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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part4:Paperbags-Requirementsandtestmethods;EnglishversionofDINEN868-4:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第4部分:纸袋.试验方法和要求.英文版本DINEN868-4-2009-09
【标准号】:DINEN868-4-2009
【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;可处置的;一次性使用设备;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;pH值;产品;安全性;安全性要求;密封;规范(验收);灭菌材料供应;绝育;灭菌;消毒物品;灭菌器;储存;抗拉强度;测试;运输包装;证实
【英文主题词】:Applications;Bags;Disposable;Equipmentforsingleuse;Hygiene;Inspection;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Paperbags;pH;Products;Safety;Safetyrequirements;Sealing;Specification(approval);Sterilesupply;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Tensilestrength;Testing;Transportpacking;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforpaperbagsmanufacturedfrompaperspecifiedinPart3ofEN868,usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.6canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE2Whenadditionalmaterialsareusedinsidethesterilebarriersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilterindicators,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】:16P.;A4
【正文语种】:英语


【英文标准名称】:Continuoushandlingequipmentandsystems-SafetyandEMCrequirementsforequipmentformechanicalhandlingofunitloads;GermanversionEN619:2002+A1:2010
【原文标准名称】:连续搬运设备和系统.成组货件机械搬运设备安全和电磁兼容要求;德文版本EN619-2002+A1-2010
【标准号】:EN619-2010
【标准状态】:现行
【国别】:
【发布日期】:2011-02
【实施或试行日期】:2011-02-01
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Bodyregions;Castors;Commissioning;Contactsafetydevices;Continuousconveyors;Conveyers;Conveyorsystems;Conveyors;Dangerarea;Definitions;Drawing-in;Drop;Electriccontactprotection;Electricenergy;Electricalequipment;Electricalsafety;Electromagneticcompatibility;Electrostatic;Electrostatics;EMC;Ergonomics;Explosions;Hazards;Installations;Instruments;Liftingappliances;Liftingdevices;Marking;Mechanicalcrimping;Noise(environmental);Noisereduction;Operatinginstructions;Operationalsafety;Operators;Planning;Poisoning;Production;Protectivemeasures;Radiation;Rollers;Safetymeasures;Safetyrequirements;Shearing;Slip;Storageequipment;Storagesystem;Stumble;Systems;Unitloads;Vibration
【摘要】:
【中国标准分类号】:J81
【国际标准分类号】:53_040_10
【页数】:79P.;A4
【正文语种】:英语