【英文标准名称】:Prosthetics-Structuraltestingoflower-limbprostheses-Requirementsandtestmethods
【原文标准名称】:修复术.假腿的结构试验.要求和试验方法
【标准号】:ISO10328-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-10
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC168
【标准类型】:()
【标准水平】:()
【中文主题词】:残疾人辅助器具;中心;定义;测定;肢;纵轴;假腿;医学科学;检验荷载;修复装置;规范(验收);样品;材料强度;专门装备;测试装入程序;试验;试验条件
【英文主题词】:Aidsforthedisabled;Artificialfeet;Centres;Conformity;Coordinatesystems;Definitions;Determination;Finemechanics;Limbs;Longitudinalaxis;Lower-limb-protheses;Medicalsciences;Proofloading;Prostheticdevices;Specification(approval);Specimens;Strengthofmaterials;Strengthtests;Stress;Structure;Technicalaid;Testloading;Testing;Testingconditions;Testingdevices;Testingset-ups
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityoflowerlimbprostheticdevices/structureswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtoISO22675:2006.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)componentsofprostheticanklefootdevicestakenfromthenormalproductionline.NOTE4Thedistalpartcomprisesthekneeunit,theankle-footdeviceandallpartsbetween.TestsonhipunitsaredescribedinISO15032.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40;11_180_10
【页数】:136P;A4
【正文语种】:英语