ISO 10993-5:2009医疗器械生物学评价 第5部分:体外细胞毒性试验_第1页
ISO 10993-5:2009医疗器械生物学评价 第5部分:体外细胞毒性试验_第2页
ISO 10993-5:2009医疗器械生物学评价 第5部分:体外细胞毒性试验_第3页
ISO 10993-5:2009医疗器械生物学评价 第5部分:体外细胞毒性试验_第4页
ISO 10993-5:2009医疗器械生物学评价 第5部分:体外细胞毒性试验_第5页
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REFERENCENUMBERISO1099352009EISO2009INTERNATIONALSTANDARDISO109935THIRDEDITION20090601BIOLOGICALEVALUATIONOFMEDICALDEVICESPART5TESTSFORINVITROCYTOTOXICITYVALUATIONBIOLOGIQUEDESDISPOSITIFSMDICAUXPARTIE5ESSAISCONCERNANTLACYTOTOXICITINVITROCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISOLICENSEEISTANBULTEKNIKUNIVERSTESI/5956919001,USERJICHENG,PIAONOTFORRESALE,06/11/2009164528MDTNOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO1099352009EPDFDISCLAIMERTHISPDFFILEMAYCONTAINEMBEDDEDTYPEFACESINACCORDANCEWITHADOBESLICENSINGPOLICY,THISFILEMAYBEPRINTEDORVIEWEDBUTSHALLNOTBEEDITEDUNLESSTHETYPEFACESWHICHAREEMBEDDEDARELICENSEDTOANDINSTALLEDONTHECOMPUTERPERFORMINGTHEEDITINGINDOWNLOADINGTHISFILE,PARTIESACCEPTTHEREINTHERESPONSIBILITYOFNOTINFRINGINGADOBESLICENSINGPOLICYTHEISOCENTRALSECRETARIATACCEPTSNOLIABILITYINTHISAREAADOBEISATRADEMARKOFADOBESYSTEMSINCORPORATEDDETAILSOFTHESOFTWAREPRODUCTSUSEDTOCREATETHISPDFFILECANBEFOUNDINTHEGENERALINFORELATIVETOTHEFILETHEPDFCREATIONPARAMETERSWEREOPTIMIZEDFORPRINTINGEVERYCAREHASBEENTAKENTOENSURETHATTHEFILEISSUITABLEFORUSEBYISOMEMBERBODIESINTHEUNLIKELYEVENTTHATAPROBLEMRELATINGTOITISFOUND,PLEASEINFORMTHECENTRALSECRETARIATATTHEADDRESSGIVENBELOWCOPYRIGHTPROTECTEDDOCUMENTISO2009ALLRIGHTSRESERVEDUNLESSOTHERWISESPECIFIED,NOPARTOFTHISPUBLICATIONMAYBEREPRODUCEDORUTILIZEDINANYFORMORBYANYMEANS,ELECTRONICORMECHANICAL,INCLUDINGPHOTOCOPYINGANDMICROFILM,WITHOUTPERMISSIONINWRITINGFROMEITHERISOATTHEADDRESSBELOWORISOSMEMBERBODYINTHECOUNTRYOFTHEREQUESTERISOCOPYRIGHTOFFICECASEPOSTALE56CH1211GENEVA20TEL41227490111FAX41227490947EMAILCOPYRIGHTISOORGWEBWWWISOORGPUBLISHEDINSWITZERLANDIIISO2009ALLRIGHTSRESERVEDCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISOLICENSEEISTANBULTEKNIKUNIVERSTESI/5956919001,USERJICHENG,PIAONOTFORRESALE,06/11/2009164528MDTNOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO1099352009EISO2009ALLRIGHTSRESERVEDIIICONTENTSPAGEFOREWORDIVINTRODUCTIONVI1SCOPE12NORMATIVEREFERENCES13TERMSANDDEFINITIONS14SAMPLEANDCONTROLPREPARATION241GENERAL242PREPARATIONOFLIQUIDEXTRACTSOFMATERIAL343PREPARATIONOFMATERIALFORDIRECTCONTACTTESTS444PREPARATIONOFCONTROLS55CELLLINES56CULTUREMEDIUM57PREPARATIONOFCELLSTOCKCULTURE68TESTPROCEDURES681NUMBEROFREPLICATES682TESTONEXTRACTS683TESTBYDIRECTCONTACT784TESTBYINDIRECTCONTACT785DETERMINATIONOFCYTOTOXICITY99TESTREPORT1010ASSESSMENTOFRESULTS11ANNEXAINFORMATIVENEUTRALREDUPTAKENRUCYTOTOXICITYTEST12ANNEXBINFORMATIVECOLONYFORMATIONCYTOTOXICITYTEST19ANNEXCINFORMATIVEMTTCYTOTOXICITYTEST24ANNEXDINFORMATIVEXTTCYTOTOXICITYTEST29BIBLIOGRAPHY34COPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISOLICENSEEISTANBULTEKNIKUNIVERSTESI/5956919001,USERJICHENG,PIAONOTFORRESALE,06/11/2009164528MDTNOREPRODUCTIONORNETWORKINGPERMITTEDWITHOUTLICENSEFROMIHS,ISO1099352009EIVISO2009ALLRIGHTSRESERVEDFOREWORDISOTHEINTERNATIONALORGANIZATIONFORSTANDARDIZATIONISAWORLDWIDEFEDERATIONOFNATIONALSTANDARDSBODIESISOMEMBERBODIESTHEWORKOFPREPARINGINTERNATIONALSTANDARDSISNORMALLYCARRIEDOUTTHROUGHISOTECHNICALCOMMITTEESEACHMEMBERBODYINTERESTEDINASUBJECTFORWHICHATECHNICALCOMMITTEEHASBEENESTABLISHEDHASTHERIGHTTOBEREPRESENTEDONTHATCOMMITTEEINTERNATIONALORGANIZATIONS,GOVERNMENTALANDNONGOVERNMENTAL,INLIAISONWITHISO,ALSOTAKEPARTINTHEWORKISOCOLLABORATESCLOSELYWITHTHEINTERNATIONALELECTROTECHNICALCOMMISSIONIECONALLMATTERSOFELECTROTECHNICALSTANDARDIZATIONINTERNATIONALSTANDARDSAREDRAFTEDINACCORDANCEWITHTHERULESGIVENINTHEISO/IECDIRECTIVES,PART2THEMAINTASKOFTECHNICALCOMMITTEESISTOPREPAREINTERNATIONALSTANDARDSDRAFTINTERNATIONALSTANDARDSADOPTEDBYTHETECHNICALCOMMITTEESARECIRCULATEDTOTHEMEMBERBODIESFORVOTINGPUBLICATIONASANINTERNATIONALSTANDARDREQUIRESAPPROVALBYATLEAST75OFTHEMEMBERBODIESCASTINGAVOTEATTENTIONISDRAWNTOTHEPOSSIBILITYTHATSOMEOFTHEELEMENTSOFTHISDOCUMENTMAYBETHESUBJECTOFPATENTRIGHTSISOSHALLNOTBEHELDRESPONSIBLEFORIDENTIFYINGANYORALLSUCHPATENTRIGHTSISO109935WASPREPAREDBYTECHNICALCOMMITTEEISO/TC194,BIOLOGICALEVALUATIONOFMEDICALDEVICESTHISTHIRDEDITIONCANCELSANDREPLACESTHESECONDEDITIONISO1099351999WHICHHASBEENTECHNICALLYREVISEDISO10993CONSISTSOFTHEFOLLOWINGPARTS,UNDERTHEGENERALTITLEBIOLOGICALEVALUATIONOFMEDICALDEVICESPART1EVALUATIONANDTESTINGWITHINARISKMANAGEMENTPROCESSPART2ANIMALWELFAREREQUIREMENTSPART3TESTSFORGENOTOXICITY,CARCINOGENICITYANDREPRODUCTIVETOXICITYPART4SELECTIONOFTESTSFORINTERACTIONSWITHBLOODPART5TESTSFORINVITROCYTOTOXICITYPART6TESTSFORLOCALEFFECTSAFTERIMPLANTATIONPART7ETHYLENEOXIDESTERILIZATIONRESIDUALSPART9FRAMEWORKFORIDENTIFICATIONANDQUANTIFICATIONOFPOTENTIALDEGRADATIONPRODUCTSPART10TESTSFORIRRITATIONANDSKINSENSITIZATIONPART11TESTSFORSYSTEMICTOXICITYPART12SAMPLEPREPARATIONANDREFERENCEMATERIALSPART13IDENTIFICATIONANDQUANTIFICATIONOFDEGRADATIONPRODUCTSFROMPOLYMERICMEDICALDEVICESPART14IDENTIFICATIONANDQUANTIFICATIONOFDEGRADATIONPRODUCTSFROMCERAMICSPART15IDENTIFICATIONANDQUANTIFICATIONOFDEGRADATIONPRODUCTSFROMMETALSANDALLOYSCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICEN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