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1、ReferencenumberISO109937:2008(E)?ISO2008INTERNATIONALSTARDISO109937Secondedition20081015Biologicalevaluationofmedicaldevices—Part7:Ethyleneoxidesterilizationresidualsvaluationbiologiquedesdispositifsmdicaux—Partie7:Rsidu

2、sdestrilisationloxydedthylneISO109937:2008(E)ivFewdISO(theInternationalganizationfStardization)isawldwidefederationofnationalstardsbodies(ISOmemberbodies).ThewkofpreparingInternationalStardsisnmallycarriedoutthroughISOte

3、chnicalcommittees.Eachmemberbodyinterestedinasubjectfwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.InternationalganizationsgovernmentalnongovernmentalinliaisonwithISOalsotakepartinth

4、ewk.ISOcollabatescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstardization.InternationalStardsaredraftedinaccdancewiththerulesgivenintheISOIECDirectivesPart2.Themaintaskoftechni

5、calcommitteesistoprepareInternationalStards.DraftInternationalStardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesfvoting.PublicationasanInternationalStardrequiresapprovalbyatleast75%ofthememberbodiescasti

6、ngavote.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsiblefidentifyinganyallsuchpatentrights.ISO109937waspreparedbyTechnicalCommitteeISOTC194Biol

7、ogicalevaluationofmedicaldevices.Thissecondeditioncancelsreplacesthefirstedition(ISO109937:1995)whichhasbeentechnicallyrevised.ISO10993consistsofthefollowingpartsunderthegeneraltitleBiologicalevaluationofmedicaldevices:?

8、Part1:Evaluationtestingwithinariskmanagementsystem?Part2:Animalwelfarerequirements?Part3:Testsfgenotoxicitycarcinogenicityreproductivetoxicity?Part4:ionoftestsfinteractionswithblood?Part5:Testsfinvitrocytotoxicity?Part6:

9、Testsflocaleffectsafterimplantation?Part7:Ethyleneoxidesterilizationresiduals?Part9:Framewkfidentificationquantificationofpotentialdegradationproducts?Part10:Testsfirritationskinsensitization?Part11:Testsfsystemictoxicit

10、y?Part12:Samplepreparationreferencematerials?Part13:Identificationquantificationofdegradationproductsfrompolymericmedicaldevices?Part14:Identificationquantificationofdegradationproductsfromceramics?Part15:Identificationq

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