Surgical half masks have the purpose of preventing the wearer from contaminating the environment, as they limit the transmission of infectious agents and fall within the scope of medical devices under Legislative Decree 24 February 1997, n.46 and subsequent amendments and supplements.
With the Decree-Law 17 March 2020 n.18, the surgical half masks (DM – Medical Device) available on the market are equated to DPI (Individual Protection Devices).
They are produced in compliance with the technical standard UNI EN 14683:2019, which provides characteristics and test methods, indicating the requirements of
- resistance to liquid splashes
- bacterial filtration efficiency
- cleanliness from microbes
The technical reference standard UNI EN ISO 10993-1:2010 has a general character for medical devices and provides for evaluation and testing within a risk management process.
CE marked – Conforms to Directive 93/42/EEC and subsequent amendments.