Norms
REGULATION (EU) 2017/745
-EN14683:2019+AC:2019 : Medical face masks - Requirements and test methods
-Type : II
-Bacterial Filtration Efficiency : ≥ 98 %
-ISO 22609:2004 : Test method for resistance against penetration by synthetic blood
-. : 80mmHg
-EN ISO13485:2016 : Medical devices - Quality management systems - Requirements for regulatory purposes