2012-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/650504摘要:日前國內醫用面(口)罩,經衛生署公告自96年7月14日起均須符合國家標準CNS 14774之性能規格要求,該標準中對於口罩濾材的過濾效率方面,規定必須同時符合細菌過濾效率(bacteria filtration efficiency, BFE)測試以及次微米粒子防護效率(particulate filtration efficiency, PFE)測試等二種方法的性能要求。就技術層面而言,不論是從相關文獻中或是過去的經驗得知,BFE測試方法,經常會因為許多相關的實驗參數(如:氣霧艙之長度及其溫濕度、生物氣膠之產生品質無相關規定等)不明確或不易控制,因此造成測試結果的再現性不佳;相對地,PFE測試方法是工業衛生上對於防塵防護具性能把關的手段,不只操作參數相對易於控制,而且在儀器設備的發展上也比BFE來得成熟。雖然最初BFE與PFE測試方法制訂的目的與意義並不相同,但是,就學理上而言,BFE與PFE都是在描述濾材的過濾效能,換句話說,對於同一塊濾材而言,其BFE與PEF值會根據相同的效率曲線在不同的條件加權下所表現出不同的結果,意即,BFE與PFE應該會有相當程度的相關性。因此,本計畫將完整檢視並經實驗証實細菌過濾效率檢測方法(BFE)之弱點與不方便性,並評估以物理性測試方式(PFE)取代BFE的可能性,一方面增加口罩性能測試的可靠度,另一方面可以大幅降低口罩濾材測試的儀器設備、人力技術的成本以及時間上的需求。<br> Abstract: According to the bulletin of the Department of Health on July 14, 2007, all surgical masks are required meet the National Standards, referred to as CNS 14774. The surgical masks must pass both bacteria filtration efficiency (BFE) test and particulate filtration efficiency (PFE) test.In theory, BFE test is prone to carry higher variation than PFE test does, because it involves biological process, which is likely to be influenced by many operating parameters, such as the microbial concentration in the stock solution, the environmental conditions of the test chamber, and size distribution of the microbial aggregates …etc.. In contrast, PFE test is relatively simple and less time-consuming. The PFE test equipment has long been developed and validated. However, detailed comparison of these two methods has never been performed and reported in the peer-reviewed journals. Therefore, one of the main objectives of this work is to compare these two test method in a more systematic and thorough way, and to check on whether it is feasible to use only PFE, not both BFE and PFE, for certification of surgical masks, if these two test results are highly correlated. The experimental apparatus will be set up according to the ASTM standards. A number of surgical masks with low filter efficiency will be acquired from local manufacturers or distributers of international brands. For purpose of field audit, the surgical masks will be purchased from stores and/or supermarkets.醫用口罩細菌過濾效率次微米粒子防護效率surgical maskbacteria filtration efficiencyparticulate filtration efficiencyProficiency Verification and Quality Assurance of Surgical Masks