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血液透析用刺針套組之研發與品管

The Development and Quality control of Arterial Venous Fistula Needle Set

摘要


血液透析用刺針套組為經常性的血液透析治療之必需用品。本報告包括血液透析用刺針套組之研發與品管工作。以常用的醫療且安全之聚合物,先進行材料與血液相容性的測試評估。最後選定使用polyvinyl chloride, polystyrene, polyethylene等聚合物進行生產。生產血液透析用刺針套組所需的材料與方法及品管之儀器與方法、規格均於本報告中敘述。

並列摘要


Fistula needle set is used for haemodialysis. This report covers the development work of A.V. Fistula cannula with intention to manufacture it according to Good Manufacturing Practice. Commonly considered biological safe polymers were evaluated in terms of their compatibility with blood. Medical grade soft and rigid polyvinyl chloride, polystyrene, and polyethylene were selected to produce various parts for the cannula. Manufacturing machinery and method, test instrument, test method, and specifications were in details in this report.

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