EN 14683 Certification

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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 

What is the British standard for face masks?

BS EN 14683:2019 certification is the British Standard for face masks in compliance with the requirements. It is specifically designed for the healthcare specialist to safeguard them from the infected patient. These masks are medically safe to use and also take into account harmful bacterial filtration which can cause serious issues.

What is EN 14683 type IIR mask?

BS EN 14683:2019 certification is the British Standard for face masks in compliance with the requirements. It is specifically designed for the healthcare specialist to safeguard them from the infected patient. These masks are medically safe to use and also take into account harmful bacterial filtration which can cause serious issues.

What is the aim of EN 14683 Certification?

Right from the outbreak of Covid-19 pandemic, the demand for EN 14683 Certification has multiplied. EN 14683 is a globally recognized standard that gives assurance to your organization that you are producing an excellent quality face mask complying with all the requirements. It also assures your customer that the masks you manufacture are medically tested and approved for both medical and private use.

What is the latest version of EN 14683 Certification?

EN 14683: 2019 certification is the latest version of EN 14683 standard which ensures that your company is meeting all the requirements in delivering quality assured medical face mask. Having this certification will prove that your products are medically tested products.

Is EN 14683 certification right for me? / Why become EN 14683 certified?

Having an EN 14683 certification is crucial for any organization because it marks your business as an effective, efficient, and resilient, in delivering medically proven face mask which will help you to win new opportunities in the business field. It also helps you to demonstrate how committed you are in delivering quality assured masks and how you are trying to meet the customer’s expectations.

How can I get an EN 14683 certificate?

Achieving EN 14683 Certification is not a big deal in today’s upgraded systems. The basic steps to become EN 14683 Certified are listed below:

  • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
  • Secondly, you need to document all the relevant information about your business.
  • Thirdly, you have to implement all the documented information in your organization.
  • Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
  • Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

Much does it cost for EN 14683 certification?

The cost of EN 14683 certification varies from one organization to another. Basically, when you approach an internationally accredited certifying body for EN Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving EN certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

How long is an EN 14683 certificate valid for?

Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

How do I maintain EN 14683 certification?

Just because you received an EN 14683 certification, your task is not complete. For proper functioning of the management system, you need to maintain the EN 14683 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

  1.  How can I apply for EN 14683:2019 for my company?
  • First of all, you need to choose an internationally accredited certification body meeting all the requirements of ISO Accreditation such as SIS CERTIFICATIONS.
  • Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar.
  • After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization.
  • The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps.
  • Then, there will be initial certification audits which will be followed by:
    • Stage I – where the auditors will check the changes made in your organization according to requirements.
    • Stage II – where the auditor will do their final audit for the certification.
  • As the auditors will approve all your processes then they will make a report and send it to the registrar. They will then grant you the EN 14683 certification.

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