验证方案(包装、包括报告)(英文)VIP免费

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 appraise4. 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 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 in order to approve 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 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 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 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 ...