SS-EN 14683: 2019 is the current European standard used for requirements of the standard of surgical mask. This face mask is classified according to SS-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 mouth guard is splash-resistant or not, where type IR and IIR are classified as a splash-resistant protection and “R” means splash resistance.
Type I and type II are tested according to three different test methods:
- Bacterial filtration efficiency (BFE)
- Respiratory resistance (differential pressure, DP)
- Microbial cleanliness
Type IR and IIR are tested, including the three mentioned, also with a fourth method which is splash resistance pressure.
|Class||Bacterial Filter Efficiency (BFE)||Respiratory resistance (DP)||Splash resistance (mmHg)|
Surgical masks do not require the same labeling requirements as respiratory protection. The product does not need to be labeled at all. The packaging of surgical masks must be marked with the CE marking in accordance with the Medical Equipment Directive 93/42 class 1. The CE marking of surgical masks is not accompanied by a combination of numbers and does not have an approval / registration number from a notified body.