手術衣及外科用覆蓋巾體液防護試驗之品質監測   全文下載

Survey on the Quality of Fluid Resistance of Surgical Gown and Surgical Drapes in Taiwan

為了解手術衣及外科用覆蓋巾體液防護品質之現況，本計畫委請各地方政府衛生局針對轄區內製造業者或代理商及各級醫療院所等地進行抽驗。共抽得手術衣8件及外科用覆蓋巾10件，其中國產品13件，輸入品5件。檢體分別參考106年12月13日FDA器字第1061609014號公告修正之「外科用覆蓋巾臨床前測試基準」、原廠規格、AATCC 42、AATCC 127及ASTM F1670等方法進行衝擊穿透、靜水壓、抗合成血液穿透性試驗等體液防護功能測試，檢驗結果15件符合原查驗登記規格，2件手術衣未達仿單宣稱液體防護等級3之性能要求，1件外科用覆蓋巾其規格超出原核定範圍，相關檢驗結果提供原抽樣單位進行核處，期能確保市售產品品質，保障病患及醫護人員之健康安全。

In order to investigate the quality compliance of surgical gowns and surgical drapes, 18 samples were sampled from manufacturers, importers or hospitals by local health authorities in Taiwan area for post-market testing in 2020. According to the test methods of specification of each product, the performances of impact penetration test, hydrostatic pressure test and the resistance to penetration by synthetic blood, samples were tested by contracted laboratories. The results showed that 15 products followed the specifications while 3 products did not. The reports of failed products were sent to the local health authorities for penalty to ensure the quality of products.