As respiratory protection and surgical face masks have different purposes, they fall under different directives because they must meet different criteria.


Respiratory protection is regulated under different EN standards depending on the type of protection. In healthcare, filtering half masks are the protection that is mainly used.

Level of protection

Standard for surgical mask, EN 14683: 2019

EN 14683: 2019 is the current European standard used for requirements of the standard of surgical masks. It is required that the supplier meets the requirements to be able to sell and distribute the mouth guard. The mouthguards are classified according to EN 14683: 2019 in two different types, type I and type II, according to bacterial filtration efficiency. Type I and type II are then divided according to whether the mask is splash-resistant or not, where type IR and IIR are classified as a splash-resistant protection and “R” means splash resistance.