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

10.6946/ASRNL.200309.0011

簡哲新(Che-Hsin Chien)；吳亭瑤(Ting-Yao Wu)；杜培文(Pei-Weng Tu)；黃明權(Ming-Chuan Huang)

經皮神經電刺激器TENS ； 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

藥物食品檢驗局調查研究年報

21號（2003 / 09 / 01）

11 - 16

繁體中文

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。

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).