ASTM F624-2009 评定医学用热塑性聚氨基甲酸乙酯固体及溶液的标准指南
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【英文标准名称】:StandardGuideforEvaluationofThermoplasticPolyurethaneSolidsandSolutionsforBiomedicalApplications
【原文标准名称】:评定医学用热塑性聚氨基甲酸乙酯固体及溶液的标准指南
【标准号】:ASTMF624-2009
【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】:plasticsurgicaldevices/applications;polymers-surgicalapplications;polyurethane-medicalapplications;Plasticsurgicaldevices/applications;Polymers(surgicalapplications);Polyurethane--surgicalapplications;Thermoplasticsurgicalimplantapplic
【摘要】:Thisguideisintendedtoaiddevicefabricatorsintheselectionofpropercommerciallyavailablepolyurethanesolidsandsolutionsfortheirapplication.Thepolyurethanescoveredbythisguidemaybethermoformedorsolutioncastintobiomedicaldevicesforuseassurgicalaidsorforimplantationasdeterminedtobeappropriate,basedonsupportingbiocompatibilityandphysicaltestdata.1.1Thisguidecoverstheevaluationofthermoplasticpolyurethanesinbothsolidandsolutionformforbiomedicalapplications.Thepolymershavebeenreactedtocompletionandrequirenofurtherchemicalprocessing.1.2Thetestsandmethodslistedinthisguidemaybereferencedinspecificationcontainingminimumrequiredvaluesandtolerancesforspecificend-useproducts.1.3Standardtestsforbiocompatibilityareincludedtoaidintheassessmentofsafeutilizationinbiomedicalapplications.Compliancewiththesecriteriashallnotbeconstruedasanendorsementofimplantability.Sincemanycompositions,formulations,andformsofthermoplasticpolyurethanesinsolidandsolutionformsarewithinthismaterialclass,theformulatororfabricatormustevaluatethebiocompatibilityofthespecificcompositionorformintheintendeduseandaftercompletionofallmanufacturingprocessesincludingsterilization.1.4Purchasespecificationsmaybepreparedbyagreementbetweenthebuyerandsellerbyselectionofappropriatetestsandmethodsfromthoselistedapplicabletothespecificbiomedicalenduse.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:83_080_20
【页数】:4P.;A4
【正文语种】:英语
【原文标准名称】:评定医学用热塑性聚氨基甲酸乙酯固体及溶液的标准指南
【标准号】:ASTMF624-2009
【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】:plasticsurgicaldevices/applications;polymers-surgicalapplications;polyurethane-medicalapplications;Plasticsurgicaldevices/applications;Polymers(surgicalapplications);Polyurethane--surgicalapplications;Thermoplasticsurgicalimplantapplic
【摘要】:Thisguideisintendedtoaiddevicefabricatorsintheselectionofpropercommerciallyavailablepolyurethanesolidsandsolutionsfortheirapplication.Thepolyurethanescoveredbythisguidemaybethermoformedorsolutioncastintobiomedicaldevicesforuseassurgicalaidsorforimplantationasdeterminedtobeappropriate,basedonsupportingbiocompatibilityandphysicaltestdata.1.1Thisguidecoverstheevaluationofthermoplasticpolyurethanesinbothsolidandsolutionformforbiomedicalapplications.Thepolymershavebeenreactedtocompletionandrequirenofurtherchemicalprocessing.1.2Thetestsandmethodslistedinthisguidemaybereferencedinspecificationcontainingminimumrequiredvaluesandtolerancesforspecificend-useproducts.1.3Standardtestsforbiocompatibilityareincludedtoaidintheassessmentofsafeutilizationinbiomedicalapplications.Compliancewiththesecriteriashallnotbeconstruedasanendorsementofimplantability.Sincemanycompositions,formulations,andformsofthermoplasticpolyurethanesinsolidandsolutionformsarewithinthismaterialclass,theformulatororfabricatormustevaluatethebiocompatibilityofthespecificcompositionorformintheintendeduseandaftercompletionofallmanufacturingprocessesincludingsterilization.1.4Purchasespecificationsmaybepreparedbyagreementbetweenthebuyerandsellerbyselectionofappropriatetestsandmethodsfromthoselistedapplicabletothespecificbiomedicalenduse.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:83_080_20
【页数】:4P.;A4
【正文语种】:英语
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