ASTM F1839-2001(2007) 作为测试矫形装置和仪器的标准物质的硬质聚氨酯泡沫的标准规范
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【英文标准名称】:StandardSpecificationforRigidPolyurethaneFoamforUseasaStandardMaterialforTestingOrthopedicDevicesandInstruments
【原文标准名称】:作为测试矫形装置和仪器的标准物质的硬质聚氨酯泡沫的标准规范
【标准号】:ASTMF1839-2001(2007)
【标准状态】:现行
【国别】:
【发布日期】:2001
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:骨骼;医疗产品;矫形外科学;聚氨酯;硬质泡沫塑料;测试
【英文主题词】:bone;cellularplastic;medicaldevices;polyurethane;rigidfoam;
【摘要】:1.1Thisspecificationcoversrigidunicellularpolyurethanefoamforuseasastandardmaterialforperformingmechanicaltestsutilizingorthopedicdevicesorinstruments.Thespecificationisapplicabletosheetsorblocksoffoam,orfoamthatismadebytheuserusingatwo-partliquidmixture.1.2Thisspecificationcoverspolyurethanefoammaterialthatisusedinthelaboratoryformechanicaltesting,asdescribedin.Thesematerialsarenotintendedforimplantationintothehumanbody.1.3Thefoamdescribedhereinpossessesmechanicalpropertieswhichareontheorderofthosereportedforhumancancellousbone.SeeAppendixX1Rationaleforfurtherinformationregardingtheappropriatenessofusingthespecifiedfoamasamodelforhumancancellousbone.1.4Thisspecificationcoverscompositionalrequirements,physicalrequirements,mechanicalrequirements,andtestmethodsforrigidpolyurethanefoaminthesolidfinalform.1.5Thisspecificationprovidesqualificationcriteriaforvendororend-userprocessesandacceptancecriteriaforindividualmateriallots.1.6Thisspecificationprovidesmechanicalpropertiesoffivedifferentgradesoffoaminthesolidfinalform.Afoamthatdoesnotmeetthespecifiedmechanicalpropertiesshallbeidentifiedasanungradedfoam.1.7Unlessotherwiseindicated,thevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesinparenthesesaregivenforinformationonly.Thefollowingprecautionarystatementpertainstothetestmethodportiononly,Section8,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G32
【国际标准分类号】:11_040_01
【页数】:6P.;A4
【正文语种】:
【原文标准名称】:作为测试矫形装置和仪器的标准物质的硬质聚氨酯泡沫的标准规范
【标准号】:ASTMF1839-2001(2007)
【标准状态】:现行
【国别】:
【发布日期】:2001
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:骨骼;医疗产品;矫形外科学;聚氨酯;硬质泡沫塑料;测试
【英文主题词】:bone;cellularplastic;medicaldevices;polyurethane;rigidfoam;
【摘要】:1.1Thisspecificationcoversrigidunicellularpolyurethanefoamforuseasastandardmaterialforperformingmechanicaltestsutilizingorthopedicdevicesorinstruments.Thespecificationisapplicabletosheetsorblocksoffoam,orfoamthatismadebytheuserusingatwo-partliquidmixture.1.2Thisspecificationcoverspolyurethanefoammaterialthatisusedinthelaboratoryformechanicaltesting,asdescribedin.Thesematerialsarenotintendedforimplantationintothehumanbody.1.3Thefoamdescribedhereinpossessesmechanicalpropertieswhichareontheorderofthosereportedforhumancancellousbone.SeeAppendixX1Rationaleforfurtherinformationregardingtheappropriatenessofusingthespecifiedfoamasamodelforhumancancellousbone.1.4Thisspecificationcoverscompositionalrequirements,physicalrequirements,mechanicalrequirements,andtestmethodsforrigidpolyurethanefoaminthesolidfinalform.1.5Thisspecificationprovidesqualificationcriteriaforvendororend-userprocessesandacceptancecriteriaforindividualmateriallots.1.6Thisspecificationprovidesmechanicalpropertiesoffivedifferentgradesoffoaminthesolidfinalform.Afoamthatdoesnotmeetthespecifiedmechanicalpropertiesshallbeidentifiedasanungradedfoam.1.7Unlessotherwiseindicated,thevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesinparenthesesaregivenforinformationonly.Thefollowingprecautionarystatementpertainstothetestmethodportiononly,Section8,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G32
【国际标准分类号】:11_040_01
【页数】:6P.;A4
【正文语种】:
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