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Mascarillas en el contexto de la COVID-19: aspectos legales y utilizacion #MMPMID34218765
Fraga-Garcia M; Nacher-Alonso A; Diez-Sales O
Farm Hosp 2021[May]; 45 (4): 193-197 PMID34218765show ga
OBJECTIVE: The objective of this article is to review the quality equirements and recommended uses of the different types of face masks with a view to helping optimize their use and facilitating identification of nonconforming products. METHOD: A literature search was conducted in PubMed, the Spanish Official State Gazette and Eudralex. The websites of the Ministry of Industry, Commerce and Tourism and of the Ministry of Health, as well as the relevant UNE standards were also reviewed. RESULTS: The different types of face masks available on the market meet different regulatory requirements. Community masks are not considered medical devices or personal protective equipment and do not require marketing authorization. They do not carry a CE mark and need not comply with the general regulations applicable to consumer products. Surgical masks, for their part, must meet the quality criteria defined in UNE-EN standard 14683: 2019. According to Regulation (EU) 745/2017 they are class I devices, subject to an EU declaration of conformity, and must bear a CE mark. Filtering masks are considered category III personal protective equipment, regulated by Regulation (EU) 2016/425, and must also bear a CE mark. In spite the abundant regulations in place, market control instruments have detected counterfeit face masks, which means that public authorities and users should ask manufacturers or suppliers for additional information in case of doubt. CONCLUSIONS: The legal and quality requirements of the masks are sufficient for their safe use. It is necessary for the general public to know these requirements to avoid the fraudulent use of high consumption products.
Farm+Hosp 2021 ; 45 (4): 193-197
