1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 14879-1:2000 ICS 1
2、1.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial traysThis British Standard, having been prepared under the direction of the Health and Environment Sector Comm
3、ittee, was published under the authority of the Standards Committee and comes into effect on 15 July 2000 BSI 07-2000 ISBN 0 580 36150 0 BS ISO 14879-1:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard reproduces verbatim ISO 14879-1:2000 and imp
4、lements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/25, Orthopaedic joint prostheses, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries o
5、n the interpretation, or proposals for change, and keep the UK interests 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 St
6、andards which implement international or European publications referred to in this document 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 Stan
7、dard does not purport to include all the necessary provisions of a contract. Users of 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,
8、 an inside front cover, the ISO title page, pages ii to iv, pages 1 to 7 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.Referencenumber ISO14879-1:2000(E) INTERNATIONAL STANDARD ISO 14879-1 Firstedition 2000-06-01 ImplantsforsurgeryT
9、otalknee-joint prostheses Part1: Determinationofendurancepropertiesof kneetibialtrays Implants chirurgicaux Prothses totales de larticulation du genou Partie 1: Dtermination des proprits dendurance des tablettes tibiales du genouISO14879-1:2000(E) ii ISO14879-1:2000(E)iii Contents Page Foreword.iv 1
10、 Scope1 2 Normativereferences1 3 Termsanddefinitions.1 4 Principle2 5 Apparatus.2 6 Procedure.3 7 Testreport4 8 Disposaloftestspecimens4 Bibliography7ISO14879-1:2000(E) iv Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).Th
11、eworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,in liaisonwithISO,alsotakepart
12、inthework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtotheme
13、mberbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. AttentionisdrawntothepossibilitythatsomeoftheelementsofthispartofISO14879maybethesubjectof patentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. Internationa
14、lStandardISO14879-1waspreparedbyTechnicalCommitteeISO/TC150, Implants for surgery, SubcommitteeSC4, Bone and joint replacements. ISO14879consistsofthefollowingpart,underthegeneraltitle Implants for surgery Total knee-joint prostheses: Part 1: Determination of endurance properties of knee tibial tray
15、sINTERNATIONALSTANDARD ISO14879-1:2000(E)1 ImplantsforsurgeryTotalknee-jointprostheses Part1: Determinationofendurancepropertiesofkneetibialtrays 1 Scope ThispartofISO14879specifiesatestmethodfordeterminingtheenduranceproperties,underspecifiedlaboratory conditions,oftibialtraysusedinknee-jointprosth
16、esestosupportandsecuretheplasticsarticulatingsurface.It appliestotibialtrayswhichcoverboththemedialandlateralplateauxofthetibia. Thetestmethoddoesnotapplytotibialcomponentsmanufacturedsolelyfromplasticsmaterials. ThispartofISO14879doesnotcovermethodsofexaminingandreportingthefinalconditionofthetests
17、pecimen; thesemaybethesubjectofagreementbetweenthetestlaboratoryandthepartiessubmittingthespecimenfor test. 2 Normativereferences Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsof thispartofISO14879.Fordatedreferences,subsequentamendmentsto,orrevi
18、sionsof,anyofthesepublications donotapply.However,partiestoagreementsbasedonthispartofISO14879areencouragedtoinvestigatethe possibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundated references,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIEC
19、maintain registersofcurrentlyvalidInternationalStandards. ISO4965:1979, Axial load fatigue testing machines Dynamic force calibration Strain gauge technique. ISO7207-1:1994, Implants for surgery Components for partial and total knee-joint prostheses Part 1: Classification, definitions and designatio
20、n of dimensions. 3 Termsanddefinitions ForthepurposesofthispartofISO14879,thetermsanddefinitionsgiveninISO7207-1apply,togetherwiththe following. 3.1 anteroposteriorcentreline linewhichpassesthroughthecentreofthetibialtray,paralleltothesagittal 3.3 mediolateralcentreline linewhichpassesthroughthecent
21、reofthetibialtray,paralleltothecoronal,orfrontal,planeISO14879-1:2000(E) 2 3.4 momentarm d ml perpendiculardistancebetweentheanteroposteriorcentrelineofthetibialcomponentandtheaxisofload application NOTE Thedistanceispositiveiftheloadingpointisposteriortothecentreline. 3.5 momentarm d ap perpendicul
22、ardistancebetweenthemediolateralcentrelineofthetibialcomponentandtheaxisofloadapplication 4Principle Thetestspecimenisplacedinatestrigandfixedsothatonecondyleofthetrayextendsasacantilever.Acyclic loadisappliedtotheunsupportedcondylethroughanultra-highmolecularweightpolyethylene(PE-UHMW) spacer.Thecy
23、clicloadisapplieduntilthetestspecimenexhibitsfailureoruntilthechosennumberofcycleshas beenattained.Thespecimenisexaminedfordefectscausedbytheloading. 5 Apparatus 5.1 Testingmachine,withthefollowingcharacteristics: a) asinusodialdynamic-loadingwaveformor,ifnotsinusoidal,asmoothwaveformwithnoovershoot
24、s; b) anerrorinappliedloadnotgreaterthan 2%atthemaximumload(inaccordancewithISO4965); c) instrumentationtomaintainthevaluesofthemaximumandminimumloadsonthetibialtraytestspecimento anaccuracyof 2%,andtostopthetestiftheseloadsdifferfromtheirspecifiedvaluesbymorethan 2%; d) instrumentationtorecordthenu
25、mberofcycles. 5.2 Meansoffixingthetestspecimen,toallow: a) thetestspecimentobeheldasacantileverbeam; b) fixingtheinferiorsurfaceorclampingthesuperiorsurfaceoftheunsupportedtestspecimentrayawayfromthe mid-line; NOTE Epoxyresinorbonecement(seeforinformationISO5833)maybeusedasanembeddingmaterial. c) th
26、etibialtraytobesupporteduptothecentreline(seeFigures1and2).Ifthetrayincludesacentralstemor otherprominenceontheinferiorsurface,theseshallbesupportedinthesamemanner. d) theloadaxistobeperpendiculartotheundeflectedsuperiorsurfaceofthetestspecimen. 5.3 Ultra-highmolecularweightpolyethylenespacer,tobepl
27、acedbetweenthetestspecimenandtheload applicatortodistributetheloadingandreducefretting. Thespacershallhaveadiameterof13mm 0,5mmandathicknessattherimof6mm 0,5mm.Thespacer diameterand/orshapemaybemodifiedtoaccommodatethetibialtraydesignbeingtested,butanydeviations fromthesespecifieddimensionsshallbein
28、cludedinthetestreport. NOTE Materialinaccordancewithgrade1orgrade2ofISO5834-2hasbeenfoundsuitable.ISO14879-1:2000(E)3 5.4 Loadapplicator,arodofdiameter32mm 1mmwithasphericalindentorend. Itisrecommendedthattheindentorbemanufacturedfromasteelorcobalt-chromealloy. NOTE Theloadapplicatormaybemodifiedtoa
29、ccommodateaspectsofthetraydesign,suchasarimaroundthe periphery. 6 Procedure 6.1 DeterminetheoverallmediolateralandanteroposteriordimensionsinaccordancewithISO7207-1:1994, Figures2and3. 6.2 Fixthetestspecimeninthetestriginaccordancewith5.2c).Ifthetestspecimenisasymmetrical,ensure thatitisfixedsothatt
30、hebendingmomentisamaximumatthejunctionofthetraywiththestem,oratthedivision betweenthemedialandlateralcompartmentsifnostemispresent.Ensurethatthereisaclearanceofatleast 5mmbetweentheundersurfaceoftheloadedcompartmentonthetibialtrayandanypartofthefixture.Ensure thattheloadedpartofthetibialtraydoesnotm
31、akecontactwithanypartofthefixtureduringtesting. 6.3 Positionthetestspecimensothattheloadaxisisperpendiculartotheundeflectedsuperiorsurfaceofthe tray. NOTE1 Thetraysurfacewillnotremainperpendiculartotheloadaxisduringloading. NOTE2 Theloadingpointwillbelocatedatadistanced mlfromtheanteroposteriorandd
32、apfromthemediolateralcentrelinein thepositionwhereitisexpectedtobeloaded in vivo at 0 o flexion. 6.4 Useoneofthefollowingmethodstodeterminethepositionoftheloadingpoint. a) Forbiconcavetibialdesigns,theloadingpointshallbeattheintersectionwiththetrayofalinedrawnnormal tothetraywhichintersectsthedeepes
33、tpartoftherecessinthearticularsurface. b) Forothertibialcomponents,thefemoralcomponent,thetibialarticulatingsurfacecomponentandthetibial trayshallbeassembledat0 o flexionandthepositionofthecentreofpressuredetermined.Thecentreof pressureshallbeonthelineperpendiculartothetraywhichpassesthroughtheloadi
34、ngpoint. NOTE Thepositionofthecentreofpressuremaybedeterminedusingpressure-sensitivefilm,removabledye,a3-DCAD systemorcomponentdrawings. 6.5 Measurethedimensionsd ap andd ml (3.4,3.5andFigure1). 6.6 Placethespacer(5.3)betweenthetestspecimenandtheloadapplicator(Figure1or2). Thespacershouldbereplacedi
35、f,duringtesting,itsthicknessisreducedto3mmorifitfragments. NOTE Thespacermaybefixedtothetrayusingepoxyresincement. 6.7 Withthesphericalindentorinplace,startthetestingmachineandadjustitsothatitappliesthemaximum loadF max ,usingaminimumloadtomaximumloadratioof10,atafrequencynotgreaterthan10Hz.Thevalue
36、of F max shallbestatedbythepartysubmittingthespecimenfortest.Visuallyinspectthetrayundernormalor correctedvisionevery5 10 5 cycles(see6.8)withoutremovingthetrayfromthetestingmachine. 6.8 Continuethetestuntiloneofthefollowingoccurs: a) thespacerthicknessisreducedto3mmoritfragments; Inthiscasenotetheo
37、ccurrenceandfitanewspacerbeforecontinuingthetest; b) thetrayfractures;ISO14879-1:2000(E) 4 c) cracksareobservedwhenthetrayisinspectedundernormalorcorrectedvision; d) 5 10 6 cyclestestdurationisachieved; e) thetestmachinefailstomaintainthespecifiedloadrange5.1b). 6.9 Attheendofthetest: a) recordtheto
38、talnumberofcyclesofloadingappliedwhenthetestwasterminated; b) reportthereasonforterminationofthetest; c) examinethetestspecimensusingthemethodsrequestedbythepartythatsubmittedthespecimenfortesting. 7 Testreport Thetestreportshallincludethefollowinginformation: a) areferencetothispartofISO14879; b) t
39、heidentityofthetestspecimens,asstatedbythepartysubmittingthespecimenfortest,includingtibialtray thickness,size,dandwasdefinedinISO7207-1,andmaterialsofconstruction; c) detailsofthetestconditions,includingspacerdiameterandthickness(includinganydeviationsindiameteror shape),d ml ,d ap ,fixationmethod,
40、frequency,andmaximumload; d) whetheroneormorereplacementspacerswasused; e) astatementofresultsincludingnumberofcyclesappliedandlocationoffracture(iffractured),descriptionof testspecimensattheendofthetest,andtheresultsofexaminationrequestedbythepartysubmittingthe specimenfortest. 8 Disposaloftestspec
41、imens Testprosthesesshallnotbeusedforclinicalpurposesaftertesting.Careshouldbeexercisedintheuseofthe specimensforfurthermechanicaltests,becausetheloadingregimemayhavealteredthemechanicalproperties.ISO14879-1:2000(E)5 Dimensionsinmillimetres Key 1 Anteroposteriorcentreline 2 Pointofloadapplication 3
42、Mediolateralcentreline 4 Loadapplicator 5 Fixation(awayfromthecentrelineand/orontheinferior surface) 6 Tibialtray 7 Spacer Figure1Schematicdiagramoftestset-upfortibialtrayswithoutcentralstem(anteriorview)ISO14879-1:2000(E) 6 Dimensionsinmillimetres Key 1 Anteroposteriorcentreline 2 Pointofloadapplic
43、ation 3 Mediolateralcentreline 4 Loadapplicator 5 Fixation(awayfromthecentrelineand/orontheinferior surface) 6 Tibialtray 7 Spacer Figure2Schematicdiagramoftestset-upfortibialtrayswithcentralstem(anteriorview)ISO14879-1:2000(E)7 Bibliography 1 ISO5833, Implants for surgery Acrylic resin cements. 2 I
44、SO5834-2, Implants for surgery Ultra-high molecular weight polyethylene Part 2: Moulded forms.BS ISO 14879-1:2000 BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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