IVD产品CE认证基本要求检查表.docx

IVD产品CE认证基本要求检查表.docxordingtoDirective98/79/EC,oninvitrodiagnoSticmedicaldevicesDevice:Trademark:Manufacturer:Distributor:Accessories:Draftedby: Date:Reviewedby: Date:Date:Approvedby:,whenusedundertheconditionsandforthepurposesintended,promise,directlyorindirectly,theclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,・,ountofthegenerallyacknowledgedstateoftheart..Inselectingthemostappropriatesolutions,themanufacturermustapplythefollowingprinciplesinthefollowingorder:eliminateorreducerisksasfaraspossible(inherentlysafedesignandconstruction)whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated・-ingsoftheprotectionmeasuresadopted・(2)(b),asspecifiedbythemanufacturer,ountofthegenerallyacknowledgedstateoftheartTheymustachievetheperformances,inparticular,whereappropriate,intermsofanalyticalsensitivity,diagnosticsensitivity,analyticalspecificity,diagnoSticspecificity,accuracy,repeatability,reproducibility,includingcontrolofknownrelevantinterference,andlimitsofdetection,.Thecharacteristicsandperformaneereferredtoinsections1and3mustnotbeadverselyaffectedtosuchadegreethatthehealthorthesafetyofthepatientsortheuserand,whereapplicable,promisedduringthelifetimeofthedeviceasindicatedbythemanufacturer,urduringnormalconditionsofuse・Whennolifetimeisstated,thesameappliesforthelifetimereasonablytobeexpectedofadeviceofthatkind,havingregardtotheintendedpurposean