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BS EN 14683:2019 – Medical Face Mask – Requirements and test methods
The BS EN 14683 standard assesses the quality and performance of medical face masks. This standard ensures that masks prevent the spread of infectious agents between patients and healthcare providers, particularly in high-risk environments such as operation theaters. By providing the standard requirements for testing bacterial filtration efficiency, breathability, splash resistance and microbial cleanliness, EN 14683 ensures that face masks deliver reliable protection, comfort and durability.
Products Tested at MIS
Medical face masks that come within the scope of EN 14683 are classified into the following two groups, Type I and Type II, based on their Bacterial Filtration Efficiency (BFE).
Type I medical face masks are intended for use by patients and other general people to minimize the risk of spread of infection, particularly during epidemic or pandemic situations.
Type II medical face masks are primarily intended to be used by healthcare professionals in operating rooms or other similar situations/ requirements. Type II masks are further categorized into Type II R (R signifies splash resistance) depending on whether the mask is splash-resistant or not.
According to EN 14683 standard, the following tests are carried out on finished products or samples cut from finished products.
- Bacterial filtration efficiency (BFE)
- Breathability (delta P)
- Splash resistance (synthetic blood)
- Microbial cleanliness
- Biocompatibility
EN 14683 Test Methods
Bacterial Filtration Efficiency (BFE) Test
The BFE test is performed to determine the resistance of the mask materials and components to bacterial penetration.
Test requirements and conditions
Mandatory test microorganisms: Staphylococcus aureus (ATCC 6538).
Test specimen preparation
- Five test specimens, each measuring 100 mm × 100 mm, are required for testing.
- Test specimens should include all layers of the mask in the order they are arranged in the finished product.
- Before testing, each test specimen should be conditioned at (21 ± 5) °C and (85 ± 5) % relative humidity for at least 4 hours to bring them into equilibrium with the atmosphere.
Test Procedure
- A specimen of the recommended size is clamped between a six-stage cascade impactor and an aerosol chamber.
- The aerosolized bacterial suspension (Staphylococcus aureus) is introduced into the aerosol chamber and drawn through the mask material and the cascade impactor under vacuum.
- The Petri plates in the cascade impactor collect any aerosolized bacteria that pass through the mask material.
- This procedure is repeated for each test specimen, with fresh plates placed in the cascade impactor for each test.
- After all test specimens are tested, a positive control (untreated mask material) and a negative control test are performed.
- All the plates are incubated at 37 °C for 20 to 52 hours.
- After incubation, viable bacteria from the agar plates are enumerated and reported in terms of colony-forming units (CFU). For each specimen, the bacterial filtration efficiency is calculated and expressed as a percentage.
Breathability (differential pressure) Test
This test assesses the breathability of mask materials, specifically evaluating whether wearers can breathe comfortably while wearing them. The breathability of the mask is assessed by measuring the pressure difference (also called “pressure drop”) across two sides of a mask.
Test specimen preparation
- 5 test specimens with a circular test area of 25 mm in diameter are required for testing. These specimens should include all layers of the mask as they are arranged in the finished product.
- Before testing, each test specimen should be conditioned at (21 ± 5) °C and (85 ± 5) % relative humidity for a minimum of 4 hours to ensure they reach equilibrium with the atmosphere.
Method for determination of Breathability (differential pressure)
- The sample holder is sealed and the differential manometer is calibrated to zero. The pump is started and the airflow rate is adjusted to 8 liters per minute (l/min).
- The test specimen is placed across the 25 mm diameter orifice. The specimen is clamped in place using a mechanical clamp with sufficient pressure to prevent any air leaks.
- It is important to ensure that the airflow rate remains at 8 l/min after placing the specimen. If the flow rate deviates, leaks must be checked and the clamping pressure should be adjusted.
- The differential pressure is measured using a differential pressure manometer.
Splash resistance (synthetic blood) Test
Splash resistance testing assesses how well medical face masks can resist penetration by synthetic blood. This test is important to ensure the mask can effectively protect the wearer from exposure to fluids.
Note – ISO 22609: 2004 outlines a test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood.
When tested in accordance with ISO 22609, EN 14683 recommends that fluid resistance be tested with synthetic blood at pressures 120mm Hg (≥ 16.0).
Mask microbial cleanliness (Bioburden) Test
The microbial cleanliness test measures the microbial contamination on a face mask.
Note – ISO 11737-1-2018 specifies requirements and efficacy criteria for sterility testing of products, components and raw materials intended for use in the medical area. When tested according to EN ISO 11737-1:2018, the bioburden of the medical mask should be ≤ 30 CFU/g.
Method for mask microbial cleanliness (Bioburden)
Sample preparation
- The test specimen mask is aseptically removed from its packaging.
- The mask is placed in a 500 ml sterile bottle containing 300 ml of extraction liquid.
- The bottle is placed on an orbital shaker and shaken for 5 minutes at 250 rpm.
Filtration and plating
- After the extraction step, 100 ml of the extraction liquid is filtered through a 0.45 μm filter.
- The filtrate is spread onto Tryptone Soy Agar (TSA) plates to determine the total viable aerobic microbial count.
- Another 100 ml aliquot of the extraction liquid is filtered and the filtrate is plated on Sabouraud Dextrose Agar (SDA) with chloramphenicol to enumerate fungal growth.
Incubation
- The inoculated TSA plates are incubated at 30 °C for 3 days.
- The SDA plates are incubated at (20 to 25) °C for 7 days.
Enumeration
- The number of colonies on TSA and SDA plates is counted to determine the total bioburden of the mask.
Biocompatibility test
Biocompatibility test for medical face masks is performed to determine cytotoxic, allergic or sensitizing reactions of mask materials on the user’s skin.
Note – The biocompatibility of face masks should be analyzed according to ISO 10993-1:2009.
Performance requirements for medical masks
Test | Type I | Type II | Type IIR |
Bacterial filtration efficiency (BFE), (%) | ≥ 95 | ≥ 98 | ≥ 98 |
Differential pressure (Pa/cm2) | < 40 | < 40 | < 60 |
Splash resistance pressure (kPa) | Not required | Not required | ≥ 16,0 |
Microbial cleanliness (cfu/g) | ≤ 30 | ≤ 30 | ≤ 30 |
Importance of EN 14683 Test
EN 14683 testing is essential for healthcare professionals and manufacturers because it ensures the quality and effectiveness of medical face masks. Face masks play an important role in medical settings, especially during surgeries or similar situations, where there’s a known risk of infection transmission through droplets and aerosols.
Face masks act as a preventive measure to reduce the risk of spreading infections through coughing, sneezing and talking. Manufacturers of medical face masks must submit efficacy data reports to regulatory authorities to demonstrate that their products meet safety and performance standards.
Benefits of performing the test
- Regulatory compliance: Helps manufacturers meet strict regulations thus making it easier to gain market approval and acceptance for their products.
- Quality assurance: Ensures masks meet high-quality standards thus effectively blocking contaminated droplets and pollutants.
- Consumer confidence: Builds trust among users by showing that the masks have been rigorously tested and meet safety standards.
- Epidemic and pandemic preparedness: Ensures masks provide essential protection in high-risk environments during health crises.
Need Assistance with EN 14683 Testing for Your Medical Masks? MIS Is Here to Help!
As a leading global microbiology testing lab, MIS specializes in providing comprehensive medical mask testing services. Our team of proficient professionals excels in devising and implementing test protocols that align with industry standards and regulations.
In addition to EN 14683, we also provide other standard tests such as ISO 22609 to evaluate the splash resistance of medical face masks.
To obtain a quote on EN 14683 or for more information regarding our microbiology testing services, please contact our team of experts at your earliest convenience.
FAQs
BS EN 14683 standard assesses the quality and performance of medical face masks by providing the standard requirements for testing bacterial filtration efficiency, breathability, splash resistance and microbial cleanliness.
The test is applicable to evaluate the suitability of medical face masks for use in operating rooms and healthcare settings with similar requirements.
The test takes 3-4 weeks to complete.
At Microbe Investigations Switzerland, we perform this test using Staphylococcus aureus (ATCC 6538P). Additional strains can be added on customer request.
Testing ensures the safety and effectiveness of face masks by specifying performance requirements and test methods for bacterial filtration efficiency (BFE), breathability (differential pressure), splash resistance and microbial cleanliness (bioburden).
Medical face masks are classified into three types – Type I (for use by patients and other individuals), Type II (for use by healthcare professionals) and Type II R (splash resistance).
Yes, it can be modified to test various face mask materials.
The key performance criteria measured in this test include Bacterial Filtration Efficiency (≥ 95% for Type I and ≥ 98% for Type II and Type II R), differential pressure (< 40 Pa/cm2 for Type I and II and < 60 Pa/cm2 for Type II R), splash resistance (≥ 16,0 kPa for Type II R) and microbial cleanliness (≤ 30 cfu/g for all masks).
BFE is tested by clamping a mask specimen between a six-stage cascade impactor and an aerosol chamber. An aerosol of Staphylococcus aureus is introduced into the chamber and drawn through the mask under vacuum. The impactor collects any bacteria passing through the mask and the BFE is calculated as the percentage of bacteria filtered out compared to the challenge aerosol.
Microbial cleanliness (bioburden) measures the level of microbial contamination on a mask. This is done by isolating microorganisms from the mask and counting the colony-forming units (CFUs) per gram. A bioburden of ≤ 30 CFU/g is the passing criterion.
Differential pressure (breathability) indicates how easily the wearer can breathe while wearing the mask.
Splash resistance is evaluated by testing the mask with synthetic blood at a specified pressure (120 mm Hg). The mask must resist penetration by the synthetic blood to pass the test.
Benefits of testing include compliance with international standards, reliable and accurate test results, enhanced marketability and acceptance of the product.
Non-compliance might result in regulatory penalties and restrictions, the loss of market access and product recalls and increased infection risk due to insufficient protection.
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