2010-01-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/663728摘要：奈米科技的新興帶動了奈米醫療器材的發展，然而醫療器材在上市前除考量其功能性外，亦有安全性之考量。目前國際趨勢普遍認為，為了評估奈米材料的風險，現有的安全性評估方法應加以改良，這也代表了原先醫療器材安全性評估標準規範ISO 10993並無法完全符合奈米醫療器材安全性評估的需求。鑒於國際奈米醫療器材目前尚需要良好的安全性評估方法與標準品，因此本計畫主要目的在結合奈米材料、醫療器材生物相容性測試與動物毒理研究專長教授組成團隊，共同建立奈米醫療器材應用安全性評估模式與相關測試之標準對照材料，以實證結果提供相關主管機關審查管理及產業測試的參考，使奈米醫療器材的管理能與國際同步化，健全奈米科技環境，加速國內奈米醫療器材產業的發展。<br> Abstract: Due to the emergence of innovative nanotechnology, the medical devices incorporating nanomaterials have raised a concern about environmental contamination, material safety and product verification of effectiveness. New safety evaluation protocols should be established to prevent the possible risks from the the incorporation of nanomaterials during the course of new development of medical devices. Since all medical devices need to have their effectiveness and safety verified before commercialization, the establishment of safety evaluation is crucial for the research and development of medical devices incorporating nanotechnology. This proposal is aimed to establish the safety evaluation methods, particulary involving the uses of inorganic nanoparticles for medical devices. In this project, the nanosized particles will be standardized by synthesizing their reference materials, as well as the in vitro and in vivo testing methods to evaluate their biocompatibility and safety of the medical devices incorporating with these nanopaticle materiasls with controlled sizes. The systematic studies and comparative results can provide scientific information and strategic plan to DOH for managing and reviewing nanotechnology-incorporated medical devices and offer a service to the medical device industry and investors.奈米醫療器材奈米材料安全性評估標準測試方法標準品(對照材料)標準化medical devices incorporating nanotechnologynanomaterialssafety evaluationstandard testing methods (STM)standard reference materialsstandardization