ASTM F2580-2009 最接近固定股骨髋假体标准接头的评估用标准试验方法
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【英文标准名称】:StandardTestMethodforEvaluationofModularConnectionofProximallyFixedFemoralHipProsthesis
【原文标准名称】:最接近固定股骨髋假体标准接头的评估用标准试验方法
【标准号】:ASTMF2580-2009
【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】:F04.22
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:arthroplasty;femoralhipprostheses;orthopedicmedicaldevices;proximalfixation;totalhiparthroplasty;Arthroplasty;Femoralsurgicalcomponents;Hipreplacementprosthesis;Prostheses
【摘要】:Thistestmethodcanbeusedtodescribetheeffectsofmaterials,manufacturing,anddesignvariablesonthefatigueperformanceofmetallicfemoralhipprosthesessubjecttocyclicloadingforlargenumbersofcycles.Theloadingoffemoralhipdesignsinvivowill,ingeneral,differfromtheloadingdefinedinthistestmethod.Theresultsobtainedherecannotbeusedtodirectlypredictinvivoperformance.However,thistestmethodisdesignedtoallowforcomparisonsbetweenthefatigueperformanceofdifferentmetallicfemoralhipdesigns,whentestedundersimilarconditions.Inorderforfatiguedataonfemoralhipprosthesestobecomparable,reproducible,andcapableofbeingcorrelatedamonglaboratories,itisessentialthatuniformproceduresbeestablished.1.1Thistestmethodcoversaprocedureforthefatiguetestingofmetallicfemoralhipprosthesesusedinhipjointreplacements.Thistestmethodcoverstheproceduresfortheperformanceoffatiguetestsonmetallicfemoralhipstemsusingacyclic,constant-amplitudeforce.Itappliestohipprosthesesthatutilizeproximalmetaphysealfixationandareofamodularconstruct,anditisintendedtoevaluatethefatigueperformanceofthemodularconnectionsinthemetaphysealfilling(thatis,proximalbody)regionofthestem.1.2Thistestmethodisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallichipprostheseswhileheldinaproximallyfixatedmanner,withthedistalendnotheldbyapottingmedium.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalandchemicalindicators-Testequipment
【原文标准名称】:保健产品的消毒.生物和化学指示剂.试验器械
【标准号】:ISO18472-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-06
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:生物指示剂;特性;检验设备;化学指示剂;定义;文献工作;特点;医疗卫生事业;指示器;医学科学;性能要求;记录;规范(验收);灭菌;杀菌器具;试验设备;试验;试验装置
【英文主题词】:Biochemicals;Bio-indicators;Biologicalhazards;Biologicalsystems;Characteristics;Checkingequipment;Chemicalindicators;Definitions;Documentations;Efficiency;Ethyleneoxide;Features;Germs;Healthservices;Heat;Hotairsterilizers;Indicators;Inoculation;Markingofroads;Medicalequipment;Medicalsciences;Methods;Microbiologicalanalysis;Microorganisms;Operation;Packages;Performancerequirements;Population;Qualifications;Ratingtests;Recording;Recordingequipment;Recordingsystems;Resistance;Sequenceofoperations;Specification(approval);Steamsterilizers;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Sterilizinggases;Surveillance(approval);Survivalcharacteristics;Systems;Testequipment;Testgerms;Testing;Testingdevices;Use;Validation;Vapours
【摘要】:1.1ThisInternationalStandardspecifiestherequirementsfortestequipmenttobeusedtotestchemicalandbiologicalindicatorsforsteam,ethyleneoxide,dryheatandvaporizedhydrogenperoxideprocessesforconformitytotherequirementsgiveninISO11140-1forchemicalindicators,ortherequirementsgivenintheISO11138seriesforbiologicalindicators.ThisInternationalStandardalsoprovidesinformativemethodsusefulincharacterizingtheperformanceofbiologicalandchemicalindicatorsforintendeduseandforroutinequalitycontroltesting.ISO11138-2,ISO11138-3,ISO11138-4,andISO11140-1requiretheuseofresistometersspecifiedinthisInternationalStandard,andtheseresistometersareusedinconjunctionwiththetestmethodsspecifiedintheappropriatepartsofISO11138andISO11140.NOTEResistometersforformaldehydeindicatorsarenotincludedinthisInternationalStandard.Testmethodsusinglaboratoryapparatusforsteam-formaldehydeareincludedinISO11138-5,ISO11140-3andISO11140-4.1.2ThisInternationalStandarddoesnotaddressthemethodsusedtodemonstratecomplianceofbiologicalorchemicalindicatorstoISO11138andISO11140,asthesearecoveredintheappropriatepartsofthesestandards.Indicatorsusedwithcombinationprocesses,suchaswasher-disinfection,arenotcoveredbythisInternationalStandard.NOTETestequipmentandmethodsnecessaryforISO11140-3,ISO11140-4orISO11140-5arespecifiedinthosestandards.1.3ThisInternationalStandarddoesnotaddresssafetyaspectsofthetestequipmentbecausetheseareusuallycoveredbyspecificregional,nationalorlocalregulations.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:28P;A4
【正文语种】:英语
【英文标准名称】:Ferrulesandassemblywiresforbraidedrubbercordassembliesforaerospaceuse
【原文标准名称】:航空航天用的编织橡胶绳组件的外用套管和组合金属丝
【标准号】:BS3SP168-169-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-09-27
【实施或试行日期】:2002-09-27
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:金属线;钢;尺寸;飞行器部件;编织绳;软索;橡胶;箍
【英文主题词】:Aircraftcomponents;Braidedcords;Cords;Dimensions;Ferrules;Rubber;Steels;Wires
【摘要】:ThisBritishStandardspecifiesthematerials,dimensionsandfinishforsteelwireferrules(BS3SP168)andassociatedassemblywires(BS3SP169)forusewithbraidedrubbercordsconformingtoBSF70andBSF71andforfinishedassembliesspecifiedinBSSP170-171,foraerospaceapplications.
【中国标准分类号】:V11
【国际标准分类号】:49_035
【页数】:8P.;A4
【正文语种】:英语