頁籤選單縮合
題 名 | 市售電子體溫計準確度試驗之背景值調查=A Survey of Accuracy Test for Electronic Thermometers in Taiwan |
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作 者 | 方毓廷; 黃守潔; 洪志平; 陳玉盆; 闕麗卿; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 3 2012.11[民101.11] |
頁 次 | 頁242-245 |
分類號 | 410.025、410.025 |
關鍵詞 | 電子體溫計; 準確度試驗; Electronic thermometer; Accuracy tests; Quality surveillance; |
語 文 | 中文(Chinese) |
中文摘要 | 為配合行政院衛生署98.06.15衛署藥字第0980014889號公告「臨床電子體溫計」臨床前測試基準,本局於100年5至11月間,派員至藥局及醫療器材行,抽購不同製造廠之電子體溫計10件,包括國產品4件、輸入品1件及大陸輸入品5件;每件2台,共計20台。依據中華民國國家標準CNS 15043「間歇性測定患者體溫之電子體溫計」4.5.1節「操作環境測試」之規定進行溫度測量準確度試驗品質調查。檢驗結果:1件超出CNS最大誤差值標準之要求,本計畫為背景值調查,其結果將做為行政管理參考。 |
英文摘要 | Food and Drug Administration in Taiwan had conducted the accuracy tests in accordance with the section 4.5.1 "Operating Environment Tests" cited in "CNS 15043 Standard specification for electronic thermometer for intermittent determination of patient temperatures." The surveillance was carried out from May to November, 2011. Ten samples which were from 10 different manufacturers were collected from medical equipments shops and drugstores. There were 4 domestic products and 6 imported products, 1 from Germany and 5 from China, among those samples. The results revealed that 1 sample was out of the acceptance criteria of the CNS standards. This surveillance was a preliminary study and the results shall be implemented in the medical devices regulating system. |
本系統中英文摘要資訊取自各篇刊載內容。