【英文标准名称】:StandardGuideforExtensivelyIrradiation-CrosslinkedUltra-HighMolecularWeightPolyethyleneFabricatedFormsforSurgicalImplantApplications
【原文标准名称】:外科植入物用交联超高分子量聚乙烯加工式样外延辐照的标准指南
【标准号】:ASTMF2565-2006
【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(US-ASTM)
【起草单位】:F04.11
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:交联;辐照;分子量;聚乙烯;外科植入物;超高分子;重量
【英文主题词】:fabricatedforms;powderedform;ultra-highmolecularweightpolyethylene
【摘要】:1.1Thisguidecoversextensivelycrosslinkedultra-highmolecularweightpolyethylene(UHMWPE)materials(fabricatedforms)thatareproducedstartingwithvirginresinpowdersandconsolidatedformsmeetingalltherequirementsofTestMethodF648.1.2Thisguidedoesnotcoverfabricatedformsofultra-highmolecularweightpolyethylenewhichhavereceivedonlygasplasma,ethyleneoxide,orlessthan40kGyionizingradiationtreatments,thatis,materialstreatedonlybyhistoricalsterilizationmethods.1.3ThisguidepertainsonlytoUHMWPEmaterialsextensivelycrosslinkedbygammaandelectronbeamsourcesofionizingradiation.1.4Thespecificrelationshipsbetweenthesemechanicalpropertiesandtheinvivoperformanceofafabricatedformhavenotbeendetermined.Whiletrendsareapparent,specificproperty-polymerstructureandpolymer-designrelationshipsarenotwellunderstood.Thesemechanicaltestsarefrequentlyusedtoevaluatethereproducibilityofafabricationprocedureandareapplicableforcomparativestudiesofdifferentmaterials.1.5Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section5,ofthisguide.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40;83_080_10
【页数】:4P.;A4
【正文语种】: