ASTM F2458-2005(2010) 组织胶粘剂和封闭剂的伤口闭合强度的标准试验方法

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【英文标准名称】:StandardTestMethodforWoundClosureStrengthofTissueAdhesivesandSealants
【原文标准名称】:组织胶粘剂和封闭剂的伤口闭合强度的标准试验方法
【标准号】:ASTMF2458-2005(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2005
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:adhesivestrength;cohesivestrength;tissueadhesive;woundclosurestrength;Tissueadhesives
【摘要】:Materialsanddevicesthatfunctionatleastinpartbyadheringtolivingtissuesarefindingincreasinguseinsurgicalprocedureseitherasadjunctstosuturesandstaples,orasfrankreplacementsforthosedevicesinawidevarietyofmedicalprocedures.Whilethenatureandmagnitudeoftheforcesinvolvedvariesgreatlywithindicationandwithpatientspecificcircumstances,allusesinvolvetosomeextenttheabilityofthematerialtoresistimposedmechanicalforces.Therefore,themechanicalpropertiesofthematerials,andinparticulartheadhesiveproperties,areimportantparametersinevaluatingtheirfitnessforuse.Inaddition,themechanicalpropertiesofagivenadhesivecompositioncanprovideausefulmeansofdeterminingproductconsistencyforqualitycontrolorasameansfordeterminingtheeffectsofvarioussurfacetreatmentsonthesubstratepriortouseofthedevice.Thecomplexityandvarietyofindividualapplicationsfortissueadhesivedevices,evenwithinasingleindicateduse(surgicalprocedure,whichitselfmayvarydependingonphysicalsiteandclinicalintention)issuchthattheresultsofasingletensilestrengthtestisnotsuitablefordeterminingallowabledesignstresseswithoutthoroughanalysisandunderstandingoftheapplication,adhesivebehaviors,andclinicalindications.Thistestmethodmaybeusedforcomparingadhesivesorbondingprocessesforsusceptibilitytofatigue,modeoffailure,andenvironmentalchanges,butsuchcomparisonsmustbemadewithgreatcautionsincedifferentadhesivesmayresponddifferentlytovaryingconditions.Acorrelationofthetestmethodresultswithactualadhesiveperformanceinlivehumantissuehasnotbeenestablished.1.1Thistestmethodcoversameansforcomparisonofwoundclosurestrengthoftissueadhesivesusedtohelpsecuretheappositionofsofttissue.Withtheappropriatechoiceofsubstrate,itmayalsobeusedforpurposesofqualitycontrolinthemanufactureofmedicaldevicesusedastissueadhesives.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_120_20
【页数】:5P.;A4
【正文语种】:英语