European standard for medical face masks, mainly used to prevent the transmission of microorganisms, fluids, and particles between healthcare workers and patients.
Focuses on bacterial filtration efficiency (BFE) and breathability.
N95 Respirators:
Regulated under the NIOSH (National Institute for Occupational Safety and Health) standard 42 CFR Part 84 in the United States.
Designed for protection against non-oil-based airborne particles (e.g., dust, smoke, microorganisms), commonly used in industrial and medical environments.
Focuses on particle filtration efficiency (PFE), requiring at least 95% efficiency for 0.3-micron particles.
2. Testing Methods
EN 14683:
Bacterial Filtration Efficiency (BFE): Measures the mask's efficiency in filtering bacterial particles (typically around 3 microns in size).
Breathability: Assesses the airflow resistance for comfortable wear.
Splash Resistance: Tests the mask’s ability to block liquid splashes.
Microbial Cleanliness: Evaluates contamination levels on the mask.
N95 Respirators:
Particle Filtration Efficiency (PFE): Evaluates filtration efficiency for 0.3-micron particles, requiring a minimum of 95% filtration.
Breathing Resistance: Measures airflow resistance for both inhalation and exhalation.
Fit Testing: Ensures a tight seal against the wearer's face to prevent leakage.
3. Design and Intended Use
EN 14683 Medical Face Masks:
Primarily used to prevent the spread of microorganisms from healthcare workers to patients, such as in surgical settings.
Designed for comfort and splash resistance rather than high-efficiency filtration of airborne particles.
N95 Respirators:
Designed to protect the wearer from airborne particles, including dust, smoke, and viruses.
Focuses on high-efficiency filtration and a secure facial fit to ensure safety.
4. Certification Bodies
EN 14683:
Issued by the European Committee for Standardization (CEN) and applies to the European market.
Certified by medical device regulatory authorities in Europe.
N95 Respirators:
Certified by NIOSH under 42 CFR Part 84 in the United States.
Undergoes rigorous testing for filtration efficiency and fit.
5. Can They Be Used Interchangeably?
EN 14683 medical masks and N95 respirators serve different purposes and are not interchangeable:
For protection against airborne particles (e.g., viruses, dust), N95 respirators are the correct choice.
For preventing microbial transmission in surgical settings, EN 14683 medical masks are more suitable.
Conclusion
EN 14683 cannot be applied to N95 respirators, as their design, purpose, and testing standards differ significantly:
EN 14683 applies to medical face masks, focusing on bacterial filtration and splash resistance.
N95 respirators follow NIOSH standards, focusing on particle filtration and facial fit.
For assessing or selecting an N95 respirator, NIOSH 42 CFR Part 84 should be referenced instead of EN 14683.
