- 學位論文
中空纖維透析器測試系統設計與試驗
Experiments and system design on hollow fiber Hemodialyzers
摘要
血液透析器的機械特徵試驗應符合法規或國際標準的要求，以確保臨 床上使用之安全。本研究採用Fresenius HdF 100S( High Flux)和Fresenius F7 HPS ( Low Flux)兩型各取3 支血液透析器；並設計測試系統進行機械特徵 試驗，取得之完整數據紀錄實驗過程與步驟，未來將可做為國內執行研發 中空纖維透析器之機械特徵試驗之參考。本研究遵照國際標準ISO 8637： 2010，試驗的項目包括血液透析器結構完整性、血液腔室完整性、血液腔 體積與血液腔及透析液腔之壓力落差。試驗結果所有透析器皆通過結構完 整性及血液腔完整性之試驗，另外在做氣泡點壓力試驗時，得到透析器最 高可承受的壓力數據；血液腔體積HdF 100S 和F7 HPS 的數據為體積法 124±1mL 與88±1mL，重量法125±1mL 與89±1mL 和公式計算出109.3mL 與82mL；壓力落差之數據為血液腔壓力落差為19±2mmHg (HdF 100S)、 23±2 mmHg (F7 HPS)，公式計算出為13.7mmHg(HdF 100S )、15.6mmHg(F7 HPS)；透析液腔壓力落差為8±2mmHg (HdF 100S)與10±2 mmHg (F7 HPS)， 公式計算出為12.9mmHg (HdF 100S)與9.7mmHg (F7 HPS)，結果顯示兩型 透析器皆通過測試，試驗結果之數據未來將可做為國內執行研發中空纖維 透析器之機械特徵試驗之參考。
並列摘要
The test of the mechanical characteristics of dialyzers should conform to legal regulations or international standards in order to ensure the safety of usage clinically. This study adopted two types of Fresenius HdF 100S (High Flux) and Fresenius F7 HPS (Low Flux) and tested with 3 dialyzers respectively. A test system was designed to perform the test of mechanical characteristics. Completed data of the test was collected and the test processes and procedures were recorded. The results of the study can be used as references for the experiments of the mechanical characteristics when develop domestic hollow-fiber dialyzers in future. This study abided by the international standards of ISO 8637：2010, the test items include the structural integrity of dialyzer, the integrity of blood compartment, the volume of the blood compartment, the pressure drops of blood and dialysate compartments.The results of the study showed that all dialyzers passed the test of structural integrity and the integrity of blood compartment. In the bubble-point test, the data of the maximum pressure which the dialyzers could withstand was collected too; The volumes of blood compartments of HdF 100S and F7 HPS were 124±1mL and 88±1mL respectively by volume method; 125±1mL and 89±1mL respectively by gravimetric method and 109.3mL and 82mL respectively by formula calculation. The pressure drops in the blood compartments of these two types of dialyzers were 19±2mmHg (HdF 100S)and 23±2 mmHg (F7 HPS), while that were 13.7mmHg (HdF 100S ) and 15.6mmHg(F7 HPS) by formula calculation. The pressure drops in dialysate compartments were 8±2mmHg (HdF 100S) and 10±2 mmHg (F7 HPS), while that were 12.9 mmHg (HdF 100S) and 9.7 mmHg (F7 HPS) by formula calculation. The data results of the test can be used as references for the experiments of mechanical characteristics in the domestic d evelopment of hollow-fiber dialyzers in future.