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1、XXX Group Corp.Medical Polymer products Co.，LTD Packing inspect 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 apprais
2、e4. Final approval5. Organization of inspection6. Duty and divide 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 E
3、uropean CommunityMedical Device instruction (MDD93/42/EEC),According 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 o
4、f measuring up the requirements of medical device instruction(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 sterili
5、zed packing material and system-the first parts：the general 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 inspecti
6、on of single packing:4) Assistance to-leakage inspection 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
7、 10 PCS( triple bags 250ml with lot 0218,0219,0220) 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- ani
8、malcule contaminated appraise-the second 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 st
9、erilization conveniently with lot 021811，021812，and 021813 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 o
10、ut 5 pieces conveniently after sterilization with lot 021811，021812，and 021813 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
11、 packing：take out 5 pieces conveniently with lot 021811，021812，and 021813 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. The plastic c
12、ontainer 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 pressing the plastic c
13、ontainer 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 pieces convenie
14、ntly after sterilization with lot 021811，021812，and 021813 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
15、 with lot 021811，021812，and 021813 and send to inspect center. The method of experiments refers to ISO3826:1993 plastic collapsible containers for human blood and blood components.7) Label system inspection of single packingTake out 5 pieces conveniently label stuck with lot 021811，021812，021813，inspect one by one according to EN980 package and symbol of medical polymer products including:(1) General demandsa) The symbol indicated on package should be instruct to shipments，storage，tearing open and usageb) The symbol indicated on
