ASTM F2102-2006e1 评定外科植入物用超高分子量聚乙烯加工式样氧化程度的标准指南
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【英文标准名称】:StandardGuideforEvaluatingtheExtentofOxidationinUltra-High-Molecular-WeightPolyethyleneFabricatedFormsIntendedforSurgicalImplants
【原文标准名称】:评定外科植入物用超高分子量聚乙烯加工式样氧化程度的标准指南
【标准号】:ASTMF2102-2006e1
【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】:F04.15
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:医疗技术学;聚乙烯;修复装置;规范
【英文主题词】:FTIR;implant;oxidation;oxidationindex;UHMWPE
【摘要】:1.1Thisguidecoversamethodforthemeasurementoftherelativeextentofoxidationpresentinultra-high-molecular-weightpolyethylene(UHMWPE)intendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.Theintensity(area)ofthecarbonylabsorptions(>C=O)centerednear1720cm-1isrelatedtotheamountofchemicallyboundoxygenpresentinthematerial.Otherformsofchemicallyboundoxygen(C-O-C,C-O-O-C,C-O-H,andsoforth)arenotcapturedbythisguide.1.2AlthoughthisguidemaygivetheinvestigatorameanstocomparetherelativeextentofcarbonyloxidationpresentinvariousUHMWPEsamples,itisrecognizedthatotherformsofchemicallyboundoxygenmaybeimportantcontributorstothesematerials''characteristics.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedbymanyliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenterednear1370cm-1tonormalizeforthesample''sthickness,hasbeenvalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section5,ofthisspecification:Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
【原文标准名称】:评定外科植入物用超高分子量聚乙烯加工式样氧化程度的标准指南
【标准号】:ASTMF2102-2006e1
【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】:F04.15
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:医疗技术学;聚乙烯;修复装置;规范
【英文主题词】:FTIR;implant;oxidation;oxidationindex;UHMWPE
【摘要】:1.1Thisguidecoversamethodforthemeasurementoftherelativeextentofoxidationpresentinultra-high-molecular-weightpolyethylene(UHMWPE)intendedforuseinmedicalimplants.Thematerialisanalyzedbyinfraredspectroscopy.Theintensity(area)ofthecarbonylabsorptions(>C=O)centerednear1720cm-1isrelatedtotheamountofchemicallyboundoxygenpresentinthematerial.Otherformsofchemicallyboundoxygen(C-O-C,C-O-O-C,C-O-H,andsoforth)arenotcapturedbythisguide.1.2AlthoughthisguidemaygivetheinvestigatorameanstocomparetherelativeextentofcarbonyloxidationpresentinvariousUHMWPEsamples,itisrecognizedthatotherformsofchemicallyboundoxygenmaybeimportantcontributorstothesematerials''characteristics.1.3Theapplicabilityoftheinfraredmethodhasbeendemonstratedbymanyliteraturereports.Thisparticularmethod,usingtheintensity(area)oftheC-Habsorptioncenterednear1370cm-1tonormalizeforthesample''sthickness,hasbeenvalidatedbyanInterlaboratoryStudy(ILS)conductedaccordingtoPracticeE691.1.4Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section5,ofthisspecification:Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:
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