CE Marking for Face mask
Two types of EU legal Frameworks applicable for Face masks are:
Face Mask type | Directive /Regulation | Standard | NB involvement | Testing Required |
Surgical masks | Regulation (EU) 2016/425 | EN 14683 | Not Needed | By Independent Lab |
Face mask | Regulation (EU) 2017/745 | EN 149+ EN 14683 | In Design Examination | By NB laboratory |
Face Mask Certification as PPE
Can we Get Standards for Free?
Yes, manufacturers can download the standards EN 149 and EN 14683 for free from the online catalogs of the national standardization bodies. A full list, with links to the respective web-sites, is available at:
https://standards.cen.eu/dyn/www/f?p=CENWEB:5.
What are the Applicable Standards?
- EN 149
- EN 14683
Do we have to involve a Notified Body?
- Yes, for FFP
- No, for Surgical masks