1. Personal protective masks
Personal protective masks are not medical devices, but they must meet the requirements of the EU Personal Protective Equipment Regulations EU2016/425 (PPE).
2. Medical masks
Medical masks correspond to standard 93/42/EEC (MDD) or EU Medical Device Regulation EU-2017/745 (MDR) and affix the CE mark, and the corresponding standard is EN14683;
Medical sterile masks: CE certification must be carried out by an authorized agency;
Medical non-sterile masks: Enterprises need to make a CE self-conformity declaration.
Mask Test Project (EU Regulation)
EN149:2001+A1:2009 Respiratory protective equipment Self-priming filter type anti-particulate respirator main test items:
• Visual Inspection, NaCl Filtration Efficiency, Oily Filtration Efficiency, Dead Space, Field of View, Headband, Connections and Connecting Parts, Flammability.
EN 14683:2005, EN 14683:2019 Main test items for medical surgical masks:
• Materials and construction, bacterial filtration efficiency, differential pressure, resistance to penetration by synthetic blood, microbial indicators, biocompatibility.