体外诊断试剂ivd欧盟en13612性能评估部分中英

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1、3Generalrequirementsfortheperformanceevaluation3.1ResponsibilitiesandresourcesThemanufacturertakestheresponsibilityfortheinitiationand/ortheconductofaperformanceevaluationstudy.Heshalldefinetheresponsibilityandtheinterrelationofallpersonnelwhomanageandconducttheperformanceevaluation

2、ofIVDMDs,particularlyforpersonnelwhoneedtheorganisationalfreedomandauthoritytoa)assessthevalidityoftestresultsanddataalreadyavailable;b)specifyperformanceclaimswhichshallbefurtherexaminedorconfirmed;c)specifyanddocumenttheevaluationplanandthetestprocedures;d)preparetheevaluationrepo

3、rt.Themanufacturershallappointaco-ordinatorwithoverallresponsibilityoftheperformanceevaluationstudy.Theco-ordinatorshallhimselfassurethatadequateresourcesareavailable.Theinvestigatorshallensurethattheevaluationplanisfollowedathislocationandthatthestudyisappropriatelyreviewedfromanet

4、hicalpointofview.3.2DocumentationThedocumentationoftheperformanceevaluationstudyshallcontainthefilesrelatingtoclauses3to7ofthisstandardandshallbepartofthetechnicaldocumentationoftheIVDMD.3.3FinalassessmentandreviewTheco-ordinatorshallassessanddocumentwhichperformanceclaimsaremet,sta

5、tewhetherclaimsarenotmetandgiverecommendationsforcorrectiveactions,wherenecessary.Theresponsiblemanagementofthemanufacturershallmakesurethattheresultsoftheperformanceevaluationstudyandtherecommendationsforcorrectiveactionsarecarefullyconsideredandproperlydocumentedbeforeissuingadecl

6、arationofconformity.4Organisationofaperformanceevaluationstudy4.1PreconditionsBeforestartingaperformanceevaluationstudyitshallbeensuredbytheco-ordinatorthata)theperformanceclaimsoftheIVDMDwhicharethesubjectofthestudyarespecified;b)theIVDMDhasbeenmanufacturedundercontrolledproduction

7、processesandconditions;c)theIVDMDtobeevaluatedmeetsthequalitycontrolreleasespecifications;d)asufficientnumberofsamplesoftheIVDMDcanbeprovidedduringtheentireperiodoftheperformanceevaluationstudy;e)alllegalrequirementsforperformanceevaluationstudiesaremet;f)theinvestigator(s)is(are)ad

8、equatelyskilledandt