EN14683 2019 specifies the construction, design, performance, and testing requirements for medical masks that prevent infective agents from being transmitted from patients to staff during medical settings. An appropriate microbial barrier for medical masks can be used to reduce the transmission of infective agents from the mouth and nose of an asymptomatic carrier, or a patient suffering from clinical symptoms.
There are three types of surgical masks for EU Market:
- Type I: Bacterial filtering effectiveness > 95%.
- Type IR: Bacterial filtering effectiveness > 95%, splash-resistant
- Type II: Bacterial filtering effectiveness > 98%.
- Type IIR: Bacterial filtering effectiveness > 98%, splash-resistant
What does the R stand for?
- R = Fluid Resistance
Fluid resistance is the ability of the surgical mask to reduce fluid transfer from outer layers to inner layers as a result of splashes or sprays. EN14683 recommends that fluid resistance be tested with synthetic blood at pressures of 120mm Hg. This allows the testing to determine if the mask can minimize fluid transfer from the outer layers to the inner layers as a result of a splash or spray.
EN 14683 – a performance-based standard
The EN 14683 standard is a performance-based standard, which means that the mask is required to meet certain performance requirements in order to be compliant with the standard. In order to demonstrate compliance with the standard, manufacturers of medical face masks must perform testing on the masks to ensure that they meet the required performance criteria.
The testing process for EN 14683 includes several different tests, including:
- Bacterial filtration efficiency (BFE) test: This test measures the mask’s ability to filter out bacterial particles.
- Differential pressure test: This test measures the resistance of the mask to airflow.
- Synthetic blood penetration test: This test is only required for Type IIR masks, and it measures the mask’s resistance to penetration by synthetic blood.
- Microbial cleanliness test: This test measures the level of microbial contamination on the mask.
Manufacturers of medical face masks must also provide documentation to demonstrate that the masks meet the requirements of the standard, including detailed information about the materials used, the design of the mask, and the results of the testing. This documentation is typically submitted to a third-party certification body, which will review the information and issue a certificate of conformity if the mask meets the requirements of the standard.
About ISO 11737-1
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 11737-1-2018 outlines requirements and provides guidance for the enumeration of viable microorganisms in health care products, components, raw materials, and packages. Microbial cleanness test must have a result of <30cfu/g in order to pass EN14683.
To understand the following terminology, please check this ASTM standard article for a detailed explanation.
- BFE (Bacterial Filtration Efficiency)
- Fluid Resistance
- Delta P (Pressure Differential)
- Spread the Flame
- ISO Certification
Take Home Message
It is important to note that the EN 14683 standard is a performance-based standard, which means that the mask must meet certain performance requirements in order to be compliant with the standard. It is not a guarantee that the mask will provide a certain level of protection against infection. The effectiveness of a face mask also depends on factors such as fit, proper use, and proper maintenance.
Reference
- BS EN 14683:2019. (2019, August 22). Techstreet. https://www.techstreet.com/standards/bs-en-14683-2019?product_id=2040329
- Nelson Labs – Microbiology Testing Lab. (n.d.). Nelson Labs. Retrieved August 18, 2021, from https://www.nelsonlabs.com/
- CEN – Technical Bodies –. (n.d.). Standards. Retrieved August 18, 2021, from https://standards.cen.eu/dyn/www/f?p=204:32:0::::FSP_ORG_ID,FSP_LANG_ID:,25&cs=16ADA26AC67187F3D3331D89E662D8BA8
