110年度市售及邊境查驗輸入醫用口罩之品質監測   全文下載

Quality Monitoring of Medical Masks from Domestics and Border Inspection in 2021

近年由於新冠肺炎疫情全球肆虐，國人出入公共場所均需配戴口罩，醫用口罩之品質及效能影響國人健康甚鉅。為保障我國民眾使用醫用口罩之品質及效能，本計畫針對100件市售醫用口罩及53件向食品藥物管理署申請查驗之輸入醫用口罩進行檢驗。依據CNS 14774「醫用面（口）罩」之性能規格及其指定之標準檢驗方法及各產品原查驗登記核准之檢驗規格進行檢驗。並依據CNS 15290「紡織品安全規範（一般要求）」進行偶氮染料、游離甲醛等背景值調查。檢驗結果13件市售醫用口罩不符合相關規範，由原抽樣單位進行核處；1件邊境輸入醫用口罩查驗不符合相關規範，由報驗義務人辦理退運或銷毀之，以確保市售產品品質。

In recent years, due to the global pandemic of COVID-19, people are required to wear a mask in public areas. In order to ensure the quality and efficacy of medical masks, which affect people’s health a lot, the Taiwan Food and Drug Administration examed 100 medical masks sampled from domestic market and 53 ones for which the obligatory border inspection was applied. Examinationss were performed according to the test methods and specifications listed in CNS 14774 for medical masks and for the registration of medical device license. The azo colorants and free formaldehyde was examined according to the test methods CNS 15290 safety of textiles (General requirements). The results showed that 13 domestic masks failed to meet the test specification of medical device license, and sent to the local health authorities for penalty to ensure the quality of commercially available products. One imported mask failed to meet regulations and shall be shipped back or destroyed by the obligatory inspection applicant.