EN 60127-2-2003 微型熔断器.第2部分:管式熔断体
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来源:标准资料网
【英文标准名称】:Miniaturefuses-Part2:Cartridgefuselinks(IEC60127-2:2003+A1:2003);GermanversionEN60127-2:2003+A1:2003
【原文标准名称】:微型熔断器.第2部分:管式熔断体
【标准号】:EN60127-2-2003
【标准状态】:现行
【国别】:
【发布日期】:2004-04
【实施或试行日期】:2004-04-01
【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】:试验;规范(验收);室内;超小型熔断体;检验;熔断体;电气保护设备;设计;管式熔断体;尺寸选定;电气试验;尺寸;微型装配工艺;作标记;熔断器;G熔断器;G熔断体;微型熔断器;小型熔断器;基础设计数据;额定值;规范;电气工程
【英文主题词】:Basicdesigndata;Cartridgefuse-links;Design;Dimensioning;Dimensions;Electricalengineering;Electricalprotectionequipment;Electricaltesting;Fuse-links;Fuses;G-fuse-links;G-fuses;Incription;Indoors;Inspection;Marking;Microassembling;Microfuses;Miniaturefuses;Ratings;Specification;Specification(approval);Sub-miniaturefuse-links;Testing
【摘要】:
【中国标准分类号】:K31
【国际标准分类号】:29_120_50
【页数】:38P.;A4
【正文语种】:英语
【英文标准名称】:FormattingandUseofMaterialandChemicalPropertyDataandDatabaseQualityIndicators
【原文标准名称】:材料及化学制品性能数据和数据库质量指示器的格式和使用
【标准号】:ASTME1484-1992
【标准状态】:作废
【国别】:美国
【发布日期】:1992
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:数据基础;材料;材料
【英文主题词】:databasis;materials;materials
【摘要】:
【中国标准分类号】:G07
【国际标准分类号】:35_240_50
【页数】:3P;A4
【正文语种】:英语
【英文标准名称】:StandardGuideforPre-clinicalinvivoEvaluationinCriticalSizeSegmentalBoneDefects
【原文标准名称】:节段性骨缺损临界粒度的活体潜伏期评定的标准指南
【标准号】:ASTMF2721-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.44
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:animalmodels;biomaterials;bone;boneregeneration;bonerepair;defectgeneration;devices;implants;invivo;mechanicaltesting;syntheticbiomaterials;TEMPs(TissueEngineeredMedicalProducts);Animalexperimentation;
【摘要】:Thisguideisaimedatprovidingarangeofinvivomodelstoaidinpreclinicalresearchanddevelopmentoftissue-engineeredmedicalproducts(TEMPs)intendedfortheclinicalrepairorregenerationofbone.Thisguideincludesadescriptionoftheanimalmodels,surgicalconsiderations,andtissueprocessingaswellasthequalitativeandquantitativeanalysisoftissuespecimens.TheuserisencouragedtouseappropriateASTMandotherguidelinestoconductcytotoxicityandbiocompatibilitytestsonmaterials,TEMPs,orboth,priortoassessmentoftheinvivomodelsdescribedherein.ItisrecommendedthatsafetytestingbeinaccordancewiththeprovisionsoftheFDAGoodLaboratoryPracticesRegulations21CFR58.Safetyandeffectivenessstudiestosupportregulatorysubmissions(forexample,InvestigationalDeviceExemption(IDE)),PremarketApproval(PMA),510K,InvestigationalNewDrug(IND),orBiologicsLicenseApplication(BLA)submissionsintheU.S.)shouldconformtoappropriateguidelinesoftheregulatorybodiesfordevelopmentofmedicaldevices,biologics,ordrugs,respectively.Animalmodeloutcomesarenotnecessarilypredictiveofhumanresultsandshould,therefore,beinterpretedcautiouslywithrespecttopotentialapplicabilitytohumanconditions.1.1Thisguidecoversgeneralguidelinesfortheinvivoassessmentoftissueengineeredmedicalproducts(TEMPs)intendedtorepairorregeneratebone.TEMPsincludedinthisguidemaybecomposedofnaturalorsyntheticbiomaterials(biocompatibleandbiodegradable)orcompositesthereof,andmaycontaincellsorbiologicallyactiveagentssuchasgrowthfactors,syntheticpeptides,plasmids,orcDNA.Themodelsdescribedinthisguidearesegmentalcriticalsizedefectswhich,bydefinition,willnotfillwithviabletissuewithouttreatment.Thus,thesemodelsrepresentastringenttestofamaterialx2019;sabilitytoinduceoraugmentbonegrowth.1.2Guidelinesincludeadescriptionandrationaleofvariousanimalmodelsincludingrat(murine),rabbit(leporine),dog(canine),goat(caprine),andsheep(ovine).Outcomemeasuresbasedonradiographic,histologic,andmechanicalanalysesaredescribedbrieflyandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetail.1.3Thisguideisnotintendedtoincludethetestingofrawmaterials,preparationofbiomaterials,sterilization,orpackagingoftheproduct.ASTMstandardsforthesestepsareavailableintheReferencedDocuments(Section2).1.4Theuseofanyofthemethodsincludedinthisguidemaynotproducearesultthatisconsistentwithclinicalperformanceinoneormorespecificapplications.1.5Otherpre-clinicalmethodsmayalsobeappropriateandthisguideisnotmeanttoexcludesuchmethods.Thematerialmustbesuitableforitsintendedpurpose.Additionalbiologicaltestinginthisregardwouldberequired.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_100_10
【页数】:13P.;A4
【正文语种】:英语
