BS ISO 23317 2025.docx

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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.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorldTrade