性使用设备;环氧乙烷;热密封材料;卫生学;检验;低温;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;包装材料;包装试验;纸;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;储存;测试;运输包装;证实
【英文主题词】:Adhesivepaper;Adhesive-bondedjoints;Adhesives;Applications;Coatedpaper;Disposable;Equipmentforsingleuse;Ethyleneoxide;Heat-sealingmaterials;Hygiene;Inspection;Lowtemperatures;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packaging;Packagingmaterial;Packagingtests;Paper;Products;Safety;Safetyrequirements;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Testing;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforsealableadhesivecoatedpapermanufacturedfrompapercomplyingwithEN868-6,usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.Thematerialsspecifiedinthispartareintendedtobeusedforethyleneoxideorirradiationsterilization.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.3canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.NOTE2Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilter,indicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:26P.;A4
【正文语种】:英语