BS ISO 23317 2025.docx

《BS ISO 23317 2025.docx》由会员分享，可在线阅读，更多相关《BS ISO 23317 2025.docx（25页珍藏版）》请在三一文库上搜索。

1、BSISO23317:2025ImplantsforsurgeryMaterialsSimulatedbodyfluid(SBF)preparationprocedureandtestmethodtodetectapatiteformationinSBFforinitialscreeningofbone-contactingimplantmaterialsbsi.NationalforewordThisBritishStandardistheUKimplementationofISO23317:2025.ItsupersedesBSISO23317:2014,whichiswithdrawn.

2、TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH150llMaterialsforsurgicalimplants.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitscommitteemanager.ContractualandlegalconsiderationsThispublicationhasbeenpreparedingoodfaith,howevernorepresentation,warranty,

3、assuranceorundertaking(expressorimplied)isorwillbemade,andnoresponsibilityorliabilityisorwillbeacceptedbyBSIinrelationtotheadequacy,accuracy,completenessorreasonablenessofthispublication.Allandanysuchresponsibilityandliabilityisexpresslydisclaimedtothefullextentpermittedbythelaw.Thispublicationispro

4、videdasis,andistobeusedattherecipientsownrisk.Therecipientisadvisedtoconsiderseekingprofessionalguidancewithrespecttoitsuseofthispublication.Thispublicationisnotintendedtoconstituteacontract.Usersareresponsibleforitscorrectapplication.TheBritishStandardsInstitution2025PublishedbyBSIStandardsLimited2

5、025ISBN9780539249705ICS11.040.40CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30June2025.Amendments/corrigendaissuedsincepublicationDateTextaffectedInternationalStandardISO23317Fourthed

6、ition2025-06ImplantsforsurgeryMaterialsSimulatedbodyfluid(SBF)preparationprocedureandtestmethodtodetectapatiteformationinSBFforinitialscreeningofbonecontactingimplantmaterialsImplantsChirurgicauxMateriauxModeoperatoiredepreparationdefluidecorporelsimule(FCS)etmethodedessaipourdetecterlaformationd,ap

7、atitedansIeFCSpourVetudepreliminairedemateriauxd,implantencontactavecVosReferencenumberISO23317:2025(en)COPYRIGHTPROTECTEDDOCUMENTISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans

8、electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Email:copyrig

9、htiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Apparatusandmaterials25 Testspecimen35.1 Testspecimenshapeanddimensions35.2 Testspecimenpreparation35.3 Testspecimencharacterization36 Simulatedbodyfluid46.1 Gen

10、eral46.2 ReagentsforSBF46.3 PreparationofSBF56.3.1 General56.3.2 Step156.3.3 Step256.3.4 Step356.3.5 Step466.3.6 Step566.3.7 Step666.3.8 Step766.3.9 Step866.3.10 Step966.3.11 Step1066.3.12 Step1166.4 EvaluationofSBF76.5 PreservationofSBF77 ProcedureoftheSBFtest78 Testreport10Annex A (informative)App

11、aratusforpreparingSBF.L2Annex B (informative)Preparationofreferenceglasses13Bibliography14ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommitt

12、ees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onal

13、lmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.Thisdocumentwasdraftedinaccordancewiththeedit

14、orialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisd

15、ocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.

16、Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorldTradeOrganization(WTO)princ

17、iplesintheTechnicalBarrierstoTrade(TBT工seeWWW.iso.org/iso/foreword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/TC150,Implantsorsurgery,SubcommitteeSC1,Materials.Thisfourtheditioncancelsandreplacesthethirdedition(ISO23317:20141whichhasbeeneditoriallyrevised.Themainchangesare: thetitle,Introduc

18、tionandscopehavebeenrevisedtoclarifythesignificanceandlimitationsoftheSBFtest; thetermsanddefinitionsclausehasbeenrearrangedandrevisedforbetterunderstanding; thelistofapparatusandmaterialshasbeenenrichedanddetailed; thetestspecimenpreparationhasbeenrevised,andtestspecimencharacterizationhasbeenadded

19、 thepreparationofSBFhasbeenrevisedanddescribedinmoredetail; adescriptionoftestspecimenswithlowerdensitythanSBFhasbeenadded; thearrangementofthetestspecimenintheSBFtesthasbeenrevisedandexplaineddependingonthespecimensshapeanddensity; thenecessityofvisualinspectionofSBFhasbeenadded; thesoakingperiodo

20、fsevendaysintheSBFtesthasbeenspecified; thecriteriaforjudgingthespecimensapatite-formingabilityintheSBFtesthavebeenclarified; thetestreporthasbeendetailedaccordingtotherevisedSBFtestprocedure; thebibliographyhasbeenrevisedandeachbibliographicalentryhasbeencitedattherelevantpointinthisdocument.Anyfee

21、dbackorquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/membnrs.htmLIntroductionThemechanismofactionofbone-contactingimplantmaterialsisbaseduponacomplexseriesofreactionsinthebodythatcanbeinfluencedbythesurfacepropertiesofthei

22、mplantmaterialincontactwithbone.Insomecasesonsyntheticbone-contactingimplantmaterialssuchasBioglasslCeraboneA-W,Ceravital-typeglass-ceramicandsinteredhydroxyapatiteBioglasslCeraboneA-W,Ceravital(g)-typeglass-ceramicandsinteredhydroxyapatiteareexamplesofsuitableproductsavailablecommercially.Thisinfor

23、mationisgivenfortheconvenienceofusersofthisdocumentanddoesnot(Ca10(PO4)6(OH)2),alayerofanavascular,non-cellularapatite-likemineralphaseisfoundontheimplantsurface,atthebone-implantinterface,andissaidtopromotethebone-bondingbehaviour.Ithasbeenshownthatinvivoapatiteformationcanbeinitiallymodelledinvitr

24、ousinganumberofdifferentaqueoussolutions,includinganacellularsimulatedbodyfluid(SBF)withinorganicionconcentrationsnearlyequaltothosefoundinhumanbloodPlaSnIa口上虺.TheapatiteformedinanSBFtestcanindicateifanimplantmaterialsphysicochemicalsurfacefeatureswarrantfurtherevaluationandtesting,includingcellcult

25、urestudiesandanimalstudies,todemonstratesafetyandefficacyoftheimplantmaterialHL5.SBFdescribedinthisdocumentishighlysupersaturatedwithrespecttoapatiteandseveralothercalciumphosphatesandissimilarinpHandinorganicionconcentrationstohumanbloodplasma.SBFcanretainitsmetastablestatewithoutinducingcalciumpho

26、sphateprecipitationforfourweeksundercertain,well-Controlledconditionsdescribedinthisdocument.SBFhasbeenshowntoproduceacrystallinecalciumphosphate(apatite-like)layerthatischemicallyandcrystallographicallysimilartobonemineral.Thus,SBFcanbeusedasatestsolutionforinitialscreeningoftheformationofcalciumph

27、osphateandapatite-likemineralatthesurfaceofasyntheticbone-contactingimplantmaterial.SinceSBFcanbepreparedeasilyfromultrapurewaterandordinarychemicalreagents(inorganicsaltsandabuffer),andtheproposedSBFtestisasimpleandlow-costmethodavailableinalmosteverylaboratory,SBFhasbeenusedworldwideoverthepastfew

28、decadestoevaluateinorganicchemicalreactionsattheimplantsurfaceexposedtothesolution.TheseworldwidetestsusingSBFhavebeenusedtounderstandbiomineralizationprocessesinhumansandtobeusedasascreeningtooltopredictthepotentialforinvivoapatiteformationonanimplantsurface.However,SBFisanacellular,biomolecule-fre

29、epseudo-physiologicalsolutionformimickinginvivoinorganicchemicalreactionsonlyandisusedunderartificiallycontrolledstaticconditions.Hence,theSBFtest,likeotherinvitrotests,cannotreproduceinvivobiologicallybasedreactionscompletely.SomeoftheselimitationsaregivenintheNOTES1,2,3and4.Theapatitelayerformedin

30、thisSBFtestcan,generally,bedetectedbyconventionalsurfaceanalyticaltechniquessuchasX-raydiffraction(XRD)analysis,scanningelectronmicroscopy(SEM),energydispersiveX-rayspectroscopy(EDX)andFouriertransforminfraredspectroscopy(FT-IR).TheapatiteformedinthisSBFtesthassomesimilaritiestobonemineral(apatite),

31、itisaCa-deficienttypelowcrystallineapatitewhichcontainstheionicspeciesMg2+,Na+,C匕CO3constituteanendorsementbyISOoftheseproducts.-etc.NOTE1ConditionsoftheSBFtestaredifferentfrominvivoconditionsinseveralfactors,e.g.lackofbiologicalsubstances(cells,proteins,etc)thatplayasignificantroleintheultimateform

32、ationofthebone-implantinterface,lackofbodyfluidcirculation,lowercarbonateandhigherchlorideconcentrationsandthepresenceoftris-hydroxymethylaminomethane(TRIS)buffer.NotethatallthesefactorsaffectapatiteformationinanSBFtestJ6,ZandcanaccountforthediscrepancybetweentheSBFtestresultsandinvivoresults.NOTE2B

33、iologicalresponses(biomolecularevents,cellularresponses,immunologicalresponses,toxicity,etc.)cannotbeevaluatedbytheSBFtest.NOTE3Theglasscompositionsusedasreferenceglassesinthisdocument(intheNa2O-CaO-SiO2glassformingsystemhaveshownapositivecorrelationbetweenbone-formingabilityinabonedefectofarabbitan

34、dapatiteformingabilityinthisSBFtest网.NOTE4Therelationshipbetweentheinvitroformationofanapatite-likeminerallayerasproposedinthisdocumentandtheultimateinvivoresponseoftheimplantmaterialisnotdirectandissubjecttomanyvariables.Bioglass(45S5andotherglassesinthisSerieS)JU-Bl田CaO-Sipglasses,囹CeraboneA-WrHCe

35、ravital(g)-typeglass-ceramic，sinteredhydroxyapatite1LandalkaliandheattreatedtitaniummetalJ11Lallhaveshowntobondtobonemostlikelythroughanapatitelayerdevelopedatthebone-implantinterfaceinvivoandallformanapatite-likeminerallayerontheirsurfacesinanSBFtest.12!However,therearematerialswithrelativelyhighso

36、lubilitysuchasbeta-tricalciumphosphate(Ca(PO)引angaldumcarbonate2thatcan_bondtobonewithoutforminganapatitelayerontheirsurfaces,eitherinvitro(InanSBFtestorinvivo.Apatiteformationinthistestisaresultofchemicallydrivencalciumphosphateprecipitation,crystallizationandgrowth.Somematerialformulationsresorbto

37、oquicklytoformadirectbondtolivingbone,suchascalciumsulfatehemihydrate,calciumsulfatedihydrateanddicalciumphosphatedihydrate;buttheycanformanapatite-likelayerontheirsurfacesinanSBFtest.%Inaddition,eventoxicmaterialsandmaterialsknowntocauseinflammatoryresponsesuponimplantationinbonecanformanapatite-li

38、kelayerwhensoakedinSBF.Therefore,thisdocumentcanonlybeusedforinitialscreeningofimplantmaterialstoevaluatetheirpotentialuseinboneimplantationsites.ImplantsforsurgeryMaterialsSimulatedbodyfluid(SBF)preparationprocedureandtestmethodtodetectapatiteformationinSBFforinitialscreeningofbonecontactingimplant

39、materials1ScopeThisdocumentspecifiesaprocedureforpreparingthesimulatedbodyfluid(SBF)andatestmethodforuseasaninitialscreeningtoolintheevaluationofapatiteformationonthesurfacesofbone-contactingimplantmaterials.NOTE1TheresultsofthisSBFtest(seeClause7alonedonotestablishbone-bondingability.Thetestcanbeus

40、edalongwithotherinvitroandinvivoconfirmatoryteststoestablishanimplantmateriasabilitytobondwithbonetissueinvivo.Thisdocumentislimitedtoanassessmentoftheinvitroapatite-formingabilityofbulkysolidmaterialsusedforbone-contactingimplantsandisnotintendedtobeusedtoevaluatethisabilityofporousmaterials,partic

41、ulatematerialsorsolutemoleculesorions.NOTE2PorousmaterialsareexcludedfromtestspecimensbecausetheyrequirealargevolumeofSBFduetohighsurfacearea,andoftenhavedifficultyinpenetrationofSBFintotheirporousbodies.Furthermore,analysisoftheinnersurfacesofporousmaterialsisdifficultbythemethoddescribedinthisdocu

42、ment.2 NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO3611lGeometrica

43、lproductspecifications(GPS)DimensionalmeasuringequipmentDesignandmetrologicalcharacteristicsOfmicrometersforexternalmeasurementsISO3696,WaterforanalyticallaboratoryuseSpecificationandtestmethodsISO13385-llGeometricalproductspecifications(GPS)DimensionalmeasuringequipmentPart1:Designandmetrologicalch

44、aracteristicsOfcallipersISO13385-2,Geometricalproductspecifications(GPS)DimensionalmeasuringequipmentPart2:DesignandmetrologicalcharacteristicsofcalliperdepthgaugesISO14630,Non-activesurgicalimplantsGeneralrequirements3 TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO

45、14630andthefollowingapply.ISOandIECmaintainterminologydatabasesforuseinstandardizationatthefollowingaddresses: ISOOnlinebrowsingplatform:availableathttps:WWW.iso.org/obp IECElectropedia:availableathttps:/www.olectropedia.org/1.1apatitenon-stoichiometricnano-crystallinehydroxyapatitecontainingC32lNa+

46、Mg2+andvacancyinitscrystallattice1.2apatite-formingabilitycapabilityofamaterialtoformapatite(3.1)onitssurface1.3simulatedbodyfluidSBFbiomolecule-freeandacellularaqueoussolutionsimilarinionconcentrationsandpHtohumanbloodplasma1.4referenceglassclassofglasseswithchemicalcompositionsshowingknownapatite

47、formingabilities(3.2)whensoakedinsimulatedbodyfluid(SBF),usedforevaluatingamaterialapatite-formingabilityNote1toentry:SomeapplicablechemicalcompositionsareshowninAnnexB.Glasseswiththesechemicalcompositionshaveshownapatite-formingabilitieswhenimplantedinrabbitbonedefects.出Glasseswithsimilarcompositi

48、onshavebeenappliedclinicallyasbone-contactingimplantssuchasmiddleearreplacementProStheSeS困.1.5X-raydiffractionXRDmethodforanalysingcrystallinestructureofamaterialfromadiffractionpatternobtainedbyX-ray1.6boneimplantmaterialimplantmaterialintendedtobeincontactwithbone,forwhichtheapatite-formingability(3.2)isinvestigated4 Apparatusandmaterials4.1 Balance,capableofmeasuringamasswithamaximumlimitoferrorof0,2mg.4.2 Temperaturecontrolledwaterbathequippedwithmagneticstirrer,ca