验证方案英文.docx
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验证方案英文.docx
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验证方案英文
XXXGroupCorp.
MedicalPolymerproductsCo.,LTD
Packinginspectproject
Name:
theartsandcraftsinspectionofpacking
DocumentsserialNo:
VP-002
draftsman
examineandapprove
ratifier
Sign
Date
Collectsigndept.
Collectionsign
Date
Catalogue
1.Purpose
2.Contextofinspection
3.Resultsanalysisandappraise
4.Finalapproval
5.Organizationofinspection
6.Dutyanddividethework
1.Inspectpurpose:
ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunit—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).
2.Inspectcontents
Thefirstpart:
theinspectionofsinglepacking.BasedontherequirementsfromEuropean
Community—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsasfollowing:
1)PreliminarycontaminatedInspectionofsinglepacking:
2)Non-ventilateinspectionofsinglepacking:
3)Preventbacteriuminspectionofsinglepacking:
4)Assistaneeto-leakageinspectionofsinglepacking:
5)Biologicalcompatibilityinspectionofsinglepacking:
6)Toxicityinspectionofsinglepacking
7)Labelsysteminspectionofsinglepacking
1)PreliminarycontaminatedInspectionofsinglepacking:
omnivorouslyholdingsamples10PCS(triplebags250mlwithlot20030218,20030219,20030220)aftersterilization,themethodsofinspectionrefertoEN1174-1/2/3:
1996theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thefirstpart:
esseneerequirementslist,theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise---thesecondpart:
instructionof即plication,theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thethirdpart:
theconfirmmethodinstructionofinspectiontechnical.
2)Non-ventilateinspectionofsinglepacking:
takeout5piecesaftersterilization
convenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods.
3)Preventbacteriuminspectionofsinglepacking:
takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:
thegeneralrequirementsandinspectmethods.
4)Anti-leakageinspectionofsinglepacking:
takeout5piecesconvenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.
WhenfilledtonominalcapacitywithwaterasspecifiedinISO3696andsealed,theplasticcontainershallnotdevelopleaksunderconditionsofcentrifugationat5000gat37°Cfor10min.Theplasticcontaineristhensqueezedbetweentwoplatestoaninternalpressureequivalentto50kPaaboveatmosphericpressureat(23+5)Cfor10min.Noleakageisallowedonvisualinspection.
Note;whentheplasticcontainerisfilledwithanticoagulantsolution,leakagemaybedetectedbypressingtheplasticcontaineragainstsheetsofbluelitmuspaperandobservingthe
developmentofpinkspotsonthepaper.ThedetailinformationreferstoISO3826:
1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.
5)Biologicalcompatibilityinspectionofsinglepacking:
takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.ThemethodsofexperimentsrefertoISO10993-1:
1997biologicalappraiseofmedicaldevicethefirstpart:
appraiseandtest.
6)Toxicityinspectionofsinglepacking:
takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.ThemethodofexperimentsreferstoISO3826:
1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.
7)Labelsysteminspectionofsinglepacking
Takeout5piecesconvenientlylabelstuckwithlot2003021811,2003021812,2003021813,inspectonebyoneaccordingtoEN980packageandsymbolofmedicalpolymerproductsincluding:
(1)Generaldemands
a)Thesymbol
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