【英文标准名称】:StandardSpecificationforVirginPoly(L-LacticAcid)ResinforSurgicalImplants
【原文标准名称】:外科植入物用直馏聚(L-乳酸)树脂的标准规范
【标准号】:ASTMF1925-1999(2005)
【标准状态】:现行
【国别】:
【发布日期】:1999
【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】:医疗技术学;直馏聚酯;PLLA;人造树脂;聚(L-乳酸);质量要求;外科植入物
【英文主题词】:PLLA;poly(L-lacticacid);polylactide;virginpolymer
【摘要】:1.1Thisspecificationcoversvirginpoly(L-lacticacid)resin(orabbreviatedasPLLAresin)intendedforuseinsurgicalimplants.ThisspecificationdoesnotcoverstereoisomericcompositionbasedonvariousD,L,DLcopolymerratios.1.2Thisspecificationaddressesmaterialcharacteristicsofvirginpoly(L-lacticacid)resinanddoesnotapplytopackagedandsterilizedfinishedimplantsfabricatedfromthismaterial.1.3Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,etc.)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthisresinshouldbeevaluatedusingthosetestmethodswhichareappropriatetoassuresafetyandefficacy.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.5Thefollowingprecautionarystatementpertainsonlytothetestmethodportion,Section6,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40;83_080_20
【页数】:4P.;A4
【正文语种】: