ASTM F2392-04R15 TEST METHOD FOR BURST STRENGTH OF SURGICAL SEALANTS英文版

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1、Designation:F2392−04(Reapproved2015)StandardTestMethodfor1BurstStrengthofSurgicalSealantsThisstandardisissuedunderthefixeddesignationF2392;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevisi

2、on.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope3.2.2burststrength—theaveragepressurerequiredtocausefailureofthesealant,eitherbycohesiveoradhesivemecha-1.1Thiste

3、stmethodprovidesameansforcomparisonofthenisms.burstorrupturestrengthofsealantsonsofttissue.Thistestmethodcanbeusedasaclinicallyrelevantmodelforquality3.2.3cohesivefailure—failureofthesealantduringburstassurance,development,andcomparativetestingofdifferentte

4、sting.adhesivesoradherends.3.2.4cohesivestrength—theinternalstrengthofthesealant,1.2Thistestmethodmeasuresonlyburststrengthor“co-sometimesreferredtoastheadhesivebulkstrength.hesivestrength”ofanadhesive/adherendsystem,andnotthe3.2.5substratefailure—failureof

5、thesubstrateduringburstadhesivestrength.testing.1.3ThevaluesstatedinSIunitsaretoberegardedas3.2.6tissuesealant—asurfacecoatingtopreventleakageofstandard.Nootherunitsofmeasurementareincludedinthisbodyfluids.standard.4.SignificanceandUse1.4Thisstandarddoesnotpu

6、rporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itisthe4.1Materialsanddevicesthatfunctionatleastinpartbyresponsibilityoftheuserofthisstandardtoestablishappro-adheringtolivingtissuesarefindingincreasinguseinsurgicalpriatesafetyandhealthpractic

7、esanddeterminetheapplica-procedures,eitherasadjunctstosuturesandstaplesorasfrankbilityofregulatorylimitationspriortouse.replacementsforthosedevicesinawidevarietyofmedicalprocedures.Whilethenatureandmagnitudeoftheforces2.ReferencedDocumentsinvolvedvariesgrea

8、tlywithindicationandwithpatientspecific2.1ASTMStandards:2circumstances,allusesinvolve,tosomeextent,theabilityofD907TerminologyofAdhesivesthematerialtoresistimposedmechanicalforces.Therefore,the2.2Americ