Information on the effectiveness of surgical face masks and other protection systems for reducing the risk of infection is still limited: we have analysed and outlined the main indications of production and use of these protection measures, indicating the legislative references and standards enacted as of 10 April 2020.
Surgical masks produced in conformity with UNI EN 14683:2019 – Medical face masks – Requirements and test methods and tested in conformity with UNI EN ISO 10993-1:2010 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process:
Subdivided into: Type I, Type II, and Type IIR.
These devices can be produced and marketed in exemption of the current provisions in force (products not bearing the CE mark), pursuant to Decree Law n. 9 of 2 March 2020 (Art. 34, paragraph 3) and Decree Law n. 18 of 17 March 2020 (Art. 15, paragraph 2), by request made to the ISS.
These devices can be produced and marketed in exemption of the current provisions in force (products not bearing the CE mark), pursuant to Decree Law n. 9 of 2 March 2020 (Art. 34, paragraph 3) and by Decree Law n. 18 of 17 March 2020 (Art. 15, paragraph 3), by request made to the INAIL..
The PPE can be used in case “workers are objectively prevented from maintaining the interpersonal distance of one metre, in conformity with the provisions of Italian Lgs. Decree n. 81 of 9 April 2008 (Art. 74, paragraph 1).
For more information, see: “ISS Environment and Indoor Air Quality Task Force. Indications for the prevention and management of indoor environments in relation to the transmission of infection by the SARS-CoV-2 virus. Version dated 23 March 2020. Rome: Istituto Superiore di Sanità (Italian National Institute of Health ); 2020. (ISS COVID-19 Report, n. 5/ 2020)”.
For these products, the use of which is intended neither as PPE nor MD and therefore cannot be used neither by the workers for which the use of specific PPE is required, nor by health care workers during service, the application of the extraordinary procedures established by Article 15 is excluded, but the manufacturer must guarantee that the masks do not cause damage or represent an addition risk for the users according to their intended use established by the manufacturers themselves (Circular of the Ministry of Public Health 18 March 2020 n. 3572).
The use of collective protection measures is allowed as prescribed by the Circular of the Ministry of Public Health 18 March 2020 n. 3572. Concerning the use of face masks by the community, please see the document published by the ECDC (European Centre for Disease Control) “Using face masks in the community” dated 8 April 2020.
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