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藥物食品檢驗局調查研究年報
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| 篇名 | 市售電子血壓計準確度試驗之品質調查 |
|---|---|
| 卷期 | 27 |
| 並列篇名 | Quality Survey of Pressure Accuracy for Electronic Sphygmomanometers in Taiwan |
| 作者 | 林隆泰 、 黃聖傑 、 鄒玫君 、 杜培文 |
| 頁次 | 013-016 |
| 關鍵字 | 電子血壓計 、 準確度 、 壓脈帶壓力顯示之誤差限制值試驗 、 electronic sphygmomanometers 、 accuracy 、 limits of the error of the cuff pressure indication 、 TSCI |
| 出刊日期 | 200910 |
中文摘要
本局於民國97年9、10月間，派員於北部地區(台北市、桃園縣)藥局及醫療器材行抽購
市售電子血壓計檢體共計10件，包括2件國產品，8件輸入品(其中2件為日本製造、1件為德
國製造、1件為印尼製造、4件為大陸製造)。並依據中華民國國家標準CNS 15041-1 (2007)
「非侵入式血壓計－第1部：一般規定」(1)中壓脈帶壓力顯示之誤差限制值試驗方法進行檢
驗判定。檢驗結果：壓力準確度試驗有1件不符合標準規範。本計畫為初步背景值調查，其
結果將做為行政管理參考。
英文摘要
In order to ascertain the accuracy of electronic sphygmomanometers in Taiwan, a survey was carried out from September to October, 2008. 10 samples were collected from drugstores and medical equipment shops in
northern area of Taiwan (Taipei City and Tao-Yuan County). Among those samples, 2 were domestic products and the others were imported products (2 from Japan, 1 from Germany, 1 from Indonesia and 4 from Mainland
China).
The tests were conducted in accordance with the section 7.1.1 “Limits of the error of the cuff pressure indication” cited in CNS 15041-1 Specification for non-invasive sphygmomanometers – Part 1: General
requirements.” One sample was found not comply with the standard. This survey was a preliminary study and the results can be implemented in the medical devices regulating system.