【英文标准名称】:StandardGuideforFunctional,Kinematic,andWearAssessmentofTotalDiscProstheses
【原文标准名称】:总脊面假体的功能的、运动学的和磨损的评估标准指南
【标准号】:ASTMF2423-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:(Guide)
【标准水平】:()
【中文主题词】:评估;函数;运动学的;总计;磨损
【英文主题词】:intervertebraldiscprosthesis;IVD;spinalimplants;wearassessment;weightlossmethod
【摘要】:Thisguidecanbeusedtodescribethefunction,kinematics,andwearbehaviorofIVDprosthesessubjectedtocyclicloading/motionforrelativelylargenumbersofcycles(forexample,variousdesignsofIVDprostheses,aswellastheeffectsofmaterials,manufacturingtechniquesandotherdesignvariablesononeparticulardesigncanbestudiedusingthisguide).ThisguideisintendedtobeapplicabletoIVDprosthesesthatsupportandtransmitmotionbymeansofanarticulatingjointorbyuseofcompliantmaterials.Ceramics,metals,orpolymers,orcombinationthereof,areusedinIVDprosthesisdesign,anditisthegoalofthisguidetoenableakinematicwearcomparisonofthesedevices,regardlessofmaterialandtypeofdevice.1.1Thisguideisintendedtoprovideguidanceforthefunctional,kinematic,andweartestingoftotaldiscprosthesesand,tothisend,describestestmethodsforassessmentofthewearorfunctionalcharacteristics,orboth,oftotaldiscprostheses.1.2Bothlumbarandcervicalprosthesesareaddressed.1.3Loadandkinematicprofilesforlumbarandcervicaldevicesarenotidenticaland,therefore,areaddressedseparatelyintheguide.1.4Partialdiscreplacements,suchasnucleusreplacementsorfacetjointreplacements,arenotintendedtobeaddressed.1.5Wearisassessedusingaweightlossmethodinatestingmediumasdefinedinthisguide.1.6Thisguideisnotintendedtoaddressanypotentialfailuremodeasitrelatestothefixationoftheimplanttoitsbonyinterfaces.1.7Itistheintentofthisguidetoenablecomparisonofintervertebraldisc(IVD)prostheseswithregardtokinematic,functional,andwearcharacteristicswhentestedunderthespecifiedconditions.Itmustberecognized,however,thattherearemanypossiblevariationsintheinvivoconditions.Asinglelaboratorysimulationwithafixedsetofparametersmaynotbeuniversallyrepresentative.1.8Inorderthatthedatabereproducibleandcomparablewithinandbetweenlaboratories,itisessentialthatuniformproceduresareestablished.Thisguideisintendedtofacilitateuniformmethodsfortestingandreportingofdatafortotaldiscreplacementprostheses.1.9WithoutasubstantialclinicalretrievalhistoryofIVDprostheses,actualloadingprofilesandpatternscannotbedelineatedatthetimeofthewritingofthisguide.Itthereforefollowsthattheloadandmotionconditionsspecifiedbythisguidedonotnecessarilyaccuratelyreproducethoseoccurringinvivo.Rather,themaximumloadsandmotionsspecifiedinthisguiderepresentasevereandthereforeconservativecasefortestingthewearpropertiesofIVDprostheses.Becauseofthis,asubstantiallygreaterrateofwearmayberealizedthanthatwhichmayoccurduringtheroutinedailyactivitiesofatypicalpatient.Itshouldbenoted,however,thatafullcharacterizationofacandidateIVDprosthesisshouldincludetestingunderbothtypicalandextremeconditions.1.10ThevaluesstatedinSIunitsaretoberegardedasthestandardwiththeexceptionofangularmeasurements,whichmaybereportedineitherdegreesorradians.1.11Thisguideisnotintendedtobeaperformancestandard.Itistheresponsibilityoftheuserofthisguidetocharacterizethesafetyandeffectivenessoftheprosthesisunderevaluation.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:


【英文标准名称】:Explosivesforciviluses-Propellantsandrocketpropellants-Part4:determinationofburningrateunderambientconditions.
【原文标准名称】:民用爆炸物.推进剂和火箭推进剂.第4部分:大气条件下燃烧速率的测定
【标准号】:NFT70-938-4-2004
【标准状态】:现行
【国别】:法国
【发布日期】:2004-03-01
【实施或试行日期】:2004-03-05
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:试验装置;推进剂;稳定性;爆炸作用;定义;燃烧速度;非电子的;易燃物质;温度范围;电的;转换时间;环境条件;材料试验;粒度;火箭推进剂;安全;试验;采掘;试样制备;黑色粉末;炸药;点火器
【英文主题词】:
【摘要】:
【中国标准分类号】:G89
【国际标准分类号】:71_100_30
【页数】:10P;A4
【正文语种】:其他