市售電子血壓計準確度試驗之品質調查

Survey on the Quality of Non-Invasive Sphygmomanometers in Taiwan

為了解市售電子血壓計準確度品質之現況，本計畫委請各縣市政府衛生局針對轄區內各藥局、醫療器材行或大賣場等地進行抽驗，共計抽得血壓計18件。其中包含國產品6件及輸入品12件。測試方法參考中華民國國家標準CNS 15041「非侵入式血壓計-第1部：一般規定」第8.1節之方法進行壓脈帶壓力顯示之誤差限制值項目進行準確度試驗，檢驗結果顯示所有抽樣之電子血壓計皆符合規範，相關檢驗結果將提供行政管理單位參考，期能持續了解並監控市售電子血壓計產品品質。

The post-market surveillance in the medical device, non-invasive sphygmomanometer was supported by local health authorities who collected 18 devices in total from pharmacies, medical device stores and hypermarkets in retail market of Taiwan from January to June in 2015. The collected samples included 6 domestic and 12 imported products. The limits of the error of the cuff pressure indications of devices were tested following Chinese National Standards (CNS) 15041-1. The detected pressure differences between non-invasive sphygmomanometers (sample devices) and manometer (reference device) must be less than 3 mmHg. The results showed all the non-invasive sphygmomanometers surveyed in this study met the requirement, and the reports will be sent to the local health authorities for reference.