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.

Certificate Description
en-136 EN 136
Full mask
EN-140 EN 140
Half mask
En-149-2001 EN 149:2001
Filtering half masks for protection against particles, suitable for both solid and / or liquid particles. EN 149 + A1: 2009 is a European standard for respiratory protection. The standard places demands on both the product and the manufacturer.

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.

Certificate Description
146 EN 14683:2014
Surgical mask