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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】:ASTMF1839-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:F04.21
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bone;cellularplastic;medicaldevices;polyurethane;rigidfoam;Orthopaedicmedicaldevices--specifications;Polyurethane--surgicalapplications;Rigidfoam
【摘要】:Thisspecificationdescribesthecompositionalrequirements,physicalrequirements,mechanicalrequirements,andtestmethodsforrigidunicellularpolyurethanefoamforuseintestingorthopaedicdevicesorinstruments.Thisfoamdescribedinthisspecificationisnotintendedtoreplicatethemechanicalpropertiesofhumanoranimalbone.Therequirementsofthisspecificationareintendedtoprovideaconsistentanduniformmaterialwithpropertiesontheorderofhumancancellousbonetouseasatestmediumwhentestingvariousorthopaedicdevices,suchasbonescrews.1.1Thisspecificationcoversrigidunicellularpolyurethanefoamforuseasastandardmaterialforperformingmechanicaltestsutilizingorthopaedicdevicesorinstruments.Thespecificationisapplicabletosheetsorblocksoffoam,orfoamthatismadebytheuserusingatwo-partliquidmixture.1.2Thisspecificationcoverspolyurethanefoammaterialthatisusedinthelaboratoryformechanicaltesting,asdescribedin1.1.Thesematerialsarenotintendedforimplantationintothehumanbody.1.3Thefoamdescribedhereinpossessesmechanicalpropertieswhichareontheorderofthosereportedforhumancancellousbone.SeeAppendixX1Rationaleforfurtherinformationregardingtheappropriatenessofusingthespecifiedfoamasamodelforhumancancellousbone.1.4Thisspecificationcoverscompositionalrequirements,physicalrequirements,mechanicalrequirements,andtestmethodsforrigidpolyurethanefoaminthesolidfinalform.1.5Thisspecificationprovidesqualificationcriteriaforvendororend-userprocessesandacceptancecriteriaforindividualmateriallots.1.6Thisspecificationprovidesmechanicalpropertiesoffivedifferentgradesoffoaminthesolidfinalform.Afoamthatdoesnotmeetthespecifiedmechanicalpropertiesshallbeidentifiedasanungradedfoam.1.7ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.8Thefollowingprecautionarystatementpertainstothetestmethodportiononly,Section8,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_01
【页数】:6P.;A4
【正文语种】:英语