Protection systems
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 systems, indicating the legislative references and standards enacted as of 10 April 2020.
SURGICAL FACE MASKS
MD (Medical Devices) – 2017/745/EU
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.
FACE MASKS FFP1 / FFP2 / FFP3 and others PPE – 2016/425/EU
- Eye protection – UNI EN 166:2004 – Personal eye-protection – Specifications
- Respiratory protective devices – UNI EN 149:2009 and UNI EN 140:2000
- Protective clothing – UNI EN 14126:2004 and UNI EN 13688:2013
- Hand protection – UNI EN 420:2010, UNI EN ISO 374-5:2017, UNI EN ISO 374-2:2020 e UNI EN 455
- Lower limb protection UNI EN ISO 20345:2012, UNI EN ISO 20346:2014 and UNI EN ISO 20347:2012
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)”.
Collective protection systems
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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