Surgical masks

Surgical masks are designed to prevent the wearer from contaminating the environment , as they limit the transmission of infectious agents and fall within the scope of medical devices pursuant to Legislative Decree no. 46 of February 24, 1997, as amended. They are used in hospitals and in places where assistance is provided to patients (for example health homes, clinics, etc.).

To be safe, surgical masks must be produced in compliance with the technical standard UNI EN 14683: 2019 (which can be downloaded for free from the website ), which provides features and test methods, indicating the requirements for:

  • resistance to liquid splashes
  • breathability
  • bacterial filtration efficiency
  • cleaning from microbes.

The technical standard of reference UNI EN ISO 10993-1: 2010 (downloadable free of charge from the site ) has a general character for medical devices and provides for assessment and tests within a risk management process .