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【英文标准名称】:Prosthetics-Structuraltestingoflower-limbprostheses-Requirementsandtestmethods(ISO10328:2006);EnglishversionofDINENISO10328:2007-04
【原文标准名称】:修复术.假下肢的结构试验.要求和试验方法
【标准号】:DINENISO10328-2007
【标准状态】:现行
【国别】:德国
【发布日期】:2007-04
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:残疾人辅助器具;人造足;中心;合格;坐标系;定义;测定;精密机械;肢;纵向轴;假腿;医学科学;检验荷载;修复装置;规范(验收);样品;材料强度;强度试验;应力;结构;专门装备;试验装载;试验;试验条件;试验装置;试验准备工作;设计工作表
【英文主题词】:
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityoflowerlimbprostheticdevices/structureswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtoISO22675:2006.WARNING—ThisInternationalStandardisnotsuitabletoserveasaguidefortheselectionofaspecificlowerlimbprostheticdevice/structureintheprescriptionofanindividuallowerlimbprosthesis!Anydisregardofthiswarningcanresultinasafetyriskforamputees.ThisInternationalStandardspecifiesproceduresforstaticandcyclicstrengthtestsonlower-limbprostheses(seeNOTE2)whichtypicallyproducecompoundloadingsbytheapplicationofasingletestforce.Thecompoundloadsinthetestsamplerelatetothepeakvaluesofthecomponentsofloadingwhichnormallyoccuratdifferentinstantsduringthestancephaseofwalking.ThetestsdescribedinthisInternationalStandardcomprise—principalstaticandcyclictestsforallcomponents;—aseparatestatictestintorsionforallcomponents;—separatestaticandcyclictestsonankle-footdevicesandfootunitsforallankle-footdevicesassinglecomponentsincludingankleunitsorankleattachmentsandallfootunitsassinglecomponents;—aseparatestaticultimatestrengthtestinmaximumkneeflexiononkneejointsandassociatedpartsforallkneeunitsorknee-shin-assembliesandadjacentcomponentsthatnormallyprovidetheflexionstoponacompleteprosthesis;—separatestaticandcyclictestsonkneelocksforallmechanismswhichlockthekneejointintheextendedpositionofthekneeunitorknee-shin-assembly.ThetestsdescribedinthisInternationalStandardapplytospecifictypesofankle-disarticulationprostheses(seeNOTE3),totranstibial(below-knee),knee-disarticulationandtransfemoral(above-knee)prosthesesandtothedistal(lower)partofhip-disarticulationandhemi-pelvectomyprostheses(seeNOTE4).NOTE1ISO22523(formerlyEN12523)addressesthoseoftheEssentialRequirementslistedinAnnex1oftheEuropeanMedicalDeviceDirective93/42/EECthatareapplicabletoexternallimbprosthesesandexternalorthoses.NOTE2Thetestscanbeperformedoncompletestructures,onpartstructuresoronindividualcomponents.NOTE3Thetestsonlyapplytoankle-disarticulationprostheseswhichinclude(foot)componentsofprostheticankle-footdevicestakenfromthenormalproductionline.NOTE4Thedistalpartcomprisesthekneeunit,theankle-footdeviceandallpartsbetween.TestsonhipunitsaredescribedinISO15032.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:150P.;A4
【正文语种】:英语