ASTM F1925-2009 外科植入物用半结晶(交酯)聚合物和共聚物树脂的标准规范

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【英文标准名称】:StandardSpecificationforSemi-CrystallinePoly(lactide)PolymerandCopolymerResinsforSurgicalImplants
【原文标准名称】:外科植入物用半结晶(交酯)聚合物和共聚物树脂的标准规范
【标准号】:ASTMF1925-2009
【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】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:PGA:PLA;PLA;PLA:PGA;PLGA;PlLA;polyglycolic:lacticacid;poly(glycolide:lactide);poly(lacticacid);polylactic:glycolicacid;polylactide;poly(lactide);poly(lactide:glycolide);poly(l-lact
【摘要】:1.1Thisspecificationcoversvirginsemi-crystallinepoly(l-lactide)orpoly(d-lactide)homopolymerresinsintendedforuseinsurgicalimplants.Thisspecificationalsocoverssemi-crystallineresinsofl-lactidecopolymerizedwithotherbioabsorbablemonomersincluding,butnotlimitedto,glycolide,d-lactide,anddl-lactide.Thepoly(l-lactide)orpoly(d-lactide)basedhomopolymersandcopolymerscoveredbythisspecificationpossesslactidesegmentsofsufficientlengthtoallowpotentialfortheircrystallizationuponannealing.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbreviatedasPLAforpoly(lacticacid),thesepolymersarecommonlyreferredtoasPGA,PLA,andPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.PLAisatermthatcarriesnostereoisomericspecificityandthereforeencompassesboththeamorphousatactic/syndiotacticdl-lactidebasedpolymersandcopolymersaswellastheisotacticd-PLAandl-PLAmoieties,eachofwhichcarriespotentialforcrystallization.Inclusionofstereoisomericspecificitywithinthelacticacidbasedacronymsresultsinthefollowing:poly(l-lactide)asPlLAforpoly(l-lacticacid),poly(d-lactide)asPdLAforpoly(d-lacticacid),andpoly(dl-lactide)asPdlLAforpoly(dl-lacticacid).1.3Thisspecificationisapplicabletolactide-basedpolymersorcopolymersthatpossessisotacticpolymericsegmentssufficientinsizetocarrypotentialforlactide-basedcrystallization.Suchpolymerstypicallypossessnominalmolefractionsthatequalorexceed50%l-lactide.Thisspecificationisparticularlyapplicabletoisotactic-lactidebasedblockcopolymersortopolymersorcopolymerssynthesizedfromcombinationsofd-lactideandl-lactidethatdifferbymorethan1.5totalmolepercent(1.5%oftotalmoles).Thisspecificationisnotapplicabletolactide-co-glycolidecopolymerswithglycolidemolefractionsgreaterthanorequalto70%(65.3%inmassfraction),whicharecoveredbySpecificationF2313.Thisspecificationisnotapplicabletoamorphouspolymersorcopolymerssynthesizedfromcombinationsofd-lactideandl-lactidethatdifferbylessthan1.5totalmolepercent(1.5%oftotalmoles)ascoveredbySpecificationF2579.1.4Thisspecificationcoversvirginsemi-crystallinepoly(lactide)-basedresinsabletobefullysolvatedat30x00B0;Cbyeithermethylenechloride(dichloromethane)orchloroform(trichloromethane).Thisspecificationisnotapplicabletolactide:glycolidecopolymersthatpossessglycolidesegmentssufficientinsizetodeliverpotentialforglycolide-basedcrystallization,therebyrequiringfluorinatedsolventsforcompletedissolutionunderroomtemperatureconditions(seeSpecificationF2313).1.5Withinthisspecification,semi-crystallinitywithintheresinisdefinedbythepresenceofaDSC(differentialscanningcalorimetry)crystallineendothermafterannealingabovetheglasstransitiontemperature.Whileothercopolymerics......
【中国标准分类号】:C45
【国际标准分类号】:83_080_20
【页数】:9P.;A4
【正文语种】:英语