Original Articles
14 February 2025
Vol. 42 No. 2 (2020)

VALIDATION OF SURGICAL MASKS DURING COVID19 EMERGENCY: ACTIVITIES AT THE UNIVERSITY OF NAPOLI FEDERICO II

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During COVID-19 pandemic crisis, Italian Government has approved Law Decree no. 18 of 17 march 2020, in which art. 15 allows enterprises to produce, import and commercialize surgical masks notwithstanding the current rules of product certification. It is just required that the interested enterprises send to the Italian National Institute of Health a selfcertification in which they declare the technical characteristics of the masks and that masks are produced according to the safety requirements.
In this context, a technical-scientific unit was established at the University of Napoli Federico Il to provide interested enterprises with state-of-the-art consultancy, testing and measurement services, adhering to rigorous scientific protocols.
Characterization tests were carried out on 163 surgical masks and or materials for their construction and they have enabled the identification of pre-screening criteria to simplify the procedure for evaluating surgical masks using methods for assessing the filtration efficiency of particles and aerosols.
Based on experimental results, it has been observed that a filtration efficiency for particles with sizes larger that 650 nm (PFE,650) exceeding 35% might guarantees a bacterial filtration efficiency (BFE) higher than 95% while BFE values higher than 98% are obtained when the PFE >650 is larger than 40%. PFE measurement is extremely simpler with respect to BFE, the latter being time-consuming and requiring specific equipment and methods for its realization.
Many tested materials have shown the capability to assure high filtration efficiencies but Spundonded-Meltblown-Spunbonded (SMS), that are layers of non-woven fabric with different weights of Meltblown, can simultaneously guarantee high particle filtration efficiencies with pressure drop values (breathability) in the limits to classify the surgical masks as Type I/IIR. In fact, the fabric products analyzed so far have not been able to simultaneously guarantee adequate BFE and breathability values. On the contrary, Spunbonds of adequate weights can virtually verify both requirements and accredit themselves as possible materials for the production of surgical masks, at least of Type I. Further studies are needed to verify the possibility of producing low-cost, reusable surgical masks that could meet the criteria of circular economy.

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Citations

1) Decreto-Legge 17 marzo 2020, n. 18 "Misure di potenziamento del Servizio sanitario nazionale e di sostegno economico per famiglie, lavoratori e imprese connesse all'emergenza epidemiologica da COVID-19" pubblicato sulla Gazzetta Ufficiale Serie Generale n. 70 del 17 marzo 2020.
2) UNI EN 14683: 2019. Maschere facciali ad uso medico - Requisiti e metodi di prova.
3) ISO 22609:2004. Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected).
4) UNI EN ISO 10993-1:2010. Valutazione biologica dei dispositivi medici - Parte 1: Valutazione e prove all'interno di un processo di gestione del rischio.
5) UNI EN ISO 10993-5:2009. Valutazione biologica dei dispositivi medici - Parte 5: Prove per la citotossicità in vitro.
6) European Pharmacopoeia (Ph. Eur.) 10th Edition, 2019.
7) UNI EN 13274-7:2019. Dispositivi di protezione delle vie respiratorie - Metodi di prova - Parte 7: Determinazione della penetrazione dei filtri antipolvere.
8) UNI EN 149:2009. Dispositivi di protezione delle vie respiratorieSemimaschere filtranti antipolvere - Requisiti, prove, marcatura. 9) Politecnico di Milano Nota tecnica v 5.0 del 04/05/2020 consultato in data 30 maggio 2020 al sito: https://www.regione.lombardia.it/ wps/wcm/connect/0c81f5f1-ef90-4417-afe2-8d659c21b4ab/ NOTA+TECNICA +2-1+-+Scheda+materiali+approvati.pdf?MOD =AJPERES&CACHEID=ROOTWORKSPACE-0c81f5f1-ef904417-afe2-8d659c21b4ab-n4n8iMs
10) Chapman, R.A., Applications of nonwovens in technical textiles, Woodhead Publishing Series on Textiles n. 102, Woodhead Publishing, Cambridge (UK) 2010.

How to Cite



VALIDATION OF SURGICAL MASKS DURING COVID19 EMERGENCY: ACTIVITIES AT THE UNIVERSITY OF NAPOLI FEDERICO II. (2025). Giornale Italiano Di Medicina Del Lavoro Ed Ergonomia, 42(2), 73-81. https://doi.org/10.4081/gimle.442