验证方案(包装包括报告)(英文)

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1、XXXGroupCorp.MedicalPolymerproductsCo.,LTDPackinginspectprojectName:theartsandcraftsinspectionofpackingDocumentsserialNo:VP-002draftsmanexamineandapproveratifierSignDateCollectsigndept.CollectionsignDateCatalogue1.Purpose2.Contextofinspection3.Resultsanalysisandappraise4.Finalapproval5.Organiza

2、tionofinspection6.DutyanddividetheworkLInspectpurpose:ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunity一MedicalDeviceinstruction(MDD93/42/EEC),Accordingtot

3、herequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods，withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).2.InspectcontentsThefirstpar

4、t:theinspectionofsinglepacking.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC)，AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem——thefirstparts:thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryoutth

5、einspectionsasfollowing:1)PreliminarycontaminatedInspectionofsinglepacking:2)Non-ventilateinspectionofsinglepacking:3)Preventbacteriuminspectionofsinglepacking:4)Assistanceto-leakageinspectionofsinglepacking:5)Biologicalcompatibilityinspectionofsinglepacking:6)Toxicityinspectionofsinglepacking7

6、)LabelsysteminspectionofsinglepackingPreliminarycontaminatedInspectionofsinglepacking:omnivorouslyholdingsamples10PCS(triplebags250mlwithlot20030218,20030219,20030220)aftersterilization,themethodsofinspectionrefertoEN1174-1/2/3:1996theappraiseofsterilizationofmedicaldevice-animalculequantityinp

7、roducts---thefirstpart:essencerequirementslist,theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise—thesecondpart:instructionofapplication,theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts-