ASTM F2193-2002(2007) 脊锥骨外科组织固定用构件的标准规范和试验方法

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【英文标准名称】:StandardSpecificationsandTestMethodsforComponentsUsedintheSurgicalFixationoftheSpinalSkeletalSystem
【原文标准名称】:脊锥骨外科组织固定用构件的标准规范和试验方法
【标准号】:ASTMF2193-2002(2007)
【标准状态】:现行
【国别】:美国
【发布日期】:2002
【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】:F04.25
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:bendtesting-plate;bendtesting-rod;bendtesting-screw;bendtesting-surgicalimplants;fatiguetest-plate;fatiguetest-rod;fatiguetest-screw;fatiguetest-surgicalimplants;orthopedicmedicaldevice-plate;orthopedicmedicaldevice-rod;orthopedic
【摘要】:1.1Thesespecificationsandtestmethodsareintendedtoprovideacomprehensivereferenceforthecomponentsofsystemsusedinthesurgicalfixationofthespinalskeletalsystem.Thedocumentcatalogsstandardspecificationsthatspecifymaterial,labeling,andhandlingrequirements.Thespecificationsandtestmethodsalsoestablishcommonterminologythatcanbeusedtodescribethesizeandotherphysicalcharacteristicsofspinalcomponentsandperformancedefinitionsrelatedtotheperformanceofspinalcomponents.Additionally,thespecificationsandtestmethodsestablishperformancerequirementsandstandardtestmethodstoconsistentlymeasureperformance-relatedmechanicalcharacteristicsofspinalcomponents.1.2Thesespecificationsandtestmethodsareaseriesofstandardsavailableforaddressingtheconcernsrelatedtosystemsusedinthesurgicalfixationofthespinalskeletalsystem.Thesespecificationsandtestmethodsconcentrateontheindividualcomponents,whicharefoundinmanyspinalfixationsystems.Iftheuserisinterestedinevaluatingthenextlevelinthespinalfixationsystemchain,theinterconnectionsbetweenindividualcomponentsandsubassemblies(twoormorecomponents),theusershouldconsultGuideF1798.AtthehighestlevelinthischainisTestMethodsF1717,whichisusedtoevaluateanentireconstructassembledfrommanycomponentsandinvolvesnumerousinterconnectionsandseveralsubassemblies.1.3Itisnottheintentionofthesespecificationsandtestmethodstodefinelevelsofperformanceorcase-specificclinicalperformanceforspinalcomponentsaddressedbythisdocument.Insufficientknowledgeisavailabletopredicttheconsequencesofusinganyofthesecomponentsinindividualpatientsforspecificactivitiesofdailyliving.Furthermore,itisnottheintentionofthisdocumenttodescribeorspecifyspecificdesignsfortheindividualcomponentsofsystemsusedinthesurgicalinternalfixationofthespinalskeletalsystem.1.4Thesespecificationsandtestmethodsmaynotbeappropriateforalltypesofspinalsurgicalfixationsystems.Theuseriscautionedtoconsidertheappropriatenessofthisdocumentinviewoftheparticularimplantsystemanditspotentialapplication.1.5Thisdocumentincludesthefollowingspecificationsandtestmethodsthatareusedindeterminingthespinalcomponent''smechanicalperformancecharacteristics:1.5.1SpecificationforMetallicSpinalScrews8212;AnnexA1.1.5.2SpecificationforMetallicSpinalPlates8212;AnnexA2.1.5.3SpecificationforMetallicSpinalRods8212;AnnexA3.1.5.4TestMethodforMeasuringtheStaticandFatigueBendingStrengthofMetallicSpinalScrews8212;AnnexA4.1.6Unlessotherwiseindicated,thevaluesstatedinSIunitsshallberegardedasthestandard.1.7Thisstandardmayinvolvehazardousmaterials,operations,andequipment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:14P.;A4
【正文语种】:英语