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CE Marking of Face Mask

CE marking for Face mask

Two types of EU legal Frameworks applicable for Face masks are:

Face Mask typeDirective /RegulationStandardNB involvementTesting Required
Surgical masksRegulation (EU) 2016/425EN 14683Not Needed

 

By Independent Lab
Face maskRegulation (EU) 2017/745EN 149+ EN 14683In Design ExaminationBy 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 catalogues of the national standardisation 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

 

 

Ce marking for Face mask under PPE

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