第1页共11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11页更多企业学院：《中小企业管理全能版》183套讲座+89700份资料《总经理、高层管理》49套讲座+16388份资料《中层管理学院》46套讲座+6020份资料《国学智慧、易经》46套讲座《人力资源学院》56套讲座+27123份资料《各阶段员工培训学院》77套讲座+324份资料《员工管理企业学院》67套讲座+8720份资料《工厂生产管理学院》52套讲座+13920份资料《财务管理学院》53套讲座+17945份资料《销售经理学院》56套讲座+14350份资料《销售人员培训学院》72套讲座+4879份资料XXXGroupCorp.MedicalPolymerproductsCo.,LTD第2页共11页第1页共11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11页PackinginspectprojectName:theartsandcraftsinspectionofpackingDocumentsserialNo:VP-002draftsmanexamineandapproveratifierSignDateCollectsigndept.CollectionsignDateCatalogue1.Purpose第3页共11页第2页共11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11页2.Contextofinspection3.Resultsanalysisandappraise4.Finalapproval5.Organizationofinspection6.Dutyanddividethework第4页共11页第3页共11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11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.3)Preventbacteriuminspectionofsinglepacking:takeout5piecesconvenientlyaftersterilizationwithlot2003021811,2003021812,and2003021813andsendtoinspectcenter.Accordingtotherequirements...
