欧盟MDR法规下医用口罩CE技术文档.docx

欧盟MDR法规下医用口罩CE技术文档.docx

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欧盟MDR法规下医用口罩CE技术文档

*******Co.,Ltd.

DisposableMedicalMask

CETechnicalDocument

Doc.No：

BN/CE01Ver.：

A/0

DraftedBy:

AuditedBy:

ApprovedBy:

IssueDate:

2020-12-01EffectiveDate:

2020-12-01

Content

1.ECDeclarationofConformity

Manufacturer:

whosesingleAuthorizedEU-Representative:

Name:

*******

Add:

******

TEL：

*******

Name:

*****

Add:

*****

Tel:

******

We,themanufacturer,herewithdeclarethattheproducts

DisposableMedicalMask

meettheprovisionsofMDR2017/745whichapplytothem.

ThemedicaldevicehasbeenassignedtoclassIaccordingtoRule1,AnnexVIII,ChapterIIIofEUMedicalDeviceRegulation（EU）2017/745.Itbearsthemark

followingtheprocedurerelatingtotheECDeclarationofConformitysetoutinAnnexIIofMDR2017/745.

Itisconfirmedthatasampleoftheproducthasbeentestedandfoundinconformitywithbelow

TestStandard:

EN14683：

2019Medicalfacemasks–Requirementsandtestmethods

Classifications:

TypeⅡ

Theabovementioneddeclarationofconformityisexclusivelyundertheresponsibilityof

Company:

*******

Place,dateLegallybindingsignature,Funct

2.ProductIntroduction

2.1Introductionofthecompany

WuhanBaonuoPlasticProductsCo.,Ltd.isacompanythatmainlyproducesdisposablepaper,plasticandnon-wovenproducts.ThecompanyislocatedatBlockA,No.8NewMetropolisIndustrialPark,HannanDistrict,WuhanCity,HubeiProvince.Theexistingfixedassetsaremorethan10millionyuan,thecompanycoversanareaof4acres,andtheproductionworkshopis2500squaremeters.Thecompany'sproductsaresoldtomorethanadozencountriesandregionssuchastheUnitedStates,Europe,SoutheastAsia,Australia,andaredeeplyfavoredbyusers.Thecompany'sproductsincludedisposablenon-wovenproducts,plasticproducts,paperproducts（roundcaps,stripedmushroomcaps,protectivecaps,papercaps,masks,isolationgowns,protectiveclothing,laboratoryclothes,aprons,sheets,sleeves,shoecovers,Wipes,etc.）.Thecompany'sproductsaresuitableforthedifferentneedsofallwalksoflife,suchaslaborprotectionpurposes,electronicfactories,foodindustry,beautycare,decorationengineering,hardwareandchemicalindustry,cleaninganddailylife,etc.

2.2Productdescription

Disposablemedicalmaskisespeciallydesignedforthemedicalpersonnelandvisitationpersonnelusinginhospital.Theemployedmaterialismostlywater-stabbednon-wovenfabricandSMSthreelayerscompoundnon-wovenfabric.Bindingandchemicalsubstanceandbondarenotusedinthesetwomaterials.Thesematerialshavemanygoodproperties,suchassoft,clean,goodfiltrationanduniformity,theyarenotsensitivetohumanbeings,difficulttofluff,theydon'thaveanypeculiarsmell,othermatterandprimarycolor.Inaword,theyaredesirablesanitationmaterial.

TheDisposablemedicalmaskusingthetwomaterialshavepropertiessuchas:

1）Theyhaveenoughstrengthandgoodwaterproof.Theyofferacrediblebarrierformedicalpersonnelandvisitationpersonnelandcaneffectivelyblockliquidsplashwhichisoftentakenplaceinhospital.

2）Theyhavelowrateoffallingcrumbs,donothavenoiseinabrasionanddon'tglisteninlamp;theycanbedecomposed,anddon'thaveanypollutiontoenvironment.

Thematerialsoffersafetyandcomfortfordoctorandnursebecauseofsoftnessandwaterproof.Inthemeantime,becausetheDisposablemedicalmaskhavegoodperformanceofresistancebacteria，theoozyliquidinhospitalcanbeeffectivelyobstructedtopreventthebacteriainfection.

2.3Intendeduse

Disposablemedicalmaskisespeciallydesignedforthemedicalsituation,cleanroom,andvisitors,canbeobstructedeffectivelytopreventthebacteriainfection.

2.4Contraindicationofusingproduct

a）TheDisposablemedicalmaskcanbeusedonlyonceandshouldbeusedimmediatelyafteropeningthepackageanddestroyedafterwards;Strictlyprohibitusingthemifthepackageisdamaged;

b）Theproductcannotbeusedduetomildewordamp.Theyshouldbelocatedattheplacewhereisabstainedfromhightemperatureandhighhumidity,andfromcausticgases,andhavegooddrynessandventilation.

c）Everytestitemmustmeetwithstandardbeforeusingthem.

d）Theperiodofvalidityis3yearsfromthedateofmanufacture,mustusetheminthisperiod.

2.5DefinitionandClassificationofProduct

TheproductisdefinedandclassifiedaccordingtothepredictedpurposeandMDR2017/745classificationrule.

2.5.1Definitionofproduct

Onthebasesoftheexpectedpurposeandclassificationrule,thedisposablemedicalmaskmustbe:

a）Theinstrumentusedinashortperiod;

b）Theinstrumentwithoutsource

c）Thenon-invasivemedicalinstrument;

d）Theinstrumentimmunefrombacteria.

2.5.2Classificationofproduct

AccordingtoMDR2017/745,thedisposablemedicalmaskwhichcomeintocontactwithinjuredskinmustaccordwithRule1;ifitisemployedasmechanicalbarrier,forcompressionorabsorptionofexudation.Ifitisusedastheproductofsterilization,thentheinstrumentbelongstoclass1*.

2.1.Approachofapplication

AccordingtoMDR2017/745evaluationproceduresandcertificateconfirmation,theapproachofapplicationofproductconformingassessmentisAnnexⅤ（ENISO13485:

2016）＋AnnexII.

2.2.ManufacturerofapplicationandrepresentativeauthorizedbyEEC

Manufacturer:

Name:

*****

Add:

******

TEL：

*****

EuropeanRepresentative:

Name:

*****

Add:

*****

Tel:

*****

3.Listofessentialrequirements

3.1.ListofENandISOStandards

No.

Documentnumber

Versionnumber

NameofDocument

1.

ENISO13485

2016

Medicaldevices.Qualitymanagementsystems.Requirementsforregulatorypurposes

2.

MDR（2017/745/EU）

2017

MedicalDevicesregulation

3.

ENISO14971

2019

medicaldevices—applicationofriskmanagementtomedicaldevices

4.

ENISO10993-1

2018

Biologicalevaluationofmedicaldevices-Part1:

Evaluationandtestingwithinariskmanagementprocess

5.

ENISO10993-5

2009

Biologicalevaluationofmedicaldevices-Part5:

Testsforinvitrocytotoxicity

6.

ENISO10993-10

2013

Biologicalevaluationofmedicaldevices-Part10:

Testsforirritationandskinsensitization

7.

EN1041

2008

Terminology,SymbolsandInformationwithMedicalDevices;Informationsuppliedbythemanufacturerwithmedicaldevices

8.

EN14683

2014

Surgicalmasks-Requirementsandtestmethods

9.

ENISO15223-1

2016

medicaldevices-symbolstobeusedwithmedicaldevicelabels,labellingandinformationtobesupplied-part1:

generalrequirements

10.

EN62366-1

2015

Medicaldevices-Part1:

Applicationofusabilityengineeringtomedicaldevices

3.2.Listofessentialrequirements:

TherequirementofMedicalDeviceRegulation2017/745

A/NA

Standards,otherdirectivesandotherrulesappliedbymanufacturer

生产者引用的标准,其它指令或规则

Documentation（testreports,protocols,literatureorreasonfornoapplicability）

支持性文件（测试报告,条例,文献或不适用的理由）

Requirementsfulfilled

（tobefilledinby

NotifiedBody）

要求满足

（由公告机构填写）

Ok/Fail

符合/不符合

I.

GeneralRequirements

总要求

1.

Devicesshallachievetheperformanceintendedbytheirmanufacturerandshallbedesignedandmanufacturedinsuchawaythat,duringnormalconditionsofuse,theyaresuitablefortheirintendedpurpose.Theyshallbesafeandeffectiveandshallnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybe

associatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety,takingintoaccountthegenerallyacknowledgedstateoftheart.

A

ENISO15223‐1:

2016

ENISO14971:

2019

ISO10993‐1:

2018

ENISO10993‐5:

2009

ENISO10993‐10:

2013

Label

RiskManagementReport

BiocompatibilityTestReport:

SDWH-M201502191-1,

SDWH-M201502191-2,

SDWH-M201502191-3

2.

TherequirementinthisAnnextoreducerisksasfaraspossiblemeansthereductionofrisksasfaraspossiblewithoutadverselyaffectingthebenefit‐riskratio.

A

ENISO14971:

2019

RiskManagementReport

3.

Manufacturersshallestablish,implement,documentandmaintainariskmanagementsystem.

Riskmanagementshallbeunderstoodasacontinuousiterativeprocessthroughouttheentirelifecycleofadevice,requiringregularsystematicupdating.Incarryingoutriskmanagementmanufacturersshall:

（a）establishanddocumentariskmanagementplanforeachdevice;

（b）identifyandanalysetheknownandforeseeablehazardsassociatedwitheachdevice;

（c）estimateandevaluatetherisksassociatedwith,andoccurringduring,theintendeduseandduringreasonablyforeseeablemisuse;

（d）eliminateorcontroltherisksreferredtoinpoint（c）inaccordancewiththerequirementsofSection4;

（e）evaluatetheimpactofinformationfromtheproductionphaseand,inparticular,fromthepost‐marketsurveillancesystem,onhazardsandthefrequencyofoccurrencethereof,onestimatesoftheirassociatedrisks,aswellasontheoverallrisk,benefit‐riskratioandriskacceptability;and

（f）basedontheevaluationoftheimpactoftheinformationreferredtoinpoint（e）,ifnecessaryamendcontrolmeasuresinlinewiththerequirementsofSection4.

A

ENISO14971:

2019

RiskManagementReport:

4.

Riskcontrolmeasuresadoptedbymanufacturersforthedesignandmanufactureofthedevicesshallconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart.Toreducerisks,Manufacturersshallmanageriskssothattheresidualriskassociatedwitheachhazardaswel