What are the benefits of EN 14683 Certification?

• To protect the patient from infective agents and,
• Additionally, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids or aerosols
• Filter the inhaled air protecting the wearer and some types also filter the exhaled air (protection towards the outside)
• Have levels recommended by the WHO (World Health Organization):
  • The FFP2 filters over 92% of the suspended particles
  • The FFP3 arrive at values equal to or greater than 98%;
• Being fit tightly to the face and worn correctly prevents from infectious agents
• Safe and secure for healthcare personnel as indicated by WHO during the situations like currently affected Pandemic COVID19.

What are the requirements of en 14683:2019?

• The medical face mask shall not disintegrate, split, or tear during intended use. In the selection of the filter and layer materials, attention shall be paid to cleanliness and materials that don’t react with chemicals and or infectious agents need to be chosen.
• The medical face mask shall have a means by which it can be fitted closely over the nose, mouth, and chin of the wearer and which ensures that the mask fits closely at the sides.
• Medical masks need to go through series of performance that include but not limited to; Bacterial filtration efficiency (BFE), breathability, splash resistance microbial cleanliness and biocompatibility.
• The product information must be specified on the packaging in which the medical face mask is supplied as per the Annex I of the Medical Devices Directive (93/42/EEC).

The following information shall be supplied in addition:

1. Number of this European Standard.
2. Type of mask

Who can get EN 14683 certification?

Medical Face Masks as per European standard EN 14683:2019 is a key protective equipment that is applicable to organizations which are involved in manufacturing, trading and reselling of medical or general personal protective equipments that are widely used in various industries.