验证方案包装包括报告英文样本文档格式.docx
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验证方案包装包括报告英文样本文档格式.docx
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Date
Collectsigndept.
Collectionsign
Date
Catalogue
1.Purpose
2.Contextofinspection
3.Resultsanalysisandappraise
4.Finalapproval
5.Organizationofinspection
6.Dutyanddividethework
1.Inspectpurpose:
ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).
2.Inspectcontents
Thefirstpart:
theinspectionofsinglepacking.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsasfollowing:
1)PreliminarycontaminatedInspectionofsinglepacking:
2)Non-ventilateinspectionofsinglepacking:
3)Preventbacteriuminspectionofsinglepacking:
4)Assistanceto-leakageinspectionofsinglepacking:
5)Biologicalcompatibilityinspectionofsinglepacking:
6)Toxicityinspectionofsinglepacking
7)Labelsysteminspectionofsinglepacking
1)PreliminarycontaminatedInspectionofsinglepacking:
omnivorouslyholdingsamples10PCS(triplebags250mlwithlot0218,0219,0220)aftersterilization,themethodsofinspectionrefertoEN1174-1/2/3:
1996theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thefirstpart:
essencerequirementslist,theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise---thesecondpart:
instructionofapplication,theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thethirdpart:
theconfirmmethodinstructionofinspectiontechnical.
2)Non-ventilateinspectionofsinglepacking:
takeout5piecesaftersterilizationconvenientlywithlot021811,021812,and021813andsendtoinspectcenter.
AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods.
3)Preventbacteriuminspectionofsinglepacking:
takeout5piecesconvenientlyaftersterilizationwithlot021811,021812,and021813andsendtoinspectcenter.
4)Anti-leakageinspectionofsinglepacking:
takeout5piecesconvenientlywithlot021811,021812,and021813andsendtoinspectcenter.
WhenfilledtonominalcapacitywithwaterasspecifiedinISO3696andsealed,theplasticcontainershallnotdevelopleaksunderconditionsofcentrifugationat5000gat37℃for10min.Theplasticcontaineristhensqueezedbetweentwoplatestoaninternalpressureequivalentto50kPaaboveatmosphericpressureat(23+5)℃for10min.Noleakageisallowedonvisualinspection.
Note;
whentheplasticcontainerisfilledwithanticoagulantsolution,leakagemaybedetectedbypressingtheplasticcontaineragainstsheetsofbluelitmuspaperandobservingthedevelopmentofpinkspotsonthepaper.ThedetailinformationreferstoISO3826:
1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.
5)Biologicalcompatibilityinspectionofsinglepacking:
ThemethodsofexperimentsrefertoISO10993-1:
1997biologicalappraiseofmedicaldevicethefirstpart:
appraiseandtest.
6)Toxicityinspectionofsinglepacking:
takeout5piecesconvenientlyaftersterilizationwithlot021811,021812,and021813andsendtoinspectcenter.ThemethodofexperimentsreferstoISO3826:
7)Labelsysteminspectionofsinglepacking
Takeout5piecesconvenientlylabelstuckwithlot021811,021812,021813,inspectonebyoneaccordingtoEN980packageandsymbolofmedicalpolymerproductsincluding:
(1)Generaldemands
a)Thesymbolindicatedonpackageshouldbeinstructtoshipments,storage,tearingopenandusage
b)Thesymbolindicatedonpackageshouldbeclear,perspicuity,fastness,Itisforbiddentobrushofforslurintheprocessofsterilization,shipmentsandstorage.
c)Thesymbolofparliamentarypackingshouldbetypedontheoutersurfacebutnotexceptforconsideringthatremovingcaninfluenceonthequalityinthepackage.
(2)Thegeneralinformationonthesinglepacking
a)Productsname.styleorspecification
b)Themanufacturename,addressandbrands
c)Productionlotordate:
d)“non-sterilize”lettersand/thenon-sterilizesymbolofdrawing“destroyedafterusing”letters:
e)Ifthesinglepackingisbroken,donotusetheproducts.“Packagebrokennottouse”mustbeindicated.
f)Singleuseinstruction/symboldesign:
g)Expirydate:
Thesecondpart----over-packageinspection
1.Inspectpurpose:
.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourpackingmaterial,wecarryouttheinspectionsasfollowing:
1)Non-ventilateinspectionofsinglepacking:
2)Preventbacteriuminspectionofsinglepacking:
3)Agglutinateofsealinspectionofsinglepacking:
2.Contentsofinspection:
1)Non-ventilateinspectionofover-package:
Takeofftheouterpacking,andtakeout5piecesconvenientlywithlotnumber0111,0120,0127andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,thepersonwhoconcerningwillcarryoutNon-ventilateinspectionofsinglepacking..
2)Preventbacteriuminspectionofover-package:
thegeneralrequirementsandinspectmethods,thepersonwhoconcerningwillcarryoutpreventbacteriuminspectionofsinglepacking.
4)Agglutinateofsealinspectionofover-package:
accordingtotherequirements,puttheproductsintosinglepacking,settingtheparameteronthesealmachine,eachgroupscanseal5pieceswithlotnumber0111,0120,0127andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,thepersonwhoconcerningwillcarryoutagglutinateofsealinspectionofsinglepacking:
GroupsParameter
Sealtemperature
Conveyspeed
1
200℃
High
2
210℃
3
220℃
High
.
3.Thefinalapproval:
Theabove-mentionedexperimentswerecheckedandapprovedbyinspectiongroupswithappraiseandanalysis,theeligibilitydocumentswillhandovertodepartmentsforputtingintoapplication.
3.Inspectionorganization
4.1Inspectionprincipal:
ChengYunliang
Workshopmember:
ZhangYanhongDongLujingDouXiaojie
Manufacturedepartments’member:
TianXuefeiZhaoZhendongLiXiouyingZhangCuiyan
4.2Dutyanddividethework
Workshop:
chargetherecordsofprocessofproduction;
strictlycontroltheprocessofproduction
Manufacturedepartments:
harmonizeanddocorrespondentdocumentsintheprocessofinspection.
5.Worksschedule:
Invision,theworkwillbefinishedinMar,.
XXXGroupCorp.
Packinginspectreports
1.Summarize
2.Packinginspectionproject
3.Contentsofinspectioninsinglepackage
4.Contentsofinspectioninover-package
5.Conclusionofinspection
6.Attachmentdocuments
1.Summarize
ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.Mid-packingusuallyareadoptedaluminumplastic.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC)andBP/CX-21-07,AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).
2.Inspectproject
TheinspectprojectiscompiledbyTechnologyDeptwithcollectsignedbyseveralofdepartments,andauthorizedbyadminister.
3.Inspectcarryingintoexecution
Accordingtopackinginspectproject,wecomposedinspectiongroupstoinspectitemsasfollowing:
3.1PreliminarycontaminatedInspectionofsinglepacking:
Descriptionandtype:
250mltriplebags,lotnumber0218,0219,and0220:
Inspectreference:
GB15980-1995thedispo
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