ASTM F2579-2006e1 外科植入物用无定型的聚丙交酯和丙交酯乙交酯共聚物树脂的标准规范
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【英文标准名称】:StandardSpecificationforAmorphousPoly(lactide)andPoly(lactide-co-glycolide)ResinsforSurgicalImplants
【原文标准名称】:外科植入物用无定型的聚丙交酯和丙交酯乙交酯共聚物树脂的标准规范
【标准号】:ASTMF2579-2006e1
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:无定型的;树脂;外科植入物
【英文主题词】:PGA:PLA;PLA;PLA:PGA;PLGA;polyglycolic:lacticacid;poly(glycolide-co-lactide);poly(glycolide:lactide);poly(lacticacid);polylactic:glycolicacid;poly(lactide);poly(lactide-co-glycolide);poly(lactide:glycolide)
【摘要】:1.1Thisspecificationcoversvirginpoly(lactide)andpoly(lactide-co-glycolide)resinsabletobefullysolvatedat30176;Cbyeithermethylenechloride(dichloromethane)orchloroform(trichloromethane).Thepoly(d,l-lactide)homopolymerscoveredbythisspecificationareconsideredtobeamorphous(thatis,voidofcrystallinity)andarepolymerizedeitherfrommeso-lactideorfromequimolar(racemic)combinationsofd-lactideandl-lactide.Thepoly(d,l-lactide-co-glycolide)copolymerscoveredbythisspecificationarealsoconsideredtobeamorphousandareco-polymerizedfromacombinationofglycolideandeithermeso-lactideorracemicquantitiesofd-lactideandl-lactide,andtypicallypossessnominalmolefractionsthatequalorexceed50%lactide.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbreviatedasPLAforpoly(lacticacid),thesepolymersarecommonlyreferredtoasPGA,PLA,andPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.PLAisatermthatcarriesnoenantiomericspecificityandthereforealsoencompassestheisotacticd-PLAandl-PLAmoieties,eachofwhichcarriespotentialforcrystallization.Therefore,specificreferencetod,l-PLAisessentialtoappropriatelydifferentiatetheamorphousatactic/syndiotacticd,l-lactidebasedpolymersandcopolymerscoveredbythisspecification.1.3Thisspecificationisnotapplicabletolactidebasedpolymersorcopolymersthatpossessisotacticpolymericsegmentssufficientinsizetodeliverpotentialforlactidebasedcrystallization.Thisspecificationisnotapplicabletolactide-co-glycolidecopolymersthatpossessglycolidesegmentssufficientinsizetodeliverpotentialforglycolidebasedcrystallization,therebyrequiringfluorinatedsolventsforcompletedissolutionunderroomtemperatureconditions.Thisspecificationisspecificallynotapplicabletolactide-co-glycolidecopolymerswithglycolidemolefractionsgreaterthanorequalto70%(65.3%inmassfraction).Thisspecificationisnotapplicabletoblockcopolymersortopolymersorcopolymerssynthesizedfromcombinationsofd-lactideandl-lactidethatdifferbymorethan1.5totalmolepercent(1.5%oftotalmoles).1.4Thisspecificationaddressesmaterialcharacteristicsofbothpoly(lactide)andpoly(lactide-co-glycolide)resinsintendedforuseinsurgicalimplantsanddoesnotapplytopackagedandsterilizedfinishedimplantsfabricatedfromthesematerials.1.5Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,etc.)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthisresinshouldbeevaluatedindependentlyusingappropriatetestmethodstoassuresafetyandefficacy.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40;11_040_40
【页数】:10P.;A4
【正文语种】:
【原文标准名称】:外科植入物用无定型的聚丙交酯和丙交酯乙交酯共聚物树脂的标准规范
【标准号】:ASTMF2579-2006e1
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:无定型的;树脂;外科植入物
【英文主题词】:PGA:PLA;PLA;PLA:PGA;PLGA;polyglycolic:lacticacid;poly(glycolide-co-lactide);poly(glycolide:lactide);poly(lacticacid);polylactic:glycolicacid;poly(lactide);poly(lactide-co-glycolide);poly(lactide:glycolide)
【摘要】:1.1Thisspecificationcoversvirginpoly(lactide)andpoly(lactide-co-glycolide)resinsabletobefullysolvatedat30176;Cbyeithermethylenechloride(dichloromethane)orchloroform(trichloromethane).Thepoly(d,l-lactide)homopolymerscoveredbythisspecificationareconsideredtobeamorphous(thatis,voidofcrystallinity)andarepolymerizedeitherfrommeso-lactideorfromequimolar(racemic)combinationsofd-lactideandl-lactide.Thepoly(d,l-lactide-co-glycolide)copolymerscoveredbythisspecificationarealsoconsideredtobeamorphousandareco-polymerizedfromacombinationofglycolideandeithermeso-lactideorracemicquantitiesofd-lactideandl-lactide,andtypicallypossessnominalmolefractionsthatequalorexceed50%lactide.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbreviatedasPLAforpoly(lacticacid),thesepolymersarecommonlyreferredtoasPGA,PLA,andPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.PLAisatermthatcarriesnoenantiomericspecificityandthereforealsoencompassestheisotacticd-PLAandl-PLAmoieties,eachofwhichcarriespotentialforcrystallization.Therefore,specificreferencetod,l-PLAisessentialtoappropriatelydifferentiatetheamorphousatactic/syndiotacticd,l-lactidebasedpolymersandcopolymerscoveredbythisspecification.1.3Thisspecificationisnotapplicabletolactidebasedpolymersorcopolymersthatpossessisotacticpolymericsegmentssufficientinsizetodeliverpotentialforlactidebasedcrystallization.Thisspecificationisnotapplicabletolactide-co-glycolidecopolymersthatpossessglycolidesegmentssufficientinsizetodeliverpotentialforglycolidebasedcrystallization,therebyrequiringfluorinatedsolventsforcompletedissolutionunderroomtemperatureconditions.Thisspecificationisspecificallynotapplicabletolactide-co-glycolidecopolymerswithglycolidemolefractionsgreaterthanorequalto70%(65.3%inmassfraction).Thisspecificationisnotapplicabletoblockcopolymersortopolymersorcopolymerssynthesizedfromcombinationsofd-lactideandl-lactidethatdifferbymorethan1.5totalmolepercent(1.5%oftotalmoles).1.4Thisspecificationaddressesmaterialcharacteristicsofbothpoly(lactide)andpoly(lactide-co-glycolide)resinsintendedforuseinsurgicalimplantsanddoesnotapplytopackagedandsterilizedfinishedimplantsfabricatedfromthesematerials.1.5Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,etc.)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthisresinshouldbeevaluatedindependentlyusingappropriatetestmethodstoassuresafetyandefficacy.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40;11_040_40
【页数】:10P.;A4
【正文语种】:
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