ASTM F2381-2004 用红外线光谱法评价外科植入物用辐射超高分子量聚乙烯加工式样中反式亚乙烯屈服性的标准试验方法
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【英文标准名称】:StandardTestMethodforEvaluatingTrans-VinyleneYieldinIrradiatedUltra-High-Molecular-WeightPolyethyleneFabricatedFormsIntendedforSurgicalImplantsbyInfraredSpectroscopy
【原文标准名称】:用红外线光谱法评价外科植入物用辐射超高分子量聚乙烯加工式样中反式亚乙烯屈服性的标准试验方法
【标准号】:ASTMF2381-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:crosslinking;FTIR(FourierTransformInfrared);implant;trans-vinyleneindex;TVI;UHMWPE(ultra-high-molecular-weight-polyethylene)
【摘要】:Publishedliteratureshowsthattheyieldofradiolyticreactionsthatoccurduringradiationtreatmentincreaseswithradiationdoselevel.Measurementoftheproductsofthesereactionscanbeusedasaninternaldosimeter.Trans-vinyleneunsaturationsareformedduringionizationtreatmentbyabstractionofahydrogenmolecule,andtoalesserextentbytherecombinationoftwoadjacentalkylfreeradicalsthatresideonthesamechain.Previousworkgeneratedcalibrationcurvesoftrans-vinyleneabsorptionareaasafunctionofabsorbedradiationdose,yieldingalinearrelationshipforbothgamma-andelectronbeam-irradiatedpolyethylene.Thisdatacanbeusedtodeterminereceiveddoseasafunctionofposition,assumingacalibrationcurve(TVIversusradiationdoselevel)isknownfortheparticularmaterialandradiationconditionsused,andcanbeusedtodetermineuniformityofdoselevelinirradiatedpolyethylene.1.1Thistestmethoddescribesthemeasurementofthenumberoftrans-vinylenegroupsinultra-highmolecularweight-weightpolyethylene(UHMWPE)intendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.1.2ThistestmethodisbasedonGuideF2102.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedinotherliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenteredat1370cm-1tonormalizeforthesamplesthickness,willbevalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:
【原文标准名称】:用红外线光谱法评价外科植入物用辐射超高分子量聚乙烯加工式样中反式亚乙烯屈服性的标准试验方法
【标准号】:ASTMF2381-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:crosslinking;FTIR(FourierTransformInfrared);implant;trans-vinyleneindex;TVI;UHMWPE(ultra-high-molecular-weight-polyethylene)
【摘要】:Publishedliteratureshowsthattheyieldofradiolyticreactionsthatoccurduringradiationtreatmentincreaseswithradiationdoselevel.Measurementoftheproductsofthesereactionscanbeusedasaninternaldosimeter.Trans-vinyleneunsaturationsareformedduringionizationtreatmentbyabstractionofahydrogenmolecule,andtoalesserextentbytherecombinationoftwoadjacentalkylfreeradicalsthatresideonthesamechain.Previousworkgeneratedcalibrationcurvesoftrans-vinyleneabsorptionareaasafunctionofabsorbedradiationdose,yieldingalinearrelationshipforbothgamma-andelectronbeam-irradiatedpolyethylene.Thisdatacanbeusedtodeterminereceiveddoseasafunctionofposition,assumingacalibrationcurve(TVIversusradiationdoselevel)isknownfortheparticularmaterialandradiationconditionsused,andcanbeusedtodetermineuniformityofdoselevelinirradiatedpolyethylene.1.1Thistestmethoddescribesthemeasurementofthenumberoftrans-vinylenegroupsinultra-highmolecularweight-weightpolyethylene(UHMWPE)intendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.1.2ThistestmethodisbasedonGuideF2102.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedinotherliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenteredat1370cm-1tonormalizeforthesamplesthickness,willbevalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:
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