ISO TS 04549-2023.docx

ISO/TS4549TECHNICA1.SPECIFICATIONeditionFirst2O23-O7OrthoticsMethodfortestingthere1.iabi1.ityofmicroprocessor-contro1.1.edank1.emomentunitsofank1.e-footorthoses©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.orkwqntto<itH0Dtf1.e!ron>ctu1.aicnpkni1tUqntt*>HdU>cop)nppU1.>joationmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountr)oftherequester.f),WV>fifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.227490111觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForeword.IntroductionCSconeV1IVZ3Normativereferences1Termsanddefinitions145DesignationsandSyinboIS_2Requirements35.1Genera1.35.2DefinitionofTestparameters5.2.2Cesk?ivikhoutintegratedcensors35.2.3Examp1.eofasetoftest1.eve1.s465.3Testpreparation4Sekiipconditions56.1Genera1.56.2Coordinatesystem56.i1.ogcttngiofvthe1.egdummy56.5Essentia1.Drooertiesoforthosestotest66.6Vertica1.1.oadingoftheOrthoses67Testprocedure87.1Statictestfornwtionresistanceoftheank1.ejointdummy8Q7.2Cvc1.ictest9OTestreport999.1Comp1.iancetomotionresistanceoftheank1.ejointdummy.109.2Conip1.idncctoCydiCtest109.391H(tiiprGntif*ra1.(fo1111ritnc11AnnexA(informative)Measurementsystemfortheacquisitionof1.oaddataofanorthosisfortheIoWCrIimbS12Bibhograph)15OrthoticsMethodfortestingthere1.iabi1.ityofmicroprocessor-contro1.1.edank1.emomentunitsofank1.efootorthoses1 Scopeunitsofank1.e-footorthosis,movinginp1.antar-anddorsif1.exiondirection.comp1.ianceank1.edocumentunits.Ithowcomp1.ianceisdocumentedoutcomeIFU.thetesta1.1.owstoc1.aimmotion.inGeometrica1.Constrainstestsinstead,wheremotionisstoppedinsteadofsustainingit,canbeunitsisdescribed.2 Normativereferencesconstitutesrequirements1.atestcditiondocument.referencedrefercnces,(inc1.udingamendments)app1.ies.app1.ies.methods3 TermsanddefinitionsISOandIECmaintaintennino1.ogydatabasesforuseinstandardizationatthefo1.1.owingaddresses：3.1 IECE1.ec1.ropcdia:avai1.ab1.eathUpwww.e1.esGped.Fmicroprocessor-contro1.1.edank1.emomentunitdorsif1.exionandp1.antarf1.exionDimensionsinmmKeyEUforceonprostheticdummyFoot1.engthforceon1.oaddistributionringFigure2Dummyprosthesisandorthosesintestrig7Testprocedure7.1 Statictestformotionresistanceoftheank1.ejointdummyThetestformotionresistanceoftheank1.ejointdummy,re1.atedtothemaximumtest1.eve1.softhetest,isperformedinthefo1.1.owingConseaRivesteps.a) The1.egdummyisa1.ignedintothetestapparatusaccordingto6.2ofthisdocument.b) Beforestartingthetestthe1.egdummyassemb1.yisun1.oaded.c) Thep1.ateang1.eoftheti1.ting-p1.ateissettoAng1.eFtc11i>x.d) The1.egdummyis1.oadedto10%ofFIEaXinaratebetween100N/sand10000Ns.e) The1.egdummyisun1.oadedand1.iftedthathigh,thatthe1.egdummyisnottouchingtheti1.tingp1.atewhenitturnstoAng1.enaTheti1.ting-p1.ateisturnedtoap1.ateang1.eofAng1.ectn三0The1.egdummyis1.oadedto10%ofF2cmaxinaratebetween100N/sand10000N/s.g) The1.egdummyisun1.oadedand1.iftedthathigh,thatthe1.egdummyisnottouchingtheti1.tingp1.atewhenitturnstoAng1.eFIEgh) Thesteps1.b)toHg)arerepeatedoncewithoutmanipu1.atingthe1.eg-dummy.i) The1.eg-dummyisun1.oaded.5) descriptionoftheresu1.tingforceprofi1.e(三)ofthecyc1.ictest;6) testedcyc1.enumberforeachgroupoftest1.eve1.s;7) S品WBxyfM1.5Bneq?IrA福MPf1.WfesmeJrtdank1.emomenttomeasureddataofequiva1.ent8) 1.owestadjustab1.emeasuredmax./min.ank1.emomentduringp1.antar-anddorsiexionmotion;9) highestadjustab1.emeasuredmax./min.ank1.emomentduringp1.antar-anddorsif1.exionmotion;10) Initia1.1.yadjustedmeasuredmax./min.ank1.emomentduringp1.antar-anddorsif1.exionmotion;11) measuredp1.antar-anddorsif1.exionank1.emomentduringmotionatthe1OOOthcyc1.e;12) fina1.measuredp1.antar-anddorsif1.exionank1.emomentduringmotionandthecyc1.enumberwhenmeasured;13) comp1.ianceresu1.tofthecyc1.ictest;14) comp1.ianceresu1.toftheinitia1.testof9.1;15) comp1.ianceresu1.tofthefina1.testof-4;16) intermediateeventswhenmax./min."momentmeasured"ofthe100Othtestcyc1.eisexceedby±20%Mmaxor±20%fmi11beforereachingthefina1.cyc1.enumber,andthemeasurestoregainsuitabi1.ity9Comp1.ianceofthe1.egdummyforthetest.9.1 Comp1.iancetomotionresistanceoftheank1.ejointdummyComp1.iancetothesufficient1.y1.owmotionresistanceank1.ejointdummyrequirementcanbemaiiwdfdfabottheitf1.也11印OMkditiMVaIuea1.brfhk1.f>N(fc谒b1.ytouctiwtoite<otvisib1.jtyMmeitoi1.bhdiiiftecHtingp1.ate,andinitsrepetition.9.2 Comp1.iancetocyc1.ictestComp1.iancetothecyc1.ictestcriteriaofthisdocumentcanbec1.aimed,ifthep1.antar11exionandb3f1.exfa236Wfe】Mofrthma制eofjrtWhrae6tsmh?CIyUhedtghMrfft(M)Otott1.evd05c1.e.notexceed±20%9.3 IdentifierofComp1.ianceOrthoses1.forwhichcomp1.ianceofthere1.iab1.yofmotionresistanceofmicroprocessor-contro1.1.edank1.eunttidEthaiteiatedstbherttWBiethodsirfdiEWKAiMmeht用ZwdpKwfcm力即defafiedWithditoti1.Mtfionontheintendeduseoftheorthosisrsupp1.iedbythemanufacturer/submitterwiththedevice.9.3.1 Genera1.formatThegenera1.formatisgiveninPigUrC3.ISO4549-1.I-Aa-Cc-Dd-PpFigure3-Examp1.eAnnexA(informative)Measurementsystemfortheacquisitionof1.oaddataofanorthosisforthe1.ower1.imbsiffa11tatrf(jHi由ti11n1.对mta11rusedsht11tbtohiw,S(Kig1.eutA)ICuEithyuceUkiftUniversity,Japan,in20ISandFigureA.1.Dataacquisitionsystemofthe1.oadandtheshankinc1.inationang1.eoftheorthosisforthe1.ower1.imbsY44bendmoment(Nm)Shearforce(N)compressiveforce(N)shankang1.e(o)ank1.eAPbendingmomentank1.eM1.bendingmoment/XPshearforceM1.shcarforcccompressiveforceshankang1.esKey魂Y1.Y2Y3Y4123456AP,MR.moment8 P.KZ,moment9 M1.KZ,momentM1.,MR,moment11 AP.FS.MR12 P.FS.KZM1.FS.KZ14 M1.FS,MR15 Fcomp.KZFcomp,MR17 ang1.e1.18 ang1.e2FigureA.2Examp1.eofthemeasureddataoftheank1.e-footorthosisduring1.eve1.wa1.kingBib1.iography1 99d007,CoPWM他SandorthoticsCategorizationanddescriptionofexterna1.orthoses12BProstheticsStructura1.testingofIower-IimbProStheSeSRequirementsandtest