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|
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:
What are the Applicable Standards?
Do we have to involve a NOtified Body
Yes for FFP
No for Surgical masks