体外诊断试剂IVD欧盟EN13612性能评估部分中英文13页精选文档.docx
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体外诊断试剂IVD欧盟EN13612性能评估部分中英文13页精选文档
3Generalrequirementsfortheperformanceevaluation
唐宋或更早之前，针对“经学”“律学”“算学”和“书学”各科目，其相应传授者称为“博士”，这与当今“博士”含义已经相去甚远。
而对那些特别讲授“武事”或讲解“经籍”者，又称“讲师”。
“教授”和“助教”均原为学官称谓。
前者始于宋，乃“宗学”“律学”“医学”“武学”等科目的讲授者；而后者则于西晋武帝时代即已设立了，主要协助国子、博士培养生徒。
“助教”在古代不仅要作入流的学问，其教书育人的职责也十分明晰。
唐代国子学、太学等所设之“助教”一席，也是当朝打眼的学官。
至明清两代，只设国子监（国子学）一科的“助教”，其身价不谓显赫，也称得上朝廷要员。
至此，无论是“博士”“讲师”，还是“教授”“助教”，其今日教师应具有的基本概念都具有了。
3.1Responsibilitiesandresources
要练说，得练看。
看与说是统一的，看不准就难以说得好。
练看，就是训练幼儿的观察能力，扩大幼儿的认知范围，让幼儿在观察事物、观察生活、观察自然的活动中，积累词汇、理解词义、发展语言。
在运用观察法组织活动时，我着眼观察于观察对象的选择，着力于观察过程的指导，着重于幼儿观察能力和语言表达能力的提高。
Themanufacturertakestheresponsibilityfortheinitiationand/ortheconductofaperformanceevaluationstudy.Heshalldefinetheresponsibilityandtheinterrelationofallpersonnelwhomanage
单靠“死”记还不行,还得“活”用,姑且称之为“先死后活”吧。
让学生把一周看到或听到的新鲜事记下来,摒弃那些假话套话空话,写出自己的真情实感,篇幅可长可短,并要求运用积累的成语、名言警句等,定期检查点评,选择优秀篇目在班里朗读或展出。
这样,即巩固了所学的材料,又锻炼了学生的写作能力,同时还培养了学生的观察能力、思维能力等等,达到“一石多鸟”的效果。
andconducttheperformanceevaluationofIVDMDs,particularlyforpersonnelwhoneedthe
organisationalfreedomandauthorityto
a）assessthevalidityoftestresultsanddataalreadyavailable;
b）specifyperformanceclaimswhichshallbefurtherexaminedorconfirmed;
c）specifyanddocumenttheevaluationplanandthetestprocedures;
d）preparetheevaluationreport.
Themanufacturershallappointaco-ordinatorwithoverallresponsibilityoftheperformanceevaluation
study.Theco-ordinatorshallhimselfassurethatadequateresourcesareavailable.Theinvestigator
shallensurethattheevaluationplanisfollowedathislocationandthatthestudyisappropriately
reviewedfromanethicalpointofview.
3.2Documentation
Thedocumentationoftheperformanceevaluationstudyshallcontainthefilesrelatingtoclauses3to
7ofthisstandardandshallbepartofthetechnicaldocumentationoftheIVDMD.
3.3Finalassessmentandreview
Theco-ordinatorshallassessanddocumentwhichperformanceclaimsaremet,statewhetherclaims
arenotmetandgiverecommendationsforcorrectiveactions,wherenecessary.
Theresponsiblemanagementofthemanufacturershallmakesurethattheresultsoftheperformance
evaluationstudyandtherecommendationsforcorrectiveactionsarecarefullyconsideredandproperly
documentedbeforeissuingadeclarationofconformity.
4Organisationofaperformanceevaluationstudy
4.1Preconditions
Beforestartingaperformanceevaluationstudyitshallbeensuredbytheco-ordinatorthat
a）theperformanceclaimsoftheIVDMDwhicharethesubjectofthestudyarespecified;
b）theIVDMDhasbeenmanufacturedundercontrolledproductionprocessesandconditions;
c）theIVDMDtobeevaluatedmeetsthequalitycontrolreleasespecifications;
d）asufficientnumberofsamplesoftheIVDMDcanbeprovidedduringtheentireperiodofthe
performanceevaluationstudy;
e）alllegalrequirementsforperformanceevaluationstudiesaremet;
f）theinvestigator（s）is（are）adequatelyskilledandtrainedtoconductthestudyandthenecessary
resourcesareavailable.
4.2Evaluationplan
Theevaluationplanshallstatethepurposeonscientific,technicalormedicalgrounds,thescopeof
theevaluation,thestructureandorganizationofthestudyandthenumberofdevicesconcerned.
Definingtheobjectiveofthestudy,theco-ordinatorshallhaveassessedwhichperformanceclaims
arealreadyverifiedbydataorscientificliterature.
Theevaluationplanshallbedesignedtominimisetherequirementsforinvasivesampling.Inthecase
ofIVDMDsforself-testingitshallbeensuredthattheevaluationplanisappropriateandacceptableto
usersandtheinformationprovidedshallbeclearandeasilyunderstood.
Theevaluationplanshallspecify
a）thattheinvestigator（s）is（are）adequatelyskilledandtrainedtousetheIVDMD;
b）thelistoflaboratoriesorotherinstitutionstakingpartintheperformanceevaluationstudy;forselftesting,
thelocationandnumberoflaypersonsinvolved;
c）thetime-table;
d）thenecessaryminimumnumberofprobandsfromwhomspecimensarecollectedbyinvasive
proceduresinordertoadequatelyassesstheperformanceoftheIVDMD;
e）instructionsforuseincludingadescriptionoftheconditionsofuse;
f）theperformanceclaims（e.g.analyticalsensitivity,diagnosticsensitivity,analyticalspecificity,
diagnosticspecificity,accuracy,repeatability,reproducibility）tobevalidated;
g）theformatofperformancestudyrecords.
4.3Sitesandresources
Ingeneral,theperformancestudyprocedure（s）shallbecarriedoutunderconditionsreflectingthe
relevantintendedconditionsofuse.
Theco-ordinatorshalltaketheresponsibilityfortheproperconductoftheperformanceevaluation
studyatallsites.Allinvestigatorsshallbenamed.
Theco-ordinatorshallensureadequatecompetenceandskillatallsitesinvolvedandthatthe
necessaryresourcesareavailable.
WherelaypersonsareinvolvedinaperformanceevaluationstudyofanIVDMDforself-testing,the
locationofthestudyandthenumberofpersonsshallbegiven.Theco-ordinatorshallspecifythe
criteriafortheselectionofarepresentativepanel.
Especiallyforstudiesinvolvinglaypersonsitshallbeensuredthatthesepersonsdonotreceive
additionalinformationontheuseoftheIVDMDapartfromthatwhichisprovidedwiththeIVDMD
whenitisplacedonthemarketbecausethecomprehensionofthemanufacturer'sinstructionsforuse
isoneoftheimportantaspectsofthestudy.ltshallalsobeensuredthattheuntrainedperson（s）do
notreceiveanyadditionalinformationorhelp,e.g.fromatutor,otherthanthetrainingspecifiedand
providedbythemanufacturerintheinstructionsforuse.
4.4Basicdesigninformation
Theco-ordinatorshallprovidetheinvestigator（s）withsufficientinformationinordertounderstandthe
functionandapplicationoftheIVDMDand,wherenecessary,theinvestigatorshallmakehimself
familiarwiththeIVDMDanditsapplication.Theinformationprovidedshallincludeastatementthat
thedeviceinquestionconformswiththerequirementsoftheDirective98/79/ECapartfromthosetobe
evaluated.
4.5Experimentaldesign
Theexperimentalprocedurestovalidateeachperformanceclaimsubjecttotheperformance
evaluationstudyshallbedocumentedintheevaluationplan.
Specialconsiderationinperformanceevaluationstudiesofreagents/kitsshallbegiven,where
applicable,tothefollowing:
–specificationoftype（e.g.serum,plasma,urine）andproperties（e.g.concentrationrange,age
andsexoftheprobandpopulation）ofspecimensappropriatetotheintendeduse;
–probandstobeenrolled;
–suitability,stabilityandvolumeofspecimensandspecimenexclusioncriteria;
–blindprocedures,wherenecessary;
–reagentstability;
–inclusionofcommoninterferingfactors,causedbyspecimenconditionorthe
pathological/physiologicalstatusofthespecimendonorortreatment;
–conditionsforusewhichcanbereasonablyanticipated;specialattentionshallbepaidtothe
conditionsofusebylaypersons;
–selectionofanappropriatereferencemeasurementprocedureandreferencematerialof
higherorder,whereavailable;
–determinationofthestatusofspecimens（forqualitativetestswithanominalorordinalscale）;
–calibrationprocedures,includingtraceability,whereappropriate;
–appropriatemeansofcontrol;
–limitationsofthetest;
–criteriaforre-examinationanddataexclusion;
–availabilityofadditionalinformationconcerningthespecimenordonoriffollow-upof
unexpectedresultsisrequired;
–appropriatemeasurestoreduceriskofinfectiontotheuser.
Wherethestudyisintendedtovalidatetheperformanceclaimsofaninstrumentspecialconsideration
shallbegivenadditionallytothefollowing:
–maintenanceandcleaning;
–carry-overeffects;
–softwarevalidation.
NOTEFortheinvestigationofthetechnicalaspectsofinstruments,otherstandardscanberelevant.
4.6Performancestudyrecords
Theperformancestudyrecordsshall
–refertotheexperimentalproceduresintheevaluationplan;
–beunequivocallyidentifiable;
–containorrefertoallresultsandrelatedrelevantdata;
–bepartofthetechnicaldocumentationoftheIVDMD.
Theprotectionofallconfidentialdatashallbeensured.
4.7Observationsandunexpectedoutcomes
Specialattentionshallbepaidtoobservationsandunexpectedoutcomes,e.g.dropouts,outliers,
instabilityofsampleorreagentsignaletc.,non-reproducibility,non-correlationofresultstothe
referenceortothediagnosticpattern,defectsorbreakdowns,softwareerrors,orerrorsignals.
Anydeviationfromthedefinedproceduresshallberecorded.InthecaseofIVDMDsforself-testing,
theinvestigatorortutorshalldulynoteanydifficultyorquestionausermayhaveandanydeviation
fromthemodeofapplicationoftheIVDMDasdescribedbythemanufacturer.
Anysuchobservationshallbeproperlyrecorded.Theco-ordinatorshall,togetherwiththeinvestigator,
tracethecausewheneverpossible.Theresultshallberecordedandshallbepartoftheevaluation
report.
Wherethevalidityoftheexaminationsalreadyperformedmaybequestionablebecauseofan
identifiedsourceoferrorthetestsshallberepeatedafterexclusionofthatcause.
Whereamisuseormisinterpretationoftheinstructionsforusehasbeenthecauseandwherean
unexpectedriskinherenttotheproductdesignorthemodeofapplicationhasbeenidentifiedthisshall
beclearlystated.
Theproposalsoftheinvestigator（s）andtheco-ordinatorforanyimprovementoftheIVDMDand/orits
applicationshallberecorded.
4.8Evaluationreport
Theco-ordinatorshallestablishanevaluationreport.Itshallcontainadescript
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