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1、XXX Group Corp. Medical Polymer products Co., LTD Packing inspect project Name: the arts and crafts inspection of packing Documents serial No: VP-002 draftsman examine and approve ratifier Sign Date Collect sign dept. Collection sign Date Catalogue 1.Purpose 2.Context of inspection 3.Results analysi
2、s and appraise 4. Final approval 5. Organization of inspection 6. Duty and divide the work 1. 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 re
3、quirements from European Community Medical 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
4、in order to approve of measuring up the requirements of medical device instruction(MDD93/42/EEC). 2.Inspect contents The 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
5、-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 as following: 1) Preliminary contaminated Inspection of single packing: 2) Non-ventilate inspection of single packing
6、: 3) Prevent bacterium inspection of single packing: 4) Assistance to-leakage inspection of single packing: 5) Biological compatibility inspection of single packing: 6) Toxicity inspection of single packing 7) Label system inspection of single packing 1)Preliminary contaminated Inspection of single
7、packing: omnivorously holding samples 10 PCS( triple bags 250ml with lot 20030218,20030219,20030220) 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, t
8、he appraise of sterilization of medical device- animalcule 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 insp
9、ection of single packing: take out 5 pieces after sterilization conveniently 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 insp
10、ect methods. 3) Prevent bacterium inspection of single packing: take out 5 pieces conveniently 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 pa
11、rts: the general requirements and inspect methods. 4) Anti-leakage inspection of single packing: 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 conta
12、iner shall not develop leaks under conditions of centrifugation at 5000g at 37 for 10 min. 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
13、 plastic container is filled with anticoagulant solution, leakage may be detected by pressing 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 blo
14、od and blood components. 5) Biological compatibility inspection of single packing: take out 5 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
15、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 refers to ISO3826:1993 plastic collapsible containers for human blood
16、and blood components. 7) Label system inspection of single packing Take out 5 pieces conveniently label stuck with lot 2003021811, 2003021812, 2003021813, inspect one by one according to EN980 package and symbol of medical polymer products including: (1) General demands a) The symbol indicated on package should be instruct to shipments, storage, tearing open and usage b) The symbol indicated on package should be clear,
