ASTM F2759-2009 对超高分子量聚乙烯评估(UHMWPE)用于脊柱骨科和设备的标准指南
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【英文标准名称】:StandardGuideforAssessmentoftheUltraHighMolecularWeightPolyethylene(UHMWPE)UsedinOrthopedicandSpinalDevices
【原文标准名称】:对超高分子量聚乙烯评估(UHMWPE)用于脊柱骨科和设备的标准指南
【标准号】:ASTMF2759-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:
【英文主题词】:musculoskeletaljointreplacement;orthopedicdevice;spinaldevice;UHMWPE;ultra-highmolecularweightpolyethylene
【摘要】:ThisguideaimstoprovideguidanceforarangeofvariousassessmentsandevaluationstoaidinpreclinicalresearchanddevicedevelopmentofvariousUHMWPEcomponentsinorthopedicandspinaldevicesusedfortherepairofmusculoskeletaldisorders.Thisguideincludesbriefdescriptionsofvariousassessments,representativedata,processingconditions,andintendeduseoruses,aswellasthequalitativeandquantitativeanalysesoftheUHMWPEpowdertoafinishedproductcomponent.TheuserisencouragedtouseappropriateASTMInternationalandotherstandardstoconductthephysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEmaterials,devicecomponents,ordevicesbeforeassessmentofaninvivomodel.AssessmentsofUHMWPEshouldbeperformedinaccordancewiththeprovisionsof21CFR58wherefeasible.Studiestosupportinvestigationaldeviceexemption(IDE),premarketapproval(PMA),or510KsubmissionsshouldconformtoappropriateFoodandDrugAdministration(FDA)guidelinesforthedevelopmentofmedicaldevices.Assessmentswithphysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEcomponentsarenotnecessarilypredictiveofhumanresultsandshouldbe,therefore,interpretedcautiouslywithrespecttopotentialapplicabilitytohumanconditions.ReferencedUHMWPEpublicationscanbefoundintheReferencessectionattheendofthisguideforfurtherreview.1.1Thisguidecoversgeneralguidelinesforthephysical,chemical,biocompatibility,mechanical,andpreclinicalassessmentsofultra-highmolecularweightpolyethylene(UHMWPE)inimplantableorthopedicandspinaldevicesintendedtoreplaceamusculoskeletaljoint.TheUHMWPEcomponentsmayincludeknee,hip,shoulder,elbow,ankle,totaldiscreplacement,toe,finger,andwristjointimplantdevices.ThisguidedoesnotcoverUHMWPEinfiberortapeforms.1.2ThisguideincludesadescriptionandrationaleofassessmentsforthevariousUHMWPEtypesandprocessingconditions.Assessmenttestingbasedonphysical,chemical,biocompatibility,mechanical,andpreclinicalanalysesarebrieflydescribedandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetails.1.3ThisguidedoesnotattempttodefinealloftheassessmentmethodsassociatedwithUHMWPEcomponentsinorthopedicandspinaldevices.1.4Units8212;ThevaluesgiveninSIunitsaretoberegardedasthestandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
【原文标准名称】:对超高分子量聚乙烯评估(UHMWPE)用于脊柱骨科和设备的标准指南
【标准号】:ASTMF2759-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:
【英文主题词】:musculoskeletaljointreplacement;orthopedicdevice;spinaldevice;UHMWPE;ultra-highmolecularweightpolyethylene
【摘要】:ThisguideaimstoprovideguidanceforarangeofvariousassessmentsandevaluationstoaidinpreclinicalresearchanddevicedevelopmentofvariousUHMWPEcomponentsinorthopedicandspinaldevicesusedfortherepairofmusculoskeletaldisorders.Thisguideincludesbriefdescriptionsofvariousassessments,representativedata,processingconditions,andintendeduseoruses,aswellasthequalitativeandquantitativeanalysesoftheUHMWPEpowdertoafinishedproductcomponent.TheuserisencouragedtouseappropriateASTMInternationalandotherstandardstoconductthephysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEmaterials,devicecomponents,ordevicesbeforeassessmentofaninvivomodel.AssessmentsofUHMWPEshouldbeperformedinaccordancewiththeprovisionsof21CFR58wherefeasible.Studiestosupportinvestigationaldeviceexemption(IDE),premarketapproval(PMA),or510KsubmissionsshouldconformtoappropriateFoodandDrugAdministration(FDA)guidelinesforthedevelopmentofmedicaldevices.Assessmentswithphysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEcomponentsarenotnecessarilypredictiveofhumanresultsandshouldbe,therefore,interpretedcautiouslywithrespecttopotentialapplicabilitytohumanconditions.ReferencedUHMWPEpublicationscanbefoundintheReferencessectionattheendofthisguideforfurtherreview.1.1Thisguidecoversgeneralguidelinesforthephysical,chemical,biocompatibility,mechanical,andpreclinicalassessmentsofultra-highmolecularweightpolyethylene(UHMWPE)inimplantableorthopedicandspinaldevicesintendedtoreplaceamusculoskeletaljoint.TheUHMWPEcomponentsmayincludeknee,hip,shoulder,elbow,ankle,totaldiscreplacement,toe,finger,andwristjointimplantdevices.ThisguidedoesnotcoverUHMWPEinfiberortapeforms.1.2ThisguideincludesadescriptionandrationaleofassessmentsforthevariousUHMWPEtypesandprocessingconditions.Assessmenttestingbasedonphysical,chemical,biocompatibility,mechanical,andpreclinicalanalysesarebrieflydescribedandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetails.1.3ThisguidedoesnotattempttodefinealloftheassessmentmethodsassociatedwithUHMWPEcomponentsinorthopedicandspinaldevices.1.4Units8212;ThevaluesgiveninSIunitsaretoberegardedasthestandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
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