EN 14683 2019 specifies the construction, design, performance, and testing requirements for medical masks that are intended to 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 120mm Hg. This allows for the testing to determine if the mask is capable of minimizing fluid transfer from the outer layers to inner layers as a result of a splash or spray.
What is 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
- 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