市售電子血壓計準確度試驗之品質調查

Quality Survey of Pressure Accuracy for Electronic Sphygmomanometers in Taiwan

林隆泰(Lung-Tai Lin) ； 黃聖傑(Sheng-Chieh Huang) ； 杜培文(Pei-Weng Tu) ； 鄒玫君(Meir-Chyun Tzou)

《藥物食品檢驗局調查研究年報》 27期 (2009/12) Pp. 13-16

https://doi.org/10.6946/ASRNL.200912.0013

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。

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

並列摘要

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.

並列關鍵字

electronic sphygmomanometers ； accuracy ； limits of the error of the cuff pressure indication