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Mask CE Certification
Mask CE Certification Regulations and Processes
The EU divides masks into two categories according to their purpose: personal protective masks and medical masks.
1. Personal Protective Masks
Personal protective masks are not medical devices, but they must meet the requirements of the European Union Personal Protective Equipment Regulation EU2016/425 (PPE), and the authorized notified body will carry out CE certification and issue a certificate. The corresponding standard is EN149.
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 structures, bacterial filtration efficiency, differential pressure, resistance to penetration by synthetic blood, microbial indicators, biocompatibility.
