Traditionally, masks have fallen into two categories – medical face masks (such as surgical masks), which fall under the medical
device regulations, and protective masks (such as particle filtering half masks) that are applicable to personal protective equipment (PPE) regulations. Given the COVID-19 pandemic, a third category of mask is emerging.
A reusable face mask, also referred to as a “barrier mask” or “community face covering”, is designed specifically as a means to
control the spread of COVID-19. Neither a medical device nor recognized as PPE, these reusable masks have recently been classified into their own group and been determined the requirements that they should meet.
EN 14683 is the
primary EU standard for medical face masks. Within the standard there are three types of masks: Type I with Bacterial Filtration
Efficiency (BFE) > 95% mainly for patient use, type II with BFE > 98% and Type IIR with splash resistance.
For the re-usable fabric masks there is CEN guidance: CWA 17553:2020 Community face coverings - Guide to minimum
requirements, methods of testing and use, that covers the planning, manufacturing and testing of the masks. The guidance
includes also materials, washing and required instructions for use.
- SUB-MICRON PARTICULATE FILTRATION EFFICIENCY (PFE)
- BREATHABILITY – EN 14683 ANNEX C
- BACTERIAL FILTRATION EFFICIENCY (BFE) – EN 14683 ANNEX B
- SPLASH RESISTANCE – ISO 22609
- PERFORMANCE REQUIREMENTS FOR MEDICAL FACE MASKS (TYPE I a TYPE II TYPE IIR)
- Particle filtering half masks (FFP2/FFP3) according EN 149. Category lll equipment as per the Regulation (EU) 2016/425 personal protective equipment (the PPE regulation). PENETRATION OF FILTER MATERIAL; BREATHING RESISTANCE
- REUSABLE FABRIC MASKS: FILTRATION – PFE AND BFE; FILTRATION - DGA ANNEX 2 HOLI POWDER; BREATHABILITY - ISO 9237; FLANGE GAME RESISTANCE TEST