- 學位論文
血液透析機標準比較與性能測試研究
Standard comparison and performance Testing for Hemodialysis Delivery System
摘要
摘 要 我國在醫療器材管理上，對於器材的技術要求大多採認國際標準或先進國家標準並針對透析機安全性進行測試，本研究針對血液透析治療用的透析機為進行對象。標準比較與性能測試研究包括比較ANSI/AAMI RD5與IEC60601-1-1及IEC60601-2-16標準。經比較兩套專用標準後發現，AAMI RD5透析機監測、控制、警報防護等均以數據規範，而IEC60601-2-16對透析機電性安全要求則有著明確的規定，對照FDA上市指引中標準之要求，透析機標示與操作須符合AAMI之要求，電性安全須依據IEC60601-1要求作測試，亦須通過IEC60601-1-2電磁相容性測試認證。藉由透過以ANSI/AAMI RD5標準執行對透析機中透析液與血液迴路其監測、控制與警報等功能進行性能測試及以IEC60601-1合併IEC60601-2-16執行電性安全中漏電流防護測試，來確認血液透析機使用時之安全性。經上述測試得到數據與結果均合乎標準中內容之要求。藉由執行上述測試標準比較與測試，可供國內醫療單位對透析機標準的了解與如何執行測試，為確保透析機安全功效。另外，也提供國內廠商開發透析機的重要參考。
並列摘要
Abstract The management for medical devices in Taiwan usually refers to the international standards or standards of developed countries. This study aims to compare several standards and to investigate the performance testing for hemodialysis machine. In this study, standards including ANSI/AAMI RD5, IEC60601-1 and special standards of IEC60601-2-16 are investigated. Among these standards, the ANSI/AAMI RD5 is to test the monitor, control and alarms of the blood circuit for hemodialysis machine. To follow the FDA requirement in ‘’Guidance of the Content of Premarket Notifications for Hemodialysis Delivery Systems’’, symbols and running on hemodialysis machine are to follow by the AAMI/RD5, and electrical safety for the hemodialysis machine has to be passed the IEC60601-2-16 and IEC60601-1-2 testing. The standards of AAMI/RD5 and leakage current testing in standards of IEC60601-2-16 test for the monitor, control and alarms of the blood circuit for hemodialysis machine. The other standard, IEC60601-1 coupling with IEC60601-2-16 is to test the leakage current testing in safety of hemodialysis. As the results, we observed that all the testing were satisfied with above standards. According to above study, we can not only understand and execute these standards, but also offer the important parameters for the development of hemodialysis machine in Taiwan.