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EN 14683: 2025 Medical Face Mask Testing โ Requirements & Test Methods
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Summary
European standard EN 14683:2025 defines the performance and safety requirements for medical face masks used in healthcare settings. It evaluates bacterial filtration efficiency (BFE), breathability, splash resistance, microbial cleanliness, and biocompatibility to ensure patient and user protection.
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Quick understanding of the test
BS EN 14683:2019 - Medical Face Mask - Requirements and test methods
Mandatory test strains
- Staphylococcus aureus (ATCC 6538P)
- Standard provides various test methods to assess different properties of medical face masks.
- Ensures regulatory compliance and product safety.
Turnaround Time
Passing criteria
- BFE: โฅ 95% for Type I, โฅ 98% for Type II and Type II R.
- Differential Pressure: < 40 Pa/cmยฒ (Type I and II), < 60 Pa/cmยฒ (Type II R).
- Splash Resistance: โฅ 16.0 kPa (Type II R).
- Bioburden: โค 30 CFU/g for all mask types.
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What is EN 14683 Medical Face Mask Testing?
EN 14683 is a harmonized European standard for medical face masks under the EU Medical Device Regulation (EU) 2017/745. Masks must meet defined performance criteria based on Type I, Type II, or Type IIR classification.
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.
Scope of EN 14683 Standard
EN 14683 is applicable to medical face masks used in hospitals, clinics, and similar healthcare environments. Testing is used to ensure :
- Protection against droplets
- Filtration of bacteria
- User comfort through breathability
- Resistance to blood splashes (Type IIR)
- Biological safety of materials
EN 14683 testing excludes respirators like FFP2 or N95 masks.
Types of Medical Face Masks (Type I, II, IIR)
Type I medical face masks – Intended to be used by patients in order to minimize the risk of infection spread, particularly in epidemic or pandemic situations.
Type II medical face masks – Primarily intended to be used by healthcare professionals in
operating rooms or other similar situations/ requirements. Type II masks are subdivided into
Type II and Type 11 R according to their ability to protect the wearer against the splashes of potentially contaminated fluids. Herein, R signifies splash resistance.
EN 14683 Test Methods
The BFE test is performed to determine the resistance of the mask materials and components to bacterial penetration.
Mandatory test microorganisms: Staphylococcus aureus (ATCC 6538).
Test specimen preparation
- Five test specimens, each measuring 100 mm ร 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 ยฑ 5) ยฐC and (85 ยฑ 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 ยฐC 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.
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 โpressure dropโ) 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 ยฑ 5) ยฐC and (85 ยฑ 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 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 (โฅ 16.0).
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 โค 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 ฮผm 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 ยฐC for 3 days.
- The SDA plates are incubated at 20 to 25 ยฐC 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 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.
EN 14683 Performance Requirements Table
Test | Type I | Type II | Type IIR |
Bacterial filtration efficiency (BFE), (%) | โฅ 95 | โฅ 98 | โฅ 98 |
Differential pressure (Pa/cm2) | < 40 | < 40 | < 60 |
Splash resistance pressure (kPa) | Not required | Not required | โฅ 16,0 |
Microbial cleanliness (cfu/g) | โค 30 | โค 30 | โค 30 |
EN 14683 vs Other Standards
Aspect | EN 14683 (EU Medical Face Masks) | ASTM F2100 (US Medical Face Masks) |
Purpose | To test the quality and performance of medical face masks intended to limit transmission of infective agents in healthcare/surgical settings. | To test the performance requirements for materials used in medical face masks used in patient care and surgery. |
Face mask Classifications | Type I, Type II, Type IIR | Level 1, Level 2, Level 3 |
Results Interpretation | Defines performance criteria for Types: Type I (โฅ95% BFE) Type II/IIR (โฅ98% BFE), with ฮP and splash resistance requirements (IIR). Also includes bioburden limits. | Classifies mask material into Level 1/2/3 based on BFE (โฅ95โ98%), PFE, fluid resistance at specified mmHg, differential pressure and flammability. |
Key Difference | Focuses primarily on medical mask performance including microbial cleanliness, does not require PFE or flammability tests. Splash resistance only for Type IIR. | Includes particulate filtration (PFE) and flammability tests in addition to BFE, ฮP, and fluid resistance; defines material performance levels applicable to surgical masks. |
Regulatory relevance | Demonstrates conformity with the EU Medical Device Regulation (MDR) and supports CE marking. | Widely referenced in the United States and accepted by the FDA |
Why Choose Our Lab for EN 14683 Testing
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At Microbe Investigations Switzerland (MIS), we provide complete EN 14683 testing services to assess the performance and safety of medical face masks. Our experienced team performs tests in line with current industry standards and regulatory expectations.
If you would like a quotation or need more details about our EN 14683 testing services, reach out to our team.
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Frequently Asked Questions
DR. Martinoz Scholtz
Itโs a European standard laboratory test method to evaluate the quality and performance of medical face masks intended to limit transmission of infectious agents in medical/surgical settings.
Both Type II and IIR masks have high bacterial filtration efficiency (โฅ 98 %), but Type IIR also provides splash resistance to synthetic blood.
ฮP (differential pressure) measures the pressure difference across the mask material under controlled airflow, assessing how easily the wearer can breathe through the mask. Lower values mean better breathability.
EN 14683 is not legally mandatory for CE marking. CE marking for medical masks mainly requires compliance with the EU Medical Device Regulation (MDR). EN 14683 is a harmonized standard that helps demonstrate compliance with MDR requirements.
Bacterial Filtration Efficiency (BFE) is tested by challenging mask material with an aerosol of Staphylococcus aureus and measuring the percentage of bacteria prevented from passing through using a cascade impactor setup.
Yes, EN 14683 is specifically intended for medical/surgical masks, defining the performance tests and classifications (Type I, II, IIR) for these products.
Yes, it can be modified to test various face mask materials.
The key performance criteria measured in this test include Bacterial Filtration Efficiency (โฅ 95% for Type I and โฅ 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 (โฅ 16,0 kPa for Type II R) and microbial cleanliness (โค 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 โค 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.
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.
Face mask 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).
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