1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 15032:2000 ICS 11.
2、040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Prostheses Structural testing of hip jointsThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and co
3、mes into effect on 15 June 2000 BSI 06-2000 ISBN 0 580 34965 9 BS ISO 15032:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard reproduces verbatim ISO 15032:2000 and implements it as the UK national standard. The UK participation in its preparatio
4、n was entrusted to Technical Committee CH/9, Orthotics and external prosthetics, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests
5、informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this do
6、cument may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of
7、 British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 3
8、8, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.Referencenumber ISO15032:2000(E) INTERNATIONAL STANDARD ISO 15032 Firstedition 2000-04-15 ProsthesesStructuraltestingofhipunits Prothses Essais portant sur la str
9、ucture des prothses de hancheISO15032:2000(E) ii ISO15032:2000(E)iii Contents Page Foreword.iv Introduction.v 1 Scope1 2 Normativereference1 3 Termsanddefinitions.1 4 Testconfigurations.2 4.1 General2 4.2 Axesofcoordinatesystem.2 4.3 Referenceplanes.2 4.4 Referencepoints5 4.5 Testforce5 4.6 Loadline
10、.5 4.7 Referencedistances5 5 Testsamples5 5.1 Typesoftestsample.5 5.2 Responsibilitiesregardingselection,preparationandalignmentoftestsamples6 5.3 Selectionoftestsamples6 5.4 Preparationoftestsamples6 5.5 Alignmentoftestsamples7 6 Testrequirementsandconditions.8 6.1 Typesoftest.8 6.2 Testloadingrequ
11、irements8 6.3 Requirementsandconditionsrelevanttotestproceduresandequipment9 6.4 A-PandM-Ltestprocedures12 6.5 Torsionaltestprocedures.18 6.6 Numberoftestsrequired23 6.7 Restrictionsonmultipleuseoftestsamples.23 6.8 Accuracy.23 7 Testloadingparameters.24 7.1 Testloadsandreferences24 7.2 Detailsofloa
12、ding.25 8 Testsubmissiondocument27 8.1 Documentneed27 8.2 Generalrequirements27 8.3 Informationrequiredfortestsamples.28 8.4 Informationrequiredfortests28 9 Testreport29 9.1 Generalrequirements29 9.2 Recordsrequiredforalltestsamples.29 9.3 Recordsrequiredforalltests.30 9.4 Recordsrequiredforresultso
13、fA-PandM-Ltests30 9.5 Recordsrequiredforresultsoftorsionaltests31 AnnexA(normative)Descriptionofinternalloadsandtheireffects32 AnnexB(informative)ReferencedataforthespecificationoftheA-P,M-Landtorsionaltestloading conditionsatdifferenttestloadinglevels.35 Bibliography38ISO15032:2000(E) iv Foreword I
14、SO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therightto
15、berepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththe
16、rulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInterna
17、tionalStandardmaybethesubjectof patentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardISO15032waspreparedbyTechnicalCommitteeISO/TC168, Prosthetics and orthotics. AnnexAformsanintegralpartofthisInternationalStandard.AnnexBisgivenforinformationonly.ISO1
18、5032:2000(E)v Introduction ThroughoutthisInternationalStandard,thetermprosthesismeansanexternallyapplieddeviceusedtoreplace wholly,orinpart,anabsentordeficientlimbsegment. Duringuseaprosthesisissubjecttoaseriesofloadactionseachvaryingindividuallywithtime.Thetestmethods specifiedinthisInternationalSt
19、andardusesimplifiedstaticandcyclicstrengthtestsinwhichantero-posterior(A-P) andmedio-lateral(M-L)componentsofloadingareproducedinseparatetestsbytheapplicationoftestforcesin twodifferenttestplanes. Thestatictestsrelatetotheworstloadsgeneratedinanyactivity.Thecyclictestsrelatetonormalwalkingactivities
20、 whereloadsoccurregularlywitheachstep.ThisInternationalStandardspecifiesfatiguetestingofstructural components.Thetestsspecifieddonotprovidesufficientdatatopredictactualservicelife. Theevaluationofhipdisarticulationprosthesesandtheircomponentsrequirescontrolledfieldtrialsinadditionto thelaboratorytes
21、tsspecifiedinthisInternationalStandard. Thelaboratorytestsandfieldtrialsshouldberepeatedwhensignificantdesignchangesaremadetoaload- bearingpartofaprosthesis. Ideally,additionallaboratorytestsshouldbecarriedouttodealwithfunction,wearandtear,newmaterial developments,environmentalinfluences,andamputeea
22、ctivitiesaspartoftheevaluationprocedure.Thereareno standardsforsuchtests,soappropriateprocedureswillneedtobespecified.INTERNATIONALSTANDARD ISO15032:2000(E)1 ProsthesesStructuraltestingofhipunits 1 Scope ThisInternationalStandardspecifiestestmethodsforcomponentsandassembliesofhipdisarticulationprost
23、heses whicharearrangedathipandthighlevel.Itdoesnotapplytoothercomponentsoflowerlimbprosthesesforwhich testmethodsaregiveninISO10328. ThisInternationalStandardspecifiesproceduresforsimplifiedstaticandcyclicstrengthtestsinwhichtheantero- posterior(A-P)andmedio-lateral(M-L)componentsofloadingareproduce
24、dinseparatetestsbytheapplicationof testforcesintwodifferenttestplanes.Thecomponentsofloadingproducedinthetestsamplerelatetothepeak valuesofthecomponentsofloadingwhichnormallyoccuratdifferentinstantsduringthestancephaseofwalking. 2 Normativereference Thefollowingnormativedocumentcontainsprovisionswhi
25、ch,throughreferenceinthistext,constituteprovisionsof thisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthese publicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedto investigatethepossibilityofapplyingthemostrecenteditiono
26、fthenormativedocumentindicatedbelow.For undatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIEC maintainregistersofcurrentlyvalidInternationalStandards. ISO8549-1:1989, Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and ex
27、ternal orthoses. 3 Termsanddefinitions ForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO8549-1andthefollowing apply. 3.1 brittlefailure fractureofanycomponentwithoutsignificantplasticdeformationatthefracture 3.2 ductilefailure . fractureofanycomponentwithsignificantplasticde
28、formationatthefracture 3.3 ductilefailure . grossplasticdeformationofthetestsample 3.4 testequipment anytestmachineordeviceadaptedorspecificallydesignedtothetestrequirementsofthisInternationalStandard andcomplyingwiththerequirementsonaccuracyof6.8ISO15032:2000(E) 2 4 Testconfigurations 4.1 General 4
29、.1.1 Foreaseininterpretation,presentationandapplicationofthisInternationalStandard,twotest configurationsarespecified,oneforright-sidedapplicationandamirrorimageforleft-sidedapplication.This approachenablestheapplicationofuniformsignconventionsforcorrespondingcomponentsofloadinggenerated intheload-b
30、earingstructuresofrightandleftprosthesesorasymmetricallydesignedprostheticcomponents. 4.1.2 Eachtestconfigurationisdefinedinathree-dimensional,rectangularcoordinatesystem,containinga geometricsystemofplanes,linesandpoints(seeFigures1and2). 4.1.3 Eachtestconfigurationspecifiesreferenceparametersbothf
31、orthepositionofthelineofapplicationofthe testforceandforthealignmentoftestsampleswithinthecoordinatesystem. 4.2 Axesofcoordinatesystem 4.2.1 Theaxesofeachofthecoordinatesystemshaveanoriginatgroundlevelandarespecifiedin4.2.2to 4.2.4inrelationtoaprosthesiswhichisstandingonthegroundinaverticalposition.
32、 Ifatestsampleisnotinaverticalposition,theaxesofthecoordinatesystemshallberotatedtocorrespond. 4.2.2 Theu -axisisalineextendingfromtheoriginandpassingthroughtheeffectiveknee-jointcentre(see 5.5.2.2)andtheeffectivehip-jointcentre(see5.5.2.4).Itspositivedirectionisupwards(intheproximaldirection). 4.2.
33、3 Theo -axisisperpendiculartotheu -axisandparalleltotheeffectivehip-jointcentreline(see5.5.2.3).Its positivedirectionisoutward(inthelateraldirection),whichistotheleftforaleftprosthesisandtotherightfora rightprosthesis. 4.2.4 Thef -axisisperpendiculartoboththeo -axisandtheu -axis.Itspositivedirection
34、isforwardtowardsthe toe(intheanteriordirection). 4.3 Referenceplanes Thereferenceplanes(seeFigure1)shallbeparallelplanesperpendiculartotheu -axisofthecoordinatesystem. 4.3.1 Bottomreferenceplane,BK Thebottomreferenceplane,BK,islocatedatadistanceu=u BK fromtheorigin.Itcontainsthebottomload applicatio
35、npointP BK . 4.3.2 Kneereferenceplane,K Thekneereferenceplane,K,islocatedatadistanceu=u K fromtheorigin.Itcontainstheeffectiveknee-joint centre(see5.5.2.2). 4.3.3 Hipreferenceplane,H Thehipreferenceplane,H,islocatedatadistanceu=u H fromtheorigin.Itcontainstheeffectivehip-jointcentre (see5.5.2.4). 4.
36、3.4 Topreferenceplane,TH Thetopreferenceplane,TH,islocatedatadistanceu=u TH fromtheorigin.Itcontainsthetoploadapplication pointP TH .ISO15032:2000(E)3 Key 1 Topreferenceplane,TH 2 Hipreferenceplane,H 3 Kneereferenceplane,K 4 Bottomreferenceplane,BK a Right b Left Figure1Coordinatesystemaccordingto4.
37、2withreferenceplanesISO15032:2000(E) 4 )A-Pext.testloadingcondition b)A-Pflex.testloadingcondition Key 1 Effectiveleverarm,L H 2 Effectivehipjointcentre 3 Effectivekneejointcentre 4 Effectiveleverarm 5 Effectivehipjointcentreline 6 Effectivekneejointcentreline 7 Effectivehipjointcentre 8 Effectivekn
38、eejointcentre c)M-Ltestloadingcondition Figure2TestconfigurationsforA-PandM-Ltestsinf -u-ando -u-planeISO15032:2000(E)5 4.4 Referencepoints Thereferencepointsshallbethepointsofintersectionoftheloadline(see4.6)withthereferenceplanes.The coordinatesofthereferencepointsareasfollows: bottomloadapplicati
39、onpointP BK (f BK ,o BK ,u BK ); kneeloadreferencepointP K (f K ,o K ,u K ); hiploadreferencepointP H (f H ,o H ,u H ); toploadapplicationpointP TH (f TH ,o TH ,u TH ). NOTE Inthefollowingtextthef-ando -coordinatesarealsoreferredtoasoffsets(seealso4.7). 4.5 Testforce ThetestforceFshallbeasinglecompr
40、essiveloadappliedtothebottomandtoploadapplicationpointsP BK and P TH . 4.6 Loadline TheloadlineshallbethelineofapplicationofthetestforceFwhichpassesthroughthereferencepointsP K and P H . 4.7 Referencedistances 4.7.1 Offsets Theoffsetsshallbetheperpendiculardistancesofthereferencepoints(see4.3.1and4.
41、4)fromtheo-u-planeand theu-f-planeofthecoordinatesystems(see4.1and4.2).Theyareidenticalwiththecorrespondingf-oro - coordinates,respectively,ofthesereferencepoints. 4.7.2 Effectiveleverarms Theeffectiveleverarmsshallbetheperpendiculardistancesfromtheloadlinetotheeffectivejointcentres(see 5.5.2.2and5.
42、5.2.4),whereL K representsthekneeeffectiveleverarmandL H thehipeffectiveleverarm. 4.7.3 DistanceL BK-TH L BK-TH shallbethedistancebetweenthebottomloadapplicationpointP BK (see4.3.1and4.4)andthetopload applicationpointP TH (see4.3.4and4.4). 5 Testsamples 5.1 Typesoftestsample 5.1.1 Numberoftypes Ther
43、earetwotypesoftestsample,asdescribedin5.1.2and5.1.3.ISO15032:2000(E) 6 5.1.2 Completestructure Thecompletestructureshallcomprisethehipunitandatleastthefollowing: a) thighsegmentorsuitableattachment; b) anyspecialattachmentattheknee;and/or c) anypartsabovethehipunitincludingthesocket. 5.1.3 Hipunit T
44、hehipunitshallbeattachedtosuitableattachmentstogivethesameoveralldimensionsasthecomplete structure. Theinterfaceofsuchattachmentsshallhavemechanicalcharacteristicssimilartothoseoftheintendedadjacent components. 5.2 Responsibilitiesregardingselection,preparationandalignmentoftestsamples 5.2.1 Themanu
45、facturer/submittershallberesponsiblefortheselectionandassemblyofthecomponentstobe tested,andfortheprovisionofspecifiedpartstobereplacedduringthecyclictests. 5.2.2 Themanufacturer/submittershallberesponsibleforpreparingthetestsubmissiondocumentcompletewith alignmentand/orserviceinstructions,asnecessa
46、ry. 5.2.3 Themanufacturer/submittershallapplyauniqueandtraceableidentificationtoeachtestsample. 5.2.4 Theloadapplicationlevers(see6.2.1)shallbeattachedbyeitherthemanufacturer/submitterorthetest laboratory/facility. 5.2.5 Thetestlaboratory/facilityshallseektheadviceofthemanufacturer/submitterifthespe
47、cificdesignofhip unitsincorporatesanyspecialcharacteristics. 5.2.6 Thetestlaboratory/facilityshallberesponsibleforadjustmentofthealignmenttogivethecorrectoffsets andeffectiveleverarmsduringtest. 5.3 Selectionoftestsamples Ifappropriate,theprostheticstructuresselectedfortestshallbedrawnfromstandardpr
48、oduction.Detailsofthe selectionshallberecordedinthetestsubmissiondocument.Ifthemanufacturer/submittersuppliesacertificate statingthatthetestsamplehasbeentakenfromthenormalproduction,thiscertificateshallbeincludedinthetest submissiondocument,togetherwithdetailsofthesamplingmethod. 5.4 Preparationofte
49、stsamples Anycosmeticcomponentsshallbeomittedfromthetestsample,unlesstheycontributetothestructuralstrength. Thetestsamplesshallincludeallpartsnormallyfitted. NOTE Duringthecourseofthecyclictests,specifiedpartsarereplacedwhenthenumberofcycleshasreachedavalueat whichsuchreplacementisindicatedinaccordancewiththemanufacturers/submittersserviceinstructionsand/orthetest submissiondocument. Thetestsampleincludinganyendfittingsshallbeassembledinaccordancewiththeresponsibilitiesregardingthe preparationofthetestsampleandthetestsubmissiond
