英文CE.docx
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英文CE.docx
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英文CE
CONTROLLEDTATE
CEFILESLIST
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CEFILESLIST
Chapter
SerialNo.
Title
1
CEFILESLIST
2
COMPANYINTRODUCTION
3
STATEMENTCONCERNINGAUTHORIZEDREPRESENTATIVEESTABLISHEDWITHINEUROPEANCOMMUNITY
4
PRODUCTSDESCRIPTION
5
RISKANALYSIS
6
STATEMENTOFCONFORMITY
7
CHECKOFBASICSAFETYPOINTS
8
CONFORMANCETOSTANDARDS
9
MARKETFEEDBACKORCUSTOMERCOMPLAINTANALYSISREPORT-VIGILANCESYSTEM
10
LABELINGANDINSTRUCTIONSFORUSE
11
SPECIFICATIONOFPRODUCTS
12
REVIEWDOCUMENTSFORMANUFACTUREANDTEST
13
SPECIALPROCEDURES
14
PACKAGINGMATERIALS
15
CLINICALTRIALSREPORT
CONTROLLEDSTATE
COMPANYINTRODUCTION
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COMPANYINTRODUCTION
CONTROLLEDSTATE
STATEMENTCONCERNINGAUTHORIZEDREPRESENTATIVEESTABLISHEDWITHINEUROPEANCOMMUNITY
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StatementconcerningAuthorizedRepresentative
EstablishedwithinEuropeanCommunity
WehavenotsoldproductsinEuropeandnotappointedAuthorizedRepresentativeEstablishedwithinEuropeanCommunity.WewillnominateDistributorandAuthorizedRepresentativeEstablishedwithinEuropeanCommunityandinformNotifiedBodybeforeourproductswereexportedtoEurope.
Postsignaturedate
CONTROLLEDSTATE
PRODUCTSDESCRIPTION
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PRODUCTSDESCRIPTION
CONTROLLEDSTATE
RISKANALYSIS
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1.Foreword
2.Indications
3.MechanismofAction
4.Description
1).Appearance
2).Amountofproduct
5.TypeandSize
Type
Size
powder
ointment
6.Questionsthatcanbeusedtoidentityproductcharacteristicsthatcouldimpactonsafety:
1).Whatistheintendeduse/intendedpurposeandhowisthemedicaldevicetobeused?
2.)Isthemedicaldeviceintendedtocontactthepatientorotherpersons?
3).Whatmaterialsand/orcomponentsareincorporatedinthemedicaldeviceorareusedwith,orareincontactwith,themedicaldevice?
4).Isenergydeliveredtoand/orextractedfromthepatient?
5).Aresubstancesdeliveredtoand/orextractedfromthepatient?
6).Arebiologicalmaterialsprocessedbythemedicaldeviceforsubsequentre-use?
NO.
7).Isthemedicaldevicesuppliedsterileorintendedtobesterilizedbytheuser,orareothermicrobiologicalcontrolsapplicable?
8).Isthemedicaldeviceintendedtoberoutinelycleanedanddisinfectedbytheuser?
9).Isthemedicaldeviceintendedtomodifythepatientenvironment?
No
10).Aremeasurementstaken?
No
11).Isthemedicaldeviceinterpretative?
No
12).Isthemedicaldeviceintendedforuseinconjunctionwithmedicinesorothermedicaltechnologies?
13).Arethereunwantedoutputsofenergyorsubstances?
No
14).Isthemedicaldevicesusceptibletoenvironmentalinfluences?
No.
15).Doesthemedicaldeviceinfluencetheenvironment?
No.
16).Arethereessentialconsumablesoraccessoriesassociatedwiththemedicaldevice?
17).Ismaintenanceand/orcalibrationnecessary?
No.
18).Doesthemedicaldevicecontainsoftware?
No.
19).Doesthemedicaldevicehavearestrictedshelf-life?
20).Arethereanydelayedand/orlong-termuseeffects?
No.
21).Towhatmechanicalforceswillthemedicaldevicebesubjected?
22).Whatdeterminesthelifetimeofthemedicaldevice?
23).Isthemedicaldeviceintendedforsingleuse?
24).Issafedecommissioningordisposalofthemedicaldevicenecessary?
No.
25).Doesinstallationorusesofthemedicaldevicerequirespecialtraining?
No.
26).Willnewmanufacturingprocessesneedtobeestablishedorintroduced?
No.
27).Issuccessfulapplicationofthemedicaldevicecriticallydependentonhumanfactorssuchastheuserinterface?
28).Isthemedicaldeviceintendedtobemobileorportable?
7.Identificationofpotentialhazards
Table1Overviewoftheriskmanagementprocess
No.
Normalcondition
Fault
condition
Possiblecauses
Possibleconsequences
8.Definitionofquantitativeandqualitativeriskestimation:
Theprobabilitiesofoccurrence(P)andthedegreeofseverity(S)wasdefinedaccordingFailuremodeandexaminationanalysis(FMEA).TheproductofPandSwasusedtoidentifyrisklevelofhazard
a)Theprobabilitiesofoccurrence(P)rangedfrom1to6.
Table2PExamination
Level
Probabilities/year
PExamination
frequent
>1
6
probable
1~10-1
5
occasional
10-1~10-2
4
remote
10-2~10-4
3
improbable
10-4~10-6
2
incredible
<10-6
1
2.Thedegreeofseverity(S)rangedfrom1to4.
Table3SExamination
level
severity
SExamination
catastrophic
4
serious
3
critical
2
marginal
1
3.
Riskrankmatrix
Table4riskrankmatrix
severity
Probabilities
S4
catastrophic
S3
serious
S2
critical
S1
marginal
P6frequent
high
24
high
18
medium
12
low
6
P5probable
high
20
medium
15
low
10
slight
5
P4occasional
medium
16
medium
12
low
8
slight
4
P3remote
medium
12
low
9
slight
6
slight
3
P2improbable
low
8
slight
6
slight
4
slight
2
P1incredible
slight
4
slight
3
slight
2
slight
1
4.Risk/benefitanalysis
Table5Risk/benefitanalysis
Level
Hazardidentification
Riskregion
1~6
7~11
12~17
18~24
5.Riskevaluation,extermination,acceptablelevel,reductionmeasuresandothergeneratedhazards
Table6Riskrevaluation,acceptation,reductionmeasures
andgeneratedrisk
Hazards
Possiblecauses
Severity
Before/after
Probabilities
Level
Measures
1)
Note1:
allrisksassociatedwithproductinnormalandfaultconditionhavebeenestimated.
Note2
九、Conclusionofriskanalysis
CONTROLLEDSTATE
STATEMENTOFCONFORMITY
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STATEMENTOFCONFORMITY
Manufacturer:
Address:
AuthorizedrepresentativeestablishedwithinEuropeancommunity:
/
Address:
/
Productname:
Type:
Typeofmedicaldevices:
Westated:
Directives
Directivesweconformedto:
COMMISSIONDIRECTIVE93/42/EEC(1993.7.14)relatedtoDirectiveMDD93/42/EECconcerningmedicaldevices
Standardsweconformedto:
ISO9001、EN1441、ISO13485、EN554、EN550、EN980、EN724、EN868-1、EN1174、EN14644-1、MDD(93/42/EEC)。
No.andcodeofNotifiedBody:
CertificateNo.:
Date:
issuedate:
Address:
CONTROLLEDSTATE
CHECKOFBASICSAFETYPOINTS
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Basicrequirements
Suitable
(Y/N)
Standards
Reportsordocuments
Conformityofcompany
1.Thedevicesmustbedesignedandmanufacturedinsuchawaythat,whenuserundertheconditionsandforthepurposesintended,theywillnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersonsprovidedthatanyriskswhichmaybeassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofhealthandsafety.
Y
ISO14971-1
SeeSHLG/CE.JS-05
RISKANALYSIS
Meetthebasicrequirements
2.Thesolutionsadoptedbythemanufacturerforthedesignand
constructionofthedevicesmustconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart
inselectingthemostappreciatesolutions,themanufacturermustapplythefollowingprinciplesinthefollowingorder:
__eliminateorreducerisksasfarpossible(inherentlysafedesignandconstruction)
__whereappropriatetakeadequateprotectionmeasuresincludingalarmsifnecessary,inrelationtorisksthatcannotbeeliminated.
__informusersoftheresidualrisksduetoanyshortcomingsoftheprotectionmeasuresadopted.
Y
ISO14971-1
SeeSHLG/CE.JS-05
RISKANALYSIS
Meetthebasicrequirements
3.Thedevicesmustachievetheperformancesintendedbythemanufacturerandbedesigned,manufacturedandpackagedinsuchawaythattheyaresuitableforoneormoreofthefunctionsreferredtoinArticle1(a)asspecifiedbythemanufacturer.
N
4.ThecharacteristicsandperformancereferredtoinSelection1,2and3mustnottobeadverselyaffectedtosuchadegreethattheclinicalconditionsandsafetyofthepatientsand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedeviceasindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuse.
N
5.Thedevicesmustbedesigned,manufacturedandpackedinsuchawaythattheircharacteristicsandperformancesduringtheirintendedusewillnotbeadverselyaffectedduringtransportandstoragetakingaccountoftheinstructionsandinformationprovidedbythemanufacturer.
Y
EN868-1
EN980
SeeSHLG/CE.JS-15
REPORTOFPACKAGINGMATERIALS
Meetthebasicrequirements
6.Anyundesirablesideeffectmustconstituteanacceptableriskwhenweighedagainsttheperformanceintended.
Y
ISO14971-1
SeeSHLG/CE.JS-05
RISKANALYSIS
Meetthebasicrequirements
7.Chemical,phsicalandbiologicalproperties
7.1Thedevicesmustbedesignedandmanufacturedinsuchawayastoguaranteethecharacteris
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