BS ISO 23317 2025.docx

BSISO23317:2025ImplantsforsurgeryMaterialsSimulatedbodyfluid(SBF)preparationprocedureandtestmethodtodetectapatiteformationinSBFforinitialscreeningofbone-contactingimplantmaterialsbsi.NationalforewordThisBritishStandardistheUKimplementationofISO23317:2025.ItsupersedesBSISO23317:2014,whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH150llMaterialsforsurgicalimplants.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitscommitteemanager.ContractualandlegalconsiderationsThispublicationhasbeenpreparedingoodfaith,howevernorepresentation,warranty,assuranceorundertaking(expressorimplied)isorwillbemade,andnoresponsibilityorliabilityisorwillbeacceptedbyBSIinrelationtotheadequacy,accuracy,completenessorreasonablenessofthispublication.Allandanysuchresponsibilityandliabilityisexpresslydisclaimedtothefullextentpermittedbythelaw.Thispublicationisprovidedasis,andistobeusedattherecipientsownrisk.Therecipientisadvisedtoconsiderseekingprofessionalguidancewithrespecttoitsuseofthispublication.Thispublicationisnotintendedtoconstituteacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2025PublishedbyBSIStandardsLimited2025ISBN9780539249705ICS11.040.40CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30June2025.Amendments/corrigendaissuedsincepublicationDateTextaffectedInternationalStandardISO23317Fourthedition2025-06ImplantsforsurgeryMaterialsSimulatedbodyfluid(SBF)preparationprocedureandtestmethodtodetectapatiteformationinSBFforinitialscreeningofbonecontactingimplantmaterialsImplantsChirurgicauxMateriauxModeoperatoiredepreparationdefluidecorporelsimule(FCS)etmethoded'essaipourdetecterlaformationd,apatitedansIeFCSpourVetudepreliminairedemateriauxd,implantencontactavecVosReferencenumberISO23317:2025(en)COPYRIGHTPROTECTEDDOCUMENT©ISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Apparatusandmaterials25 Testspecimen35.1 Testspecimenshapeanddimensions35.2 Testspecimenpreparation35.3 Testspecimencharacterization36 Simulatedbodyfluid46.1 General46.2 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)ApparatusforpreparingSBF.L2Annex B (informative)Preparationofreferenceglasses13Bibliography14ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）patent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTrade