第1页共10页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共10页XXXGroupCorp.MedicalPolymerproductsCo.,LTDPackinginspectprojectName:theartsandcraftsinspectionofpackingDocumentsserialNo:VP-002draftsmanexamineandapproveratifierSignDateCollectsigndept.CollectionsignDate第2页共10页第1页共10页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共10页Catalogue1.Purpose2.Contextofinspection3.Resultsanalysisandappraise4.Finalapproval5.Organizationofinspection6.Dutyanddividethework第3页共10页第2页共10页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共10页1.Inspectpurpose:ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction(MDD93/42/EEC),AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods,withregardtoourinnerpacking,wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction(MDD93/42/EEC).2.InspectcontentsThefirstpart: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)Toxicityinspectionofsinglepacking7)Labelsysteminspectionofsinglepacking1)PreliminarycontaminatedInspectionofsinglepacking:omnivorouslyholdingsamples10PCS(triplebags250mlwithlot20030218,20030219,20030220)aftersterilization,themethodsofinspectionrefertoEN1174-1/2/3:1996theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thefirstpart:essencerequirementslist,theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise---thesecondpart:instructionofapplication,theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thethirdpart:theconfirmmethodinstructionofinspectiontechnical.2)Non-ventilateinspectionofsinglepacking:takeout5piecesaftersterilizationconvenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods.第4页共10页第3页共10页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第4页共10页3)Preventbacteriuminspectionofsinglepacking:takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts:thegeneralrequirementsandinspectmethods.4)Anti-leakageinspectionofsinglepacking:takeout5piecesconvenientlywithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.WhenfilledtonominalcapacitywithwaterasspecifiedinISO3696andsealed,theplasticcontainershallnotdevelopleaksunderconditionsofcentrifugationat5000gat37℃for10min.Theplasticcontaineris...
