Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/58978
DC FieldValueLanguage
dc.contributor.author徐善慧zh_TW
dc.contributor.author蘇建銘zh_TW
dc.contributor.other行政院衛生署zh_TW
dc.contributor.other國立中興大學化學工程學系zh_TW
dc.date2004zh_TW
dc.date.accessioned2014-06-06T13:19:41Z-
dc.date.available2014-06-06T13:19:41Z-
dc.identifierDOH92-TD-1108zh_TW
dc.identifier.urihttp://hdl.handle.net/11455/58978-
dc.description.abstract本計畫擬研究醫療器材(medical devices)與生醫材料(biomaterials)的管理與標準中之安全性評估(safety evaluation),即材料與人體在生物與化學上的複雜交互作用之評估與標準制度之建立。本計畫不包含醫療器材的醫療有效性(effectiveness)評估。在這一兩年公告的醫療器材及生醫材料的分級管理(classification),雖已將其分為三類,並要求Class II器材進行生物相容性評估,但並未建議項目。而經濟部標準檢驗局自今年才開始以ISO 10993為藍本,翻譯擬定醫療器材生物相容性評估相關國家標準草案,其中對於項目也是以選擇清單等觀念予以建議。然而標準(standardization)非等同於管制(regulation);對於安全性評估所用的方法,若參酌調和國際醫療器材生物測試已有之標準(ASTM, ADA等),或藥典(USP)等,主管單位又應如何看待。此外,標準非等同於方法(methods),在標準中常只見名目,卻缺乏細節(如ISO 10993-4 血液相容性標準等)。基於以上種種原因可看出,標準草案之擬定,並不等同於標準制度的建立,甚至更需要標準制度的建立,才能達到提昇醫療器材的水準。故短期之內,應先完成醫療拋棄材(medical disposables)之測試項目與內容標準,並完成所有各級產品(class I, II, III, TEMP)上市申請應執行之測試項目清單與標準。同時配合有系統之訓練課程,推廣產業界對安全性評估之認知。經由以上衛生暑之科技計畫內容執行,期望醫療器材與生醫材料安全性評估規範得以確立,促進國內生醫材料與醫療器材產業迅速升級,並走向國際化。zh_TW
dc.description.abstractThis project is to study the standardization and regulation for the safety evaluation of medical devices and biomaterials. For each different class of medical devices and biomaterials (class I, II, III as well as tissue engineering medical products), the required safety test matrix and methods will be established. Such information will be provided for the regulators as well as the medical device industry in Taiwan.en_US
dc.language.isozh_TWzh_TW
dc.relation.urihttp://grbsearch.stpi.narl.org.tw/GRB/result.jsp?id=797981&plan_no=DOH92-TD-1108&plan_year=92&projkey=PG9201-0668&target=plan&highStr=*&check=0&pnchDesc=%E9%86%AB%E7%99%82%E5%99%A8%E6%9D%90%E8%88%87%E7%94%9F%E9%86%AB%E6%9D%90%E6%96%99%E4%B9%8B%E5%AE%89%E5%85%A8%E6%80%A7%E8%A9%95%E4%BC%B0%EF%BC%9A%E7%94%9F%E7%89%A9%E6%B8%AC%E8%A9%A6%E4%B9%8B%E6%A8%99%E6%BA%96%E5%88%B6%E5%BA%A6%E5%BB%BA%E7%AB%8Ben_US
dc.subject應用研究zh_TW
dc.subjectmedical devicesen_US
dc.subject醫學工程zh_TW
dc.subject醫療器材zh_TW
dc.subject生醫材料zh_TW
dc.subject安全性評估zh_TW
dc.subjectbiomaterialsen_US
dc.subjectsafety evaluationen_US
dc.title醫療器材與生醫材料之安全性評估:生物測試之標準制度建立zh_TW
dc.titleSafety Evaluation of Medical Devices and Biomaterials: Biological Evaluation- Standardization and Regulationen_US
dc.typeResearch Reportszh_TW
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