頁籤選單縮合
題 名 | 市售疼痛舒緩用經皮神經電刺激器之輸出電性安全測試、功能控制鍵測試、短路與開路測試及電池極性反向測試品質調查=An Investigation on the Output Characteristics tests、Functional Controls tests、Open/Short Circuit Performance tests、Incorrect Battery Installation tests of Transcutaneous Electrical Nerve Stimulators Distributed in Taiwan Market |
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作 者 | 簡哲新; 吳亭瑤; 杜培文; 黃明權; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 21 2003.08[民92.08] |
頁 次 | 頁11-16 |
分類號 | 410.025 |
關鍵詞 | 經皮神經電刺激器; 輸出電性安全測試; 功能控制鍵測試; 短路與開路測試; 電池極性反向測試; Transcutaneous electrical nerve stimulators; TENS; Output characteristics tests; Functional controls tests; Open/short circuit performance tests; Incorrect battery installation tests; |
語 文 | 中文(Chinese) |
中文摘要 | 本計畫自民國九十一年五月至六月,由本局同仁自行至台北縣市之醫療器材行、保健器材行、百貨公司及藥局抽購「經皮神經電刺激器」檢體共計20 件。經以美國AAMI NS4「經皮神經電刺激器」標準之方法、規格進行檢測,共包括輸出電性安全測試、功能控制鍵測試、短路與開路測試及電池極性反向測試等四個項目。測試結果:共3 件(15.0%)不符合美國AAMI NS4 之輸出電性安全測試規定;此外,本次抽購的20 件檢體中,有5 件未依規定辦理查驗登記。 |
英文摘要 | In order to ascertain the quality of Transcutaneous Electrical Nerve Stimulators, 20 samples were purchased from medical supplyers, department stores and pharmacies from Taipei county/city during the period from May to June 2002. Four tests which included output characteristics tests, functional controls tests,open/short circuit performance tests and incorrect battery installation tests were conducted according to the methods listed in ANSI/AAMI NS4 for Transcutaneous Electrical Nerve Stimulators. The results showed that three samples (15.0%) failed to meet the requirements in output characteristics tests. In addition, among these 20 samples, five samples did not obtain pre-market approval from Department of Health (DOH). |
本系統中英文摘要資訊取自各篇刊載內容。