Disposable masks | 合法醫療器材資訊網
由JCRubio-Romero著作·2020·被引用90次—TheWHOstilldoesnotrecommendtheuseofmasksforthegeneralpopulation....hightemperature,autoclaveorsteamarenotfullyrecommended....thereuse,cleaninganddisinfectionofcertifieddisposable
Additionally, European healthcare systems use disposable medical or surgical masks, which are not PPE but “surgical/medical apparatus and devices”, which are standardized by EN 14683:2019 + AC:2019 “Medical face masks - Requirements and test methods” (UNE, 2019[1]) (see ). As in the case of PPE, there are also different certifications in other countries such as ASTM F2100-11 in the United States or YY 0469 in China.
Due to the public health threat caused by SARS-COV-2, there has been a lack of disposable masks certified to meet European technical standards. In this situation, the European Commission published the Commission Recommendation (EU) 2020/403 of March 13, 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat to allow, as long as the shortage lasts, the commercialization of PPE or medical devices that comply with non-European standards even if t...
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Hi+Clean醫級淨醫療口罩(未滅菌) Hi | 合法醫療器材資訊網
Hi+Clean醫級淨醫療口罩(未滅菌) Hi | 合法醫療器材資訊網
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【Hi+Clean醫級淨 醫療口罩 (未滅菌)】許可證字號:衛部醫器製壹字第006325號
器材品名:Hi+Clean醫級淨醫療口罩(未滅菌)許可證字號:衛部醫器製壹字第006325號註銷狀態:註銷日期:註銷理由:有效日期:2021/0...