Medical face masks are a critical part of protective equipment in healthcare. Among various types of safety masks, the EN14683 standard ensures that your medical masks provide consistent protection against contamination.
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.
European Market Classification: Understanding Type I, II, , IR and IIR
The EN14683 standard ensures that your medical masks provide consistent protection against contamination. For the EU market, masks are categorized based on their performance levels:
- 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
To better understand the differences between the highest-grade medical masks, here is a quick comparison:
| Feature | Type II Mask | Surgical Mask Type IIR |
|---|---|---|
| Bacterial Filtration (BFE) | > 98% | > 98% |
| Splash / Fluid Resistance | No | Yes (≥ 120 mm Hg) |
| Best For | General clinical areas | Operating rooms, ERs |
| Standard Design | Ear loops | Ear loops or Tie surgical mask |
Pro Tip: For long surgical procedures, a tie surgical mask is often preferred by surgeons for a more secure, adjustable fit compared to standard ear loops.
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.
Understanding EN14683 Testing: From BFE mask efficiency to Fluid resistance mask requirements
The EN 14683 standard is a performance-based benchmark. To maintain compliance, manufacturers must undergo rigorous EN14683 testing in accredited laboratories.
The testing process evaluates several key factors:
- Bacterial filtration efficiency (BFE) test: This test measures the BFE mask 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. This is vital for a fluid resistance mask, ensuring that sudden splashes of bodily fluids in an operating room cannot pass through the mask and endanger the wearer.
- 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.
What’s Changing in EN 14683:2025?
To bridge the gap between “what it is” and “what is coming,” professionals must acknowledge the 2025 revisions. The updated standard focuses on:
- Refined Bioburden Calculations: New methods for determining microbial cleanliness, requiring results to be extrapolated to the whole mask.
- Stricter Accuracy for Testing Instruments: Enhanced manometers and flow meter requirements to ensure more reliable EN14683 testing results.
- Transition to Pascals (Pa): Moving away from Pa/cm² to simplify global breathability benchmarks.
Manufacturers failing to update their documentation to the 2025 standards risk losing their CE certification and market readiness.
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
