【英文标准名称】:StandardSpecificationforPoly(glycolide)andPoly(glycolide-co-lactide)ResinsforSurgicalImplantswithMoleFractionsGreaterThanorEqualto70%Glycolide
【原文标准名称】:摩尔分数大于或等于70%乙二醇的外科植入物用聚乙二醇和聚乙二醇聚乳酸树脂的标准规范
【标准号】:ASTMF2313-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:poly(glycolicacid);poly(glycolide);PGA;poly(glycolide:lactide);poly(glycolide-co-lactide);PLA;PGA:PLA;polyglycolic:lacticacid;Poly(glycolicacid)(PGA);Poly(glycolide);Poly(glycolide-co-lactide);Polymers--specifications;Surgicalimplants--spe
【摘要】:1.1Thisspecificationcoversbothvirginpoly(glycolide)resinandpoly(glycolide-co-lactide)resinwithmolefractionsgreaterthanorequalto70%glycolide.Thisspecificationisnotapplicabletoglycolide:lactidecopolymerswithmolefractionsexceeding30%lactide.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbreviatedasPLAforpoly(lacticacid),thesepolymersarecommonlyreferredtoasPGAandPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.1.3Thisspecificationaddressesmaterialcharacteristicsofbothvirginpoly(glycolide)andpoly(>70%glycolide-co-lactide)resinsintendedforuseinsurgicalimplantsanddoesnotapplytopackagedandsterilizedfinishedimplantsfabricatedfromthesematerials.1.4Aswithanymaterial,somecharacteristicsmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthisresinshouldbeevaluatedindependentlyusingappropriatetestmethodstoensuresafetyandefficacy.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandardmaysuggestuseofhazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G31
【国际标准分类号】:83_080_10
【页数】:9P.;A4
【正文语种】:英语