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1、ReferencenumberISO15194:2002(E)?ISO2002INTERNATIONALSTARDISO15194Firstedition20021001Invitrodiagnosticmedicaldevices—Measurementofquantitiesinsamplesofbiologicaligin—DeionofreferencematerialsDispositifsmdicauxdediagnosti

2、cinvitro—Mesuredesgreursdansleschantillonsd’iginebiologique—DeiondesmatriauxderfrenceCopyrightInternationalganizationfStardizationProvidedbyIHSunderlicensewithISOLicensee=NASATechnicalStards19972545001NotfResale041920070

3、3:28:00MDTNoreproductionwkingpermittedwithoutlicensefromIHS```````````````````````ISO15194:2002(E)?ISO2002–AllrightsreservediiiFewdISO(theInternationalganizationfStardization)isawldwidefederationofnationalstardsbodies(IS

4、Omemberbodies).ThewkofpreparingInternationalStardsisnmallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectfwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Int

5、ernationalganizationsgovernmentalnongovernmentalinliaisonwithISOalsotakepartinthewk.ISOcollabatescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstardization.InternationalStardsare

6、draftedinaccdancewiththerulesgivenintheISOIECDirectivesPart3.ThemaintaskoftechnicalcommitteesistoprepareInternationalStards.DraftInternationalStardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesfvoting.Pub

7、licationasanInternationalStardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStardmaybethesubjectofpatentrights.ISOshallnotbeheldresponsi

8、blefidentifyinganyallsuchpatentrights.InternationalStardISO15194waspreparedbytheEuropeanCommitteefStardization(asEN12287:1998)wasadoptedunderaspecial“fasttrackprocedure”byTechnicalCommitteeISOTC212Clinicallabatytestingin

9、vitrodiagnostictestsystemsinparallelwithitsapprovalbytheISOmemberbodies.CopyrightInternationalganizationfStardizationProvidedbyIHSunderlicensewithISOLicensee=NASATechnicalStards19972545001NotfResale0419200703:28:00MDTNor

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