IVD产品CE认证大体要求检查表.docx

IVD产品CE认证大体要求检查表.docx

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IVD产品CE认证大体要求检查表

AnnexI

EssentialRequirements

accordingtoDirective98/79/EC,oninvitrodiagnosticmedicaldevices

Device:

Trademark:

Manufacturer:

Distributor:

Accessories:

Draftedby:

Date:

Reviewedby:

Date:

Approvedby:

Date:

A.

GENERALREQUIREMENTS

1.

Thedevicemustbedesignedandmanufacturedinsuchawaythat,whenusedundertheconditionsandforthepurposesintended,theywillnotcompromise,directlyorindirectly,theclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,orthesafetyofproperty.Anyriskswhichmaybeassociatedwiththeirusemustbeacceptablewhenweighedagainstthebenefitstothepatientandbecompatiblewithahighlevelofprotectionofhealthandsafety.

2.

Thesolutionsadoptedbythemanufacturerforthedesignandconstructionofthedevicesmustconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart..

Inselectingthemostappropriatesolutions,themanufacturermustapplythefollowingprinciplesinthefollowingorder:

-eliminateorreducerisksasfaraspossible（inherentlysafedesignandconstruction）-whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated.-informusersoftheresidualrisksduetoshortcomingsoftheprotectionmeasuresadopted.

3.

ThedevicesmustbedesignedandmanufacturedinsuchawaythattheyaresuitableforthepurposesreferredtoinArticle1

（2）（b）,asspecifiedbythemanufacturer,takingaccountofthegenerallyacknowledgedstateoftheart.Theymustachievetheperformances,inparticular,whereappropriate,intermsofanalyticalsensitivity,diagnosticsensitivity,analyticalspecificity,diagnosticspecificity,accuracy,repeatability,reproducibility,includingcontrolofknownrelevantinterference,andlimitsofdetection,statedbythemanufacturer.

Thetraceabilityofvaluesassignedtocalibratorsand/orcontrolmaterialsmustbeassuredthroughavailablereferencemeasurementproceduresand/oravailablereferencematerialsofahigherorder.

4.

Thecharacteristicsandperformancereferredtoinsections1and3mustnotbeadverselyaffectedtosuchadegreethatthehealthorthesafetyofthepatientsortheuserand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedeviceasindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuse.Whennolifetimeisstated,thesameappliesforthelifetimereasonablytobeexpectedofadeviceofthatkind,havingregardtotheintendedpurposeandtheanticipateduseofthedevice.

5.

Thedevicesmustbedesigned,manufacturedandpackedinsuchawaythattheircharacteristicsandperformancesduringtheirintendedusewillnotbeadverselyaffectedduringtransportandstorage（temperature,humidity,etc.）takingintoaccounttheinstructionsandinformationprovidedbythemanufacturer.

B.

DESIGNANDMANUFACTURINGREQUIREMENTS

1.

ChemicalandPhysical

ThedevicesmustbedesignedandmanufacturedinsuchawayastoachievethecharacteristicsandperformancesreferredtoinSectionAonthe"GeneralRequirements".Particularattentionmustbepaidtothepossibilityofimpairmentofanalyticalperformanceduetoincompatibilitybetweenthematerialsandthespecimens（suchasbiologicaltissues,cells,bodyfluidsandmicro-organisms）intendedtobeusedwiththedevice,takingaccountofitsintendedpurpose.

Thedevicesmustbedesigned,manufacturedandpackedinsuchawayastoreduceasfaraspossibletheriskposedbyproductleakage,contaminantsandresiduestothepersonsinvolvedinthetransport,storageanduseofthedevices,takingaccountoftheintendedpurposeoftheproduct.

2.

Infectionandmicrobialcontamination

Thedevicesandtheirmanufacturingprocessesmustbedesignedinsuchawayastoeliminateorreduceasfaraspossibletheriskofinfectiontotheuserorotherpersons.Thedesignmustalloweasyhandlingand,wherenecessary,reduceasfaraspossiblecontaminationof,andleakagefrom,thedeviceduringuseand,inthecaseofspecimenreceptacles,theriskofcontaminationofthespecimen.Themanufacturingprocessesmustbeappropriateforthesepurposes.

Whereadeviceincorporatesbiologicalsubstances,therisksofinfectionmustbereducedasfaraspossiblebyselectingappropriatedonorsandappropriatesubstancesandbyusingappropriatevalidatedinactivation,conservation,testandcontrolprocedures.

Deviceslabelledeitheras‘STERILE’orashavingaspecialmicrobiologicalstatemustbedesigned,manufacturedandpackedinanappropriatepack,accordingtoproceduressuitableforensuringthattheyremainintheappropriatemicrobiologicalstateindicatedonthelabelwhenplacedonthemarket,underthestorageandtransportconditionsspecifiedbythemanufacturer,untiltheprotectivepackagingisdamagedoropened.

Deviceslabelledeitheras‘STERILE’orashavingaspecialmicrobiologicalstatemusthavebeenprocessedbyanappropriate,validatedmethod.

Packagingsystemsfordevicesotherthanthosereferredtoinsectionmustkeeptheproductwithoutdeteriorationatthelevelofcleanlinessindicatedbythemanufacturerand,ifthedevicesaretobesterilisedpriortouse,reduceasfaraspossibletheriskofmicrobialcontamination.

Stepsmustbetakentoreduceasfaraspossiblemicrobialcontaminationduringselectionandhandlingofrawmaterials,manufacture,storageanddistributionwheretheperformanceofthedevicecanbeadverselyaffectedbysuchcontamination.

Devicesintendedtobesterilized,mustbemanufacturedinappropriatelycontrolled.environmental）conditions.

Packagingsystemsfornon-steriledevicesmustkeeptheproductwithoutdeteriorationinthelevelofcleanlinessstipulatedand,ifthedevicesaretobesterilizedpriortouse,minimizetheriskofmicrobialcontamination;thepackagingsystemmustbesuitabletakingaccountofthemethodofsterilizationindicatedbythemanufacturer.

3

Manufacturingandenvironmentalproperties

Ifthedeviceisintendedforuseincombinationwithotherdevicesorequipment,thewholecombination,includingtheconnectionsystemmustbesafeandmustnotimpairthespecifiedperformancesofthedevices.Anyrestrictionsontheusemustbeindicatedonthelabelorintheinstructionsforuse.

Devicesmustbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletheriskslinkedtotheiruseinconjunctionwithmaterials,substancesandgaseswithwhichtheymaycomeintocontactduringnormalconditionsofuse

Devicesmustbedesignedandmanufacturedinsuchawayastoremoveorreduceasfaraspossible:

-theriskofinjurylinkedtotheirphysicalfeatures（inparticularaspectsofvolumexpressure,dimensionand,whereappropriate,ergonomicfeatures）,-riskslinkedtoreasonablyforeseeableexternalinfluences,suchasmagneticfields,externalelectricaleffects,electrostaticdischarge,pressure,humidity,temperatureorvariationsinpressureoraccelerationoraccidentalpenetrationofsubstancesintothedevice.

Devicesmustbedesignedandmanufacturedinsuchawayastoprovideanadequatelevelofintrinsicimmunityofelectromagneticdisturbancetoenablethemtooperateasintended.

Devicesmustbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletherisksoffireorexplosionduringnormaluseandinsinglefaultcondition.Particularattentionmustbepaidtodeviceswhoseintendeduseincludesexposuretooruseinassociationwithflammablesubstancesorsubstanceswhichcouldcausecombustion.

Devicesmustbedesignedandmanufacturedinsuchawayastofacilitatethemanagementofsafewastedisposal.

Themeasuring,monitoringordisplayscale（includingcolourchangeandothervisualindicators）mustbedesignedandmanufacturedinlinewithergonomicprinciples,takingaccountoftheintendedpurposeofthedevice.

4

Deviceswhichareinstrumentsorapparatuswithmeasuringfunction

Deviceswhichareinstrumentsorapparatushavingaprimaryanalyticalmeasuringfunctionmustbedesignedandmanufacturedinsuchawayastoprovideadequatestabilityandaccuracyofmeasurementwithinappropriateaccuracylimits,takingintoaccounttheintendedpurposeofthedeviceandofavailableandappropriatereferencemeasurementproceduresandmaterials.Theaccuracylimitshavetobespecifiedbythemanufacturer.

Whenvaluesareexpressednumerically,theymustbegiveninlegalunitsconformingtotheprovisionsofCouncilDirective80/181/EECof20December1979ontheapproximationofthelawsoftheMemberStatesrelatingtounitsofmeasurement.

5

Protectionagainstradiation

Devicesshallbedesigned,manufacturedandpackagedinsuchawaythatexposureofusersandotherpersonstotheemittedradiationisminimised.

Whendevicesareintendedtoemitpotentiallyhazardous,visibleand/orinvisibleradiation,theymustasfaraspossiblebe:

?

designedandmanufacturedinsuchawayastoensurethatthecharacteristicsandthequantityofradiationemittedcanbecontrolledand/oradjusted,?

fittedwithvisualdisplaysand/oraudiblewarningsofsuchemissions.

Theoperatinginstructionsfordevicesemittingradiationmustgivedetailedinformationastothenatureoftheemittedradiation,meansofprotectingtheuser,andonwaysofavoid