• 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.

See our surgical masks ADULTS: Click Here

See our surgical masks KIDS: Click Here

See our FFP2 masks Adults: Click Here

Surgical masks are class I medical devices, for this type of medical device CE marking is required.

• Bacterial filtration efficiency (BFE)

• Breathability

• Splash resistance

• Microbial Cleaning (Bioburden)

• Biocompatibility

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