Norma UNI EN 14683 Medical Face Masks - Requirements and Test Methods: is a harmonized standard (provides presumption of conformity).
UNI EN ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process: is general in nature for medical devices and provides for evaluation and testing within a risk management process.
Medical Device Directive 93/42/EEC (to be replaced in the future by regulation (eu) 2017/745 of the european parliament and of the council of 5 april 2017).
UNI CEI EN ISO 13485 Medical Devices - Quality Management Systems - Requirements for regulatory purposes is harmonized with the European Medical Device Directive: Medical Device Directive 93/42/EEC.
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Surgical masks are class I medical devices, for this type of medical device CE marking is required.
Bacterial filtration efficiency (BFE)
Microbial Cleaning (Bioburden)
Directive concerning medical devices (93/42/EEC) or Regulation (EU) 2017/745 concerning medical devices specifies the information that should be specified on the packaging in which the face mask for medical use is supplied.
The following information must be provided:
a) number of this European Standard
b) mask type (I, II o IIR)
All our masks are CE certified and comply with the standards for the production (not derogated) in the national territory.
CE CERTIFICATION (Downloadable): View Certificazione CE FAYYIA
FFP2 CERTIFICATION (Downloadable): View FAYYIA FFP2 Certification
TEST REPORT (Downloadable): View Test Report FAYYIA