| If you verify your mask product(s) fall(s) within the definition of a medical device in accordance with Regulation (EU) 2017/745, then the standard DIN EN 14683:2019 "Medical face masks - Requirements and test methods" should be applied for your product. If you verify your mask as respiratory protection within the meaning of the PPE Regulation (Regulation (EU) 2016/425), your product should be complied with DIN EN 149:2009 "Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking". |
How about face mask which are neither surgical mask nor respirator mask?
The single-use mask (non-woven mask), fabric mask (woven mask) fall within the meaning of the Consumer Goods and Feedstuffs Code (LFGB) and the German Consumer Goods Ordinance (BedGgstV), is treated as consumer goods.
The evidence about quality of product can be the test report from 3rd party. CE mark is not permitted.
Contact with your testing Laboratory for their recommendation.
The requirement of chemical standard
- REACH Annex XVII - entry 43, Azo dyes - REACH Annex XVII - entry 72, Formaldehyde - REACH Annex XVII - entry 72, Disperse dyes - REACH Annex XVII - entry 45, 67 Flame retardant (OctaBDE, DecaBDE ) - REACH Annex XVII - entry 23, Total Cadimium - REACH Annex XVII - entry 63, Total Lead - REACH Annex XVII - entry 20: Organotin compound
| The requirement of quality
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