Surgical masks
The surgical 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 the medical devices. That refers to Italian Legislative Decree no. 46 of 24th February 1997. Surgical masks are used in hospital environment 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 provides characteristics and test methods, indicating the requirements of:
- liquid splash resistance
- breathability
- bacterial filtration efficiency
- cleaning by microbes
The reference technical standard UNI EN ISO 10993-1: 2010 is general in nature for medical devices and provides assessment and tests within production process.