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USA@Hohenstein.com

Face masks provide effective respiratory protection from environmental conditions such as problematic aerosols in the workplace or from infections in healthcare and nursing. In everyday life, high-quality cloth face coverings such as "community masks" can help control the spread of diseases.

Depending on the specific area of application, face masks must meet high quality requirements. As an accredited test laboratory for medical devices and a notified body (No. 0555) for the certification of personal protective equipment, Hohenstein tests medical face masks according to DIN EN 14683 and FFP respiratory masks according to DIN EN 149. For everyday face masks, we test according to CWA 17553:2020 and award the Hohenstein Quality Label.

We test face masks.

PPE

Requirements:

  • EU Regulation 2016/425 for Personal Protective Equipment
  • EU standard EN 149
  • CE certification label

Use:

  • Protection of wearer (e.g. medical/care staff) from breathing in infectious aerosols (airborne pathogens) or dust from patients or the environment
  • Protection levels for respiratory masks (FFP 1-3) depend on how well they protect from dust, liquid or solid particles and pathogens
Medical

Medical Masks

AKA surgical/oronasal

Requirements:

  • EU Medical Device Regulation 2017/745
  • EU standard EN 14683

Use:

  • Protection of environment from contaminated droplets from potentially infected wearer
  • Protection of wearer from splattered infectious bodily fluids (e.g. during surgery)
  • Restricted protection of wearer from smear infection via contaminated hands touching the mouth and nose
Cloth

Community Masks

AKA DIY, everyday, cloth

Requirements:

  • EU Standard CWA 17553:2020,
  • Minimum performance, design, packaging labeling, use, harmful substances

Use:

  • Private use
  • NOT applicable to medical device or protective equipment

Beyond Compliance

Contact
Ben Mead
Managing Director
Hohenstein Americas