EN 14683 Certification

EN 14683

WHAT IS EN 14683 CERTIFICATION?

Ever since the outbreak of Covid-19 pandemic, face masks have been hailed as the most important defence against the virus. Various studies have claimed the effectiveness of face masks in reducing the transmission of virus in the masses. However, the masks are needed to be made as per certain standards in order to ensure their efficiency. EN 14683 certification is specifically designed for constructing face masks that can protect the wearer from droplets of the people in their vicinity. In general, there are three types of surgical masks:

  • Type I: bacteria filtering effectiveness > 95%.
  • Type II: bacteria filtering effectiveness > 98%.
  • Type IIR: bacteria filtering effectiveness > 98% and splash-resistant.

BENEFITS OF EN 14683:2019

  • The masks made using this standard protects the individual from infective agents, such as contaminated liquid droplets or aerosols.
  • These masks are effective in filtering the inhaled as well as exhaled air.
  • The filtration levels of the masks are as per the recommendations of WHO (World Health Organization):
    • FFP2- filters >92% of the suspended particles
    • FFP3- filters > 98% of the suspended particles
  • It ensures that the masks are well-fit to the wearers, preventing significant chance of contamination.
  • These masks are absolutely suitable for the frontline healthcare professionals, as it covers all the guidelines recommended by WHO.

REQUIREMENTS OF EN 14683:2019?

  • The masks should be resilient against disintegration, tearing-off or spoilage at the time of use. Special care must be taken while selecting filter and layer materials- they should be clean and non-reactive to chemicals.
  • The masks should be able to fit properly to the wearer- they should enclose the nose, mouth, and chin of the wearer and must leave no gaps from the sides.
  • There are several performance tests that the medical masks are required to undergo. These include the tests related to Bacterial filtration efficiency (BFE), splash resistance, breathability, microbial cleanliness, biocompatibility, and a lot more.
  • The packaging of face masks must include the specifications about the product. This is as per the Annex I of the Medical Devices Directive (93/42/EEC).

In addition to that, the following information must be provided:

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

WHO CAN APPLY FOR EN 14683 CERTIFICATION?

Any organization, involved in the manufacturing, trading or retailing of the medical masks and other protective equipment can apply for EN 14683 standard. This European standard for medical face masks is applicable to organizations irrespective of their sizes.

If you are looking for EN 14683 certification or want to learn more about it, get in touch with the team of SIS Certifications.

Here’s a short video about what we are and what our services are all about- SIS CERTIFICATIONS 

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