市售外科手術口罩之品質監測

Survey on the Quality of Marketed Surgical Masks in Taiwan

本計畫以風險評估原則，選定市售外科手術口罩進行品質監測，由北、高兩市及各縣市衛生局，於民國97年1月至9月間，赴轄區內製造廠及代理商處抽驗市售檢體，抽得外科手術口罩12件，包括國產品及輸入品各6件，委託合約實驗室依據中華民國國家標準CNS14774〔醫用面罩〕中外科手術口罩之性能規格要求及其指定之標準方法，進行合成血液穿透性、細菌過濾效率、次微米粒子防護效率、壓差及可燃性等項目檢驗，結果1件國產品合格。不合格產品已函復抽樣衛生局依藥事法處理，以確保市售產品品質。

Surgical masks in Taiwan market were chosen for postmarket testing based on the results of risk assessment in 2008. A total of 12 samples, six domestic and six imported, were collected by the local health authorities from manufacturers and importers in different counties and cities of Taiwan in a period from January to September 2008. According to the test methods and specifications listed in CNS 14774 (T5017): 2003 for surgical masks, the performances of fluid resistance, bacterial filtration efficiency, particulate filtration efficiency, differential pressure and flammability class were tested by contracted laboratory. The results showed that only one domestic product met the requirements of CNS 14774 (T5017): 2003. Those samples which failed to meet the standard were sent to the local health authorities for penalty according to Pharmaceutical Affairs Act.