(2014年08月04日,台北訊) —— 全球安全科學領導者 UL (Underwriters Laboratories) 宣佈,美國食品藥物管理局 (FDA) 認可 UL 的兩項電池安全標準 UL 2054 及 UL 1642,為含有鋰電池或鎳電池醫療器材的共識標準 (Consensus Standards) ,其中 UL 2054 為家用與商用電池標準,UL 1642 為鋰電池標準。這兩項由 FDA 所認可的共識標準,用於醫療器材在獲准進入市場前,對其進行評估。FDA 轄下的醫療器材管理中心 (Center for Devices and Radiological Health, CDRH) 相信,醫療設備符合該共識標準,將有助於確保其在眾多應用方面的安全性和/或有效性。在採用電池的醫療器材中,製造商可以 UL 2054 和 UL 1642 認證,來證明器材的安全性和有效性。UL 電子科技產業部電池經理 Ibrahim Jilani 表示,「共識標準也是簡化上市前評估流程的一種方式。採用這種認可的標準不僅將有助於醫療器材製造商,減少進入美國和國際市場的障礙,還有助於達到 FDA 上市前的評估要求。」儘管該認證在美國屬自願性質,但此次 FDA 採用共識標準的宣布,預期未來很可能成為監管上的極大驅動力,醫療器材製造商亦將努力取得 UL 2054 的鎳電池認證、UL 1642 的鋰電池認證和/或 UL 2054 的電池組認證。Jilani 進一步表示:「在電池標準制定、電池安全性與性能測試、培養產業內創新和增強對電池品質的信心方面,UL 擁有 30 多年的經驗。我們認為醫療器材製造商和用戶均將從在美國和全球市場進行 UL 的電池安全性標準評估的產品中受益。」

諮詢有關 UL 的電池測試與認證的詳情,敬請閱覽:https://www.ul.com/batt 和/或 https://www.ul.com/largebatt (針對大型電池)。

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