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1、n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XXX Group Corp.Medical Polymer products Co., LTD Packing inspec
2、t projectName: the arts and crafts inspection of packingDocuments serial No: VP-002draftsmanexamine and approveratifierSignDateCollect sign dept.Collection sign Date Catalogue1. Purpose2. Context of inspection3. Results analysis and appraise4. Final approval5. Organization of inspection6. Duty and d
3、ivide the work1. Inspect purpose: The disposable Plastic Blood bags made by us are packed inner package with PVC and over-package with high temperature co-ex plastic bags which are made from PP-PET material. Based on the requirements from European CommunityMedical Device instruction (MDD93/42/EEC),A
4、ccording to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods, with regard to our inner packing, we carry out the inspections in order to approve of measuring up the requirements of medical device instruc
5、tion(MDD93/42/EEC).2. Inspect contentsThe first part: the inspection of single packing. Based on the requirements from European CommunityMedical Device instruction (MDD93/42/EEC), According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the ge
6、neral requirements and inspect methods, with regard to our inner packing, we carry out the inspections as following:1) Preliminary contaminated Inspection of single packing:2) Non-ventilate inspection of single packing:3) Prevent bacterium inspection of single packing:4) Assistance to-leakage inspec
7、tion of single packing:5) Biological compatibility inspection of single packing:6) Toxicity inspection of single packing7) Label system inspection of single packing1)Preliminary contaminated Inspection of single packing: omnivorously holding samples 10 PCS( triple bags 250ml with lot 20030218,200302
8、19,20030220) after sterilization, the methods of inspection refer to EN1174-1/2/3:1996 the appraise of sterilization of medical device- animalcule quantity in products -the first part: essence requirements list, the appraise of sterilization of medical device- animalcule contaminated appraise-the se
9、cond part: instruction of application, the appraise of sterilization of medical device- animalcule quantity in products -the third part: the confirm method instruction of inspection technical .2) Non-ventilate inspection of single packing: take out 5 pieces after sterilization conveniently with lot
10、2003021811, 2003021812, and 2003021813 and send to inspect center.According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods.3) Prevent bacterium inspection of single packing: take out 5 pieces conven
11、iently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center.According to the requirements from EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods.4) Anti-leakage inspection of single pa
12、cking: take out 5 pieces conveniently with lot 2003021811, 2003021812, and 2003021813 and send to inspect center.When filled to nominal capacity with water as specified in ISO3696 and sealed, the plastic container shall not develop leaks under conditions of centrifugation at 5000g at 37 for 10 min.
13、The plastic container is then squeezed between two plates to an internal pressure equivalent to 50kPa above atmospheric pressure at (23+5) for 10 min. No leakage is allowed on visual inspection.Note; when the plastic container is filled with anticoagulant solution, leakage may be detected by pressin
14、g the plastic container against sheets of blue litmus paper and observing the development of pink spots on the paper. The detail information refers to ISO3826:1993 plastic collapsible containers for human blood and blood components.5) Biological compatibility inspection of single packing: take out 5
15、 pieces conveniently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center.The methods of experiments refer to ISO10993-1:1997 biological appraise of medical device the first part: appraise and test.6) Toxicity inspection of single packing: take out 5 pieces conveniently after sterilization with lot 2003021811, 2003021812, and 2003021813 and send to inspect center. The method of experiments ref
