【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part5:Sealablepouchesandreelsofporousmaterialsandplasticfilmconstruction-Requirementsandtestmethods;EnglishversionofDINEN868-5:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第5部分:多孔材料和塑料薄膜结构的可密封袋和卷轴.试验方法和要求.英文版本DINEN868-5-2009-09
【标准号】:DINEN868-5-2009
【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;袋;定义(术语);尺寸规格;柔性管;可弯曲塑料管包装;货物;热封;热密封材料;卫生学;检验;叠层箔;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;塑料;产品;安全性;安全性要求;操作程序;规范(验收);绝育;灭菌;消毒纸;消毒物品;灭菌器;储存;试验;公差(测量);透明包装;透明灭菌包装;运输包装;使用;证实
【英文主题词】:Applications;Bags;Definitions;Dimensions;Flexiblepipes;Flexibleplasticstubepackaging;Goods;Heat-sealing;Heat-sealingmaterials;Hygiene;Inspection;Laminatedfoils;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Paperbags;Plastics;Products;Safety;Safetyrequirements;Sequenceofoperations;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizationpapers;Sterilizedgoods;Sterilizers;Storage;Testing;Tolerances(measurement);Transparentpackages;Transparentsterilizingpacking;Transportpacking;Use;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforsealablepouchesandreelsmanufacturedfromporousmaterialscomplyingwitheitherEN868part2,3,6,7,9or10andplasticfilmcomplyingwithClause4usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE2Whenadditionalmaterialsareusedinsidethesterilebardersysteminordertoeasetheorganization,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】:22P.;A4
【正文语种】:英语