- 期刊
市售彩色隱形眼鏡之色素溶出物試驗品質監測
Survey of Marketed Daily Wear Contact Lenses in Taiwan
摘要
隱形眼鏡是直接配戴在角膜及眼睛鄰近邊緣區或鞏膜區，用來矯正視力或作為治療用繃帶的器材。依據本署於99年9月30日署授食字第0991612765號公告「軟式隱形眼鏡醫療器材臨床前測試基準」，本計畫進行彩色隱形眼鏡色素溶出物試驗之實測評估。本署於102年1至10月間，派員及委由各縣市衛生局赴轄區內眼鏡行、隱形眼鏡公司、經銷商、代理商、藥局、製造廠、大賣場等地進行市售產品之抽驗，抽得日拋彩色隱形眼鏡產品共30件，其中國產品19件，輸入品11件。本計畫參考各產品原查驗登記資料及本署101年所建立之試驗方法進行彩色隱形眼鏡色素溶出物檢驗，結果30件檢體均未檢出色素溶出物。
並列摘要
Contact lenses were worn directly on the cornea and the sclera for vision correction. In order to investigate the conformity of marketed daily wear contact lenses to the ＂Guidance for Pre-clinical Testing of Soft (Hydrophilic) Contact Lenses＂ announced by the Department of Health, thirty samples were randomly collected from optician's stores, distributors, agents, drug stores or pharmacies by local health authorities in Taiwan area from January to October, 2013. These samples included 19 domestic products and 11 imported products. They were examined with each product's original registration data and the color additive extraction testing method we established for soft contact lenses. The results revealed that color additives were not detected in all samples.
被引用紀錄
延伸閱讀
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