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Quality Control Test.doc

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Quality Control Test

Foshan Nanhai Baihe Medical Technology Co. Ltd. Quality Control Test No: QB2210 PROCEDURE FOR HEMODIALYSIS CATHETER Date: 2010-3-31 Originator Authorizer Revision:2 Pan Muqiu Ge Baoyou Page: 1 of 5 1. PURPOSE This procedure shows a complete quality control test on finished Hemodialysis Catheter. 2. SCOPE 2.1 This procedure shall apply for all type and size of Hemodialysis Catheters (single lumen, double lumen, and triple lumen). 2.2 The QA final / pre-shipment inspection shall be carried out based on respective Packing work Order (PWO). 3. REFERENCES 3.1 ISO 13485:2003 Management System Certificate 3.2 CE 0434 Certificate of Assessment 3.3 FH-1714 Product Specification for single lumen Hemodialysis Catheter 3.4 FH-1715 Product Specification for single lumen Hemodialysis Catheter 3.5 FH-1814 Product Specification for single lumen Hemodialysis Catheter 3.6 FH-1815 Product Specification for single lumen Hemodialysis Catheter 3.7 FH-2114 Product Specification for double lumen Hemodialysis Catheter 3.8 FH-2114W Product Specification for double lumen Hemodialysis Catheter 3.9 FH-2115 Product Specification for double lumen Hemodialysis Catheter 3.10 FH-2116 Product Specification for double lumen Hemodialysis Catheter 3.11 FH-2116W Product Specification for double lumen Hemodialysis Catheter 3.12 FH-2214 Product Specification for double lumen Hemodialysis Catheter 3.13 FH-2215 Product Specification for double lumen Hemodialysis Catheter 3.14 FH-2216 Product Specification for double lumen Hemodialysis Catheter 3.15 FH-3215 Product Specification for triple lumen Hemodialysis Catheter 3.16 FH-3215W Product Specification for triple lumen Hemodialysis Catheter 3.17 BH 6001 Sampling plan Buy-Off procedure for Hemodialysis Catheters at fini