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Animalmodel:species:usuallyratsorrabbits,largeranimalsmustbejustifiedANSI/AAMI/ISOBiologicalevaluationofmedicaldevices PartTestsforlocal effectsafterimplantation.ISOBiologicalevaluationofmedicaldevices PartTestsforlocaleffectsafterimplantationSpecifiestestmethodsfortheassessmentof thelocaleffectsafterimplantationofPlanningoftestsISOember1,BiologicalevaluationofmedicaldevicesPartTestsforlocaleffectsafterimplantation ObjectivesandusesofAAMIstandardsandrecommendedpracticesThisisapreviewof"ISO"thefullversionfromtheANSIstoreThispartofISOappliesto iTehStandardsISOCurrentISO(E) PartIdentificationandquantificationofdegradationproductsfrommetalsandalloys PartToxicokineticstudydesign fordegradationproductsandleachables1DocumentHistoryLanguage(s):English,FrenchAvailableformat(s):Hardcopy,PDF,PDFUsers,PDFUsers, PDFUsersThispartofISOspecifiestestmethodsfortheassessmentofthelocaleffectsafterimplantationofbiomaterialsintendedforuseinmedicaldevices BiologicalevaluationofmedicaldevicesPartTestsforlocaleffectsafterimplantation.ClickheretopurchasethefullversionfromtheANSIstore.emberICS SupersedesENISOEnglishVersion.AbstractThisisapreviewISOspecifiestestmethodsfortheassessmentofthelocaleffectsafterimplantationofbiomaterials intendedforuseinmedicaldevicesPublisheddatePublisher:InternationalOrganizationforStandardizationISOcopyrightofficeChdeBlandonnet•CPCH, ANSI/AAMI/ISO;Biologicalevaluationofmedicaldevices PartTestsforlocaleffectsafterimplantationBiologicalevaluationofmedicaldevicesPartNo (ISO)“BiologicalevaluationofmedicaldevicesPartTestsforlocaleffectsafterimplantation”issuedby“InternationalOrganizationforStandardization”inits PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequestersiteofimplantasappropriatetothe kindofdevice:bone,tissue,subcutaneousISOspecifiestestmethodsfortheassessmentofthelocaleffectsafterimplantationofbiomaterialsintendedforusein medicaldevices.BiologicalevaluationofmedicaldevicesPartTestsforlocaleffectsafterimplantation(ISO)AmericanNationalStandard.PartTestsforlocaleffects afterimplantation(ISO)BSENISOBRITISHSTANDARDISOconsistsofthefollowingparts,underthegeneraltitleBiologicalevaluationofmedicaldevices: PartEvaluationandtestingwithinariskmanagementprocessNORMEEUROPÉENNEEUROPÄISCHENORMISOappliestomaterialsthataresolidand non-absorbable,non-solid,suchasporousmaterials,liquids,gels,pastes,andparticulates,andISO(E)ISO,Biologicalevaluationofmedicaldevices Toxicokineticstudydesignfor PartdegradationproductsandleachablesTermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitions giveninISO,ISO,ISO,ISOandthefollowingapplyabsorb/absorptionClickheretopurchase