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藥物食品檢驗局調查研究年報
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中文摘要
為了解市售紅外線耳溫槍之準確度，本局於民國96年1月至2月期間，派員至藥局及醫療器材行抽購不同製造廠所生產之紅外線耳溫槍檢體11件，委託合約實驗室依據歐盟標準EN 12470-5：2003之方法及規格進行準確度檢測，檢測結果共8件（72.7％）不符合歐盟標準之要求。
紅外線耳溫槍原列屬無須辦理查驗登記之醫療器材，經衛生署89年6月21日重新分類分級為第二等級醫療器材，於94年6月21日起須取得醫療器材許可證後方可上市。依據醫療器材查驗登記審查準則之規定，廠商可檢附完整之臨床前測試資料或以減免上述資料之簡化方式申請。本局執行本計畫，除為了解紅外線耳溫槍準確度以保障民眾健康外，亦希望能建立背景資料，確認該標準方法之可行性。因應實際需要，建議衛生署可參考國際、區域、各國相關標準及本次檢測結果，訂定紅外線耳溫槍檢測規範，俾使政府之管理及製造廠之生產能有所依循。
英文摘要
In order to ensure the quality of infrared ear thermometers distributed in Taiwan, 11 samples were purchased from drugstores and medical suppliers during the period from January to February 2007. According to the test methods and specifications listed in EN 12470-5:2003 for infrared ear thermometers (with maximum device), the accuracy (± 0.2℃) was tested. The results showed that 8 samples (72.7%) failed to meet the
requirements of EN 12470-5:2003.
Pre-approval registration was not required for infrared ear thermometer prior to its re-classification as Class II medical devices in June 20, 2000. The survey was thus conducted to ascertain the accuracy of infrared
ear thermometers in Taiwan market in order to protect the public health. Furthermore, the testing results can be implemented as the background information for establishing regulations of medical devices in the future.