【英文标准名称】:StandardSpecificationandTestMethodsforBioabsorbablePlatesandScrewsforInternalFixationImplants
【原文标准名称】:内部安装植入物用生物可吸收板和螺钉的标准规范和试验方法
【标准号】:ASTMF2502-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bendtesting;boneplates;bonescrew;dimensions;insertion;pullout;shear;torsion
【摘要】:Biodegradabledevicesareexpectedbyintentiontodeteriorateovertimeoncetheyareimplantedintothebody.Thismakestheremovaloperationobsolete,whichisadvantageousespeciallyforpediatrics.Whilethepolymerdegradesduetohydrolyticreactionwiththeenvironment,themechanicalperformanceofthedevicealsodeteriorates.Thekeytodevelopingeffectivefracturefixationsystemsbasedonbiodegradabledevicesistoprovideanadequateleveloffixationstrengthforatimeframethatexceedsthatexpectedforfracturehealing.Oncethefractureishealed,thedevicecanbecompletelyresorbedbythebody.Generally,biodegradabledeviceswillbetestedwithsimilartestmethodsthatareusedtoevaluateconventionalmetallicdevices.Inaddition,onehastotakeintoconsiderationthepre-testconditioningrequirements,handlingrequirements,andtime-dependentmechanicalpropertyevaluationsforbiodegradabledevices.FIG.1ScrewParameters1.1Thisspecificationandtestmethodscoversamechanicalcharacterizationreferenceforhydrolyticallydegradablepolymerresin(fromthispointonreferencedas"bioabsorbable")platesandscrewsfororthopedicinternalfixation.1.2Thisspecificationestablishescommonterminologytodescribethesizeandotherphysicalcharacteristicsofbioabsorbableimplantsandperformancedefinitionsrelatedtotheperformanceofbioabsorbabledevices.1.3Thisspecificationestablishesstandardtestmethodstoconsistentlymeasureperformance-relatedmechanicalcharacteristicsofbioabsorbabledeviceswhentestedunderdefinedconditionsofpretreatment,temperature,humidity,andtestingmachinespeed.1.4Thisspecificationmaynotbeappropriateforallbioabsorbabledevices.Theuseriscautionedtoconsidertheappropriatenessofthestandardinviewoftheparticularbioabsorbabledeviceanditspotentialapplication.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:11P.;A4
【正文语种】: