The mandatory CE certification for mask exports to Europe is required. Masks are PPE personal protective equipment, and mask products need to pass the European CE mark. The new (EU) 2016/425 directive on PPE (old 89/686/EEC directive) complies with relevant standards.
EN 136 Full face hood - Category 1, 2 or 3.
EN 136:1998 Respiratory protective devices - Full face masks - Requirements, testing, marking
EN 140 Half Face Mask/Quarter Face Mask
EN140:1998/AC:1999 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking
EN 143 particulate filter
EN143:2000/A1:2006 Respiratory protective devices - Particle filters - Requirements, testing, marking
EN 149 Filter type half face mask for particle protection
EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
EN 14387 Air filters and combination filters
EN14387 :2004+A1:2008 Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking
Mask level: FFP1 filtration rate greater than 80%, FFP2 filtration rate greater than 94%, FFP3 filtration rate greater than 99%
Mask factories require ISO 13485 certification
ISO13485 Medical Device Quality Management System Standard
