驗(yàn)證方案(包裝、包括報(bào)告)(英文)

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 appr

2、aise4. 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 fro

3、m 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 general requirements and inspect methods, with regard to our inner packing, we carry out the inspections in order to app

4、rove of 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

5、 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:3) Prevent bacteri

6、um inspection 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 hol

7、ding 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, the appraise of steriliza

8、tion 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 inspection of single packin

9、g: 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 inspect methods.3) Prevent b

10、acterium 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 parts: the general requireme

11、nts 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 container shall not develop leaks

12、 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 plastic container is filled

13、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 blood and blood components.5) Bi

14、ological 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 the first part: appraise and te

15、st.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 and blood components.7) Label sy

16、stem inspection of single packingTake 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 demandsa) The symbol indicated on package should be instruct to shipment

17、s, storage, tearing open and usageb) The symbol indicated on package should be clear, perspicuity, fastness, It is forbidden to brush off or slur in the process of sterilization, shipments and storage.c) The symbol of parliamentary packing should be typed on the outer surface but not except for cons

18、idering that removing can influence on the quality in the package. (2) The general information on the single packinga) Products name. style or specificationb) The manufacture name, address and brandsc) Production lot or date:d) “non-sterilize” letters and/the non-sterilize symbol of drawing “destroy

19、ed after using” letters: e) If the single packing is broken, do not use the products. “Package broken not to use” must be indicated.f) Single use instruction/symbol design:g) Expiry date:The second part-over-package inspection1. Inspect purpose:.Based on the requirements from European CommunityMedic

20、al 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 packing material, we carry out the inspections as following:1) Non-ventilate inspec

21、tion of single packing:2) Prevent bacterium inspection of single packing:3) Agglutinate of seal inspection of single packing:2. Contents of inspection:1) Non-ventilate inspection of over-package: Take off the outer packing, and take out 5 pieces conveniently with lot number 20030111, 20030120, 20030

22、127 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, the person who concerning will carry out Non-ventilate inspection of single packing.2) Prevent bacterium ins

23、pection of over-package: Take off the outer packing, and take out 5 pieces conveniently with lot number 20030111, 20030120, 20030127 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

24、and inspect methods, the person who concerning will carry out prevent bacterium inspection of single packing.4) Agglutinate of seal inspection of over-package: according to the requirements, put the products into single packing, setting the parameter on the seal machine, each groups can seal 5 piece

25、s with lot number 20030111, 20030120, 20030127 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, the person who concerning will carry out agglutinate of seal insp

26、ection of single packing:Groups ParameterSeal temperatureConvey speed1200High2210High3220High . 3.The final approval:The above-mentioned experiments were checked and approved by inspection groups with appraise and analysis, the eligibility documents will hand over to departments for putting into app

27、lication.3. Inspection organization4.1 Inspection principal: Cheng Yunliang Workshop member: Zhang Yanhong Dong Lujing Dou XiaojieManufacture departments member: Tian Xuefei Zhao Zhendong Li Xiouying Zhang Cuiyan4.2 Duty and divide the workWorkshop: charge the records of process of production; stric

28、tly control the process of productionManufacture departments: harmonize and do correspondent documents in the process of inspection.5.Works schedule: In vision, the work will be finished in Mar, 2003.XXX Group Corp.Medical Polymer products Co., LTD Packing inspect reportsName: the arts and crafts in

29、spection of packingDocuments serial No: VP-002draftsmanexamine and approveratifierSignDateCollect sign dept.Collection sign Date Catalogue1. Summarize2. Packing inspection project3. Contents of inspection in single package4. Contents of inspection in over-package5. Conclusion of inspection6. Attachm

30、ent documents1. SummarizeThe disposable Plastic Blood bags made by us are packed inner package with high temperature co-ex plastic bags which are made from PP-PET material. Mid-packing usually are adopted aluminum plastic. Based on the requirements from European CommunityMedical Device instruction (

31、MDD93/42/EEC) and BP/CX-21-07, 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 of measuring up the requir

32、ements of medical device instruction (MDD93/42/EEC).2. Inspect projectThe inspect project is compiled by Technology Dept with collect signed by several of departments, and authorized by administer.3. Inspect carrying into executionAccording to packing inspect project, we composed inspection groups t

33、o inspect items as following:3.1Preliminary contaminated Inspection of single packing:Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: GB15980-1995 the disposable medical products hygiene standards Inspect results: measure up requirements Inspe

34、ct reports: the reports about preliminary contaminated inspection of single packing3.2 Non-ventilate inspection of single packing:Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: EN868-1-Medical Device sterilized packing material and system-the

35、 first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about non-ventilate inspection of single packing.3.3 Prevent bacterium inspection of single packing:Description and type: 250 ml triple bags, lot number 20030218, 20030219

36、, and 20030220:Inspect reference: EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about prevent bacterium inspection of single packing:3.4 Resistance to l

37、eakage inspection of single packing:Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: EN868-1:1993 Plastic collapsible containers for human blood and blood components Inspect results: measure up requirements Inspect reports: the reports about Re

38、sistance to leakage inspection of single packing:3.5 Biological compatibility inspection of single packing:Description and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: PRENAISO10993-1:1997 biological appraise of medical deviceInspect results: measure up re

39、quirementsInspect reports: the reports about biological compatibility inspection of single packing:3.6 Toxicity inspection of single packingDescription and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: EN868-1:1993 Plastic collapsible containers for human b

40、lood and blood components Inspect results: measure up requirements Inspect reports: the reports about toxicity inspection of single packing:3.7 Label system inspection of single packingDescription and type: 250 ml triple bags, lot number 20030218, 20030219, and 20030220:Inspect reference: EN868-1:19

41、93 Plastic collapsible containers for human blood and blood components and package and symbol of medical device products. Inspect results: measure up requirements Inspect reports: the reports about Label system inspection of single packing:4. The inspection of over-package4.1 Non-ventilate inspectio

42、n of over-package:Lot number: 20030218, 20030219, 20030220:Inspect reference: EN868-1-Medical Device sterilized packing material and system-the first parts: the general requirements and inspect methods Inspect results: measure up requirements Inspect reports: the reports about non-ventilate inspection of over-package4.2 Prevent bacterium inspection of over-package inspection of over-package:Lot number: 20030218, 20030219, 20030220:Inspect reference: EN868-1