体外诊断试剂IVD欧盟EN13612性能评估部分中英文

3 Generalrequirementsfortheperformanceevaluation3.1 ResponsibilitiesandresourcesThemanufacturertakestheresponsibilityfortheinitiationand/ortheconductofaperformanceevaluationstudy.HeshalldefinetheresponsibilityandtheinterrelationofallpersonnelwhomanageandconducttheperformanceevaluationofIVDMDs,particularlyforpersonnelwhoneedtheorganisationalfreedomandauthoritytoa) assessthevalidityoftestresultsanddataalreadyavailable;b) specifyperformanceclaimswhichshallbefurtherexaminedorconfirmed;c) specifyanddocumenttheevaluationplanandthetestprocedures;d) preparetheevaluationreport.Themanufacturershallappointaco-ordinatorwithoverallresponsibilityoftheperformanceevaluationstudy.Theco-ordinatorshallhimselfassurethatadequateresourcesareavailable.Theinvestigatorshallensurethattheevaluationplanisfollowedathislocationandthatthestudyisappropriatelyreviewedfromanethicalpointofview.3.2 DocumentationThedocumentationoftheperformanceevaluationstudyshallcontainthefilesrelatingtoclauses3to7ofthisstandardandshallbepartofthetechnicaldocumentationoftheIVDMD.3.3 FinalassessmentandreviewTheco-ordinatorshallassessanddocumentwhichperformanceclaimsaremet,statewhetherclaimsarenotmetandgiverecommendationsforcorrectiveactions,wherenecessary.Theresponsiblemanagementofthemanufacturershallmakesurethattheresultsoftheperformanceevaluationstudyandtherecommendationsforcorrectiveactionsarecarefullyconsideredandproperlydocumentedbeforeissuingadeclarationofconformity.4 Organisationofaperformanceevaluationstudy4.1PreconditionsBeforestartingaperformanceevaluationstudyitshallbeensuredbytheco-ordinatorthata) theperformanceclaimsoftheIVDMDwhicharethesubjectofthestudyarespecified;b) theIVDMDhasbeenmanufacturedundercontrolledproductionprocessesandconditions;c) theIVDMDtobeevaluatedmeetsthequalitycontrolreleasespecifications;d) asufficientnumberofsamplesoftheIVDMDcanbeprovidedduringtheentireperiodoftheperformanceevaluationstudy;e) alllegalrequirementsforperformanceevaluationstudiesaremet;f) theinvestigat...