DIN EN ISO 22675-2007 假肢.脚踝装置和脚部件试验.要求和试验法
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【英文标准名称】:Prosthetics-Testingofankle-footdevicesandfootunits-Requirementsandtestmethods(ISO22675:2006);EnglishversionofDINENISO22675:2007-04
【原文标准名称】:假肢.脚踝装置和脚部件试验.要求和试验法
【标准号】:DINENISO22675-2007
【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】:
【英文主题词】:
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityofprostheticankle-footdevicesandfootunitswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtothisInternationalStandard.WARNING—ThisInternationalStandardisnotsuitabletoserveasaguidefortheselectionofaspecificankle-footdeviceorfootunitintheprescriptionofanindividuallowerlimbprosthesis!Anydisregardofthiswarningcanresultinasafetyriskforamputees.ThisInternationalStandardprimarilyspecifiesacyclictestprocedureforankle-footdevicesandfootunitsofexternallowerlimbprostheses,distinguishedbythepotentialtorealisticallysimulatethoseloadingconditionsofthecompletestancephaseofwalkingfromheelstriketotoe-offthatarerelevanttotheverificationofperformancerequirementssuchasstrength,durabilityandservicelife.Thispotentialisofparticularimportancefortheassessmentoftheperformanceofavarietyofrecentdesignsofankle-footdevicesandfootunitswithspecificcharacteristicsthatwillonlydevelopunderrealisticconditionsofloading.Inaddition,thisInternationalStandardspecifiesastatictestprocedureforprostheticankle-footdevicesandfootunits,consistingofastaticprooftestandastaticultimatestrengthtest,distinguished,besidesotherfeatures,(seeNOTE2)bythepotentialtogenerateheelandforefootforcesatlinesofactionconformingtothoseoccurringattheinstantsofmaximumheelandforefootloadingduringthecyclictest.Theloadingconditionsaddressedinthethirdparagrapharecharacterizedbyaloadingprofiledeterminedbytheresultantvectoroftheverticalandhorizontal(A-P)groundreactionforcesandbyalocomotionprofiledeterminedbythetibiaangle.ThetestloadingconditionsspecifiedinthisInternationalStandardarecharacterizedbystandardizedformatsoftheseloadingandlocomotionprofiles,tobeuniformlyappliedbythecyclicandstatictestprocedurestoeachsampleofankle-footdeviceorfootunitsubmittedfortest.AccordingtotheconceptofthetestsofthisInternationalStandard,eachsampleofankle-footdeviceorfootunitsubmittedfortestis,nevertheless,freetodevelopitsindividualperformanceunderload.NOTE1ISO22523(formerlyEN12523)addressesthoseoftheEssentialRequirementslistedinAnnexIoftheEuropeanMedicalDeviceDirective93/42/EECthatareapplicabletoexternallimbprosthesesandexternalorthoses.NOTE2ThelinesofactionoftheheelandforefootforcesgeneratedbythestatictestprocedurespecifiedinthisInternationalStandardapproachthosedeterminingthesagittalplaneloadingofthetestloadingconditionsIandIIfortheprincipalstructuraltestsspecifiedinISO10328,withoutchangingthevaluesoftheanglesoftheheelandforefootplatform(s)forthestructuraltestsonankle-footdevicesandfootunitsspecifiedinISO10328.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:104P.;A4
【正文语种】:英语
【原文标准名称】:假肢.脚踝装置和脚部件试验.要求和试验法
【标准号】:DINENISO22675-2007
【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】:
【英文主题词】:
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityofprostheticankle-footdevicesandfootunitswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtothisInternationalStandard.WARNING—ThisInternationalStandardisnotsuitabletoserveasaguidefortheselectionofaspecificankle-footdeviceorfootunitintheprescriptionofanindividuallowerlimbprosthesis!Anydisregardofthiswarningcanresultinasafetyriskforamputees.ThisInternationalStandardprimarilyspecifiesacyclictestprocedureforankle-footdevicesandfootunitsofexternallowerlimbprostheses,distinguishedbythepotentialtorealisticallysimulatethoseloadingconditionsofthecompletestancephaseofwalkingfromheelstriketotoe-offthatarerelevanttotheverificationofperformancerequirementssuchasstrength,durabilityandservicelife.Thispotentialisofparticularimportancefortheassessmentoftheperformanceofavarietyofrecentdesignsofankle-footdevicesandfootunitswithspecificcharacteristicsthatwillonlydevelopunderrealisticconditionsofloading.Inaddition,thisInternationalStandardspecifiesastatictestprocedureforprostheticankle-footdevicesandfootunits,consistingofastaticprooftestandastaticultimatestrengthtest,distinguished,besidesotherfeatures,(seeNOTE2)bythepotentialtogenerateheelandforefootforcesatlinesofactionconformingtothoseoccurringattheinstantsofmaximumheelandforefootloadingduringthecyclictest.Theloadingconditionsaddressedinthethirdparagrapharecharacterizedbyaloadingprofiledeterminedbytheresultantvectoroftheverticalandhorizontal(A-P)groundreactionforcesandbyalocomotionprofiledeterminedbythetibiaangle.ThetestloadingconditionsspecifiedinthisInternationalStandardarecharacterizedbystandardizedformatsoftheseloadingandlocomotionprofiles,tobeuniformlyappliedbythecyclicandstatictestprocedurestoeachsampleofankle-footdeviceorfootunitsubmittedfortest.AccordingtotheconceptofthetestsofthisInternationalStandard,eachsampleofankle-footdeviceorfootunitsubmittedfortestis,nevertheless,freetodevelopitsindividualperformanceunderload.NOTE1ISO22523(formerlyEN12523)addressesthoseoftheEssentialRequirementslistedinAnnexIoftheEuropeanMedicalDeviceDirective93/42/EECthatareapplicabletoexternallimbprosthesesandexternalorthoses.NOTE2ThelinesofactionoftheheelandforefootforcesgeneratedbythestatictestprocedurespecifiedinthisInternationalStandardapproachthosedeterminingthesagittalplaneloadingofthetestloadingconditionsIandIIfortheprincipalstructuraltestsspecifiedinISO10328,withoutchangingthevaluesoftheanglesoftheheelandforefootplatform(s)forthestructuraltestsonankle-footdevicesandfootunitsspecifiedinISO10328.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:104P.;A4
【正文语种】:英语
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