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標題: 含奈米材料/科技之醫療器材之生物安全性法規策略探討
Regulation Strategy for the Biological Safety of Medical Devices Incorporating Nanomaterials/ Nanotechnology
作者: 徐善慧
關鍵字: 基礎研究;nanotechnology;醫學工程, 法律學;奈米科技;安全性;法規;safety;regulation strategy
The rising of nanotechnology brings great commercial interests. Nowadays, every country is engaged in inventing new products of nanotechnology. Many products incorporating nanomaterials/nanotechnology have proven to be more efficient and profitable, in the area of biomaterials, electronics, computer technology, medical and health, environment, energy, biotechnology and national security.Because the application of nanomaterials in biomaterials and medical devices do not have clear and definitely safety strategies and regulations, the application of nanomarterials may have uncertainty and risks, quoted from the report of "Nanoscience and Nanotechnologies: Opportunities and Uncertainties" by the Royal Society and the Royal Academy of Engineering. There was the establishment of Center for Responsible Nanotechnology. FDA is also investigating the risk analysis, premarket approval and postmarketing surveillance of nanoproducts. All these show the importance of regulations for nanotechnology. There are two purposes in this study. The first purpose is to collect the foreign regulation strategies for nanoscience and nanotechnology. These include the regulations of nanomaterials that contact or enter the human bodies or the manufacture environments. The other purpose is to discuss and establish the biological safety of medical devices incorporating nanomaterials/nanotechnology by collecting the risk factors, and expert opinions from expert meeting to get the adaptive regulation, the flowchart of risk evaluation, and the tests of medical devices incorporating nanomaterials/ nanotechnology. Finally, we will hold a discussion about the regulation and safety of medical devices incorporating nanomaterials/ nanotechnology and provide a report containing: (1) the references of regulations for administrators; (2) the suggestions for the investors and industry; and (3) the windows for educating and protecting consumers.

奈米科技的興起帶來巨大的商機,各國莫不想要在最短的時間內,創造出產值最大的產品,以在各產業中取得先機,現在不但有許多奈米產品上市,也證明了其更小、更有效、有更高的收益,在材料與製作、奈米電子及電腦技術、醫藥與健康、航空及太空冒險、環境及能源、生物科技、國家安全各方面都有很好的發展,但因為奈米材料應用在生醫材料為一種新興的材料,存在著許多的未知風險,有關的奈米生醫材料安全性策略及法規都未明確,且英國皇家工程學院與學會(The Loyal Society and The Royal Academy of Engineering)對英政府的報告,「奈米科學和奈米科技:機會和不確定性(Nanoscience and nanotechnologies: opportunities and uncertainties)」[1]、奈米科技責任中心的建立;美國食品與藥物管理局也為奈米產品建立了風險分析、上市前核定、上市前可接受性及上市後監督等措施,都表明各國對奈米科技安全性的重視,所以本研究主要目的可分為兩個重點,第一個重點為法規策略方面,以蒐集國外對奈米科學及奈米科技的法規或策略對應措施,針對接觸或進入人體的奈米級生醫材料、生產環境等方面,進行深入的探討,第二個重點在於對含奈米材料/科技之醫療器材之生物安全性做探討,蒐集奈米風險監控的風險因子,以專家問卷的方式,蒐集專家意見,如主管機關、專家學者、產業界,以得到最適合台灣含奈米材料/科技之醫療器材之法規策略、建立風險評估流程、奈米安全性風險標準品(如可降解的奈米級材料)及含奈米材料/科技醫療器材之檢測方式,並舉辦奈米法規說明會及奈米材料安全說明會,藉以提供1.主管機關管理奈米材料的參考對策、2.廠商投資經營建議及3.保護及教育消費者的管道。
其他識別: DOH95-TD-D-113-013
Appears in Collections:化學工程學系所

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