BS EN 14683:2019 — Medical Face Masks: Requirements and Test Methods
BS EN 14683:2019 specifies the requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements.
A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
What BS EN 14683:2019 Covers
Bacterial Filtration Efficiency (BFE)
Annex B In Vitro Method
Annex B of the standard specifies the method for in vitro determination of BFE of medical face mask materials — the core performance test for mask classification.
Viral Filtration Efficiency (VFE)
Airmid Adapted Method
As no established standard currently exists for VFE, Airmid has adapted the Annex B BFE method for virus testing — enabling manufacturers to generate comparable viral filtration data alongside their BFE results.
How the BS EN 14683:2019 Test Works
- Preparation: Face mask materials are prepared and conditioned in accordance with the standard’s construction and design requirements.
- Aerosol Challenge: A defined aerosol of bacterial or viral challenge organism is generated and directed at the mask material under controlled flow conditions.
- Downstream Capture: Particles that penetrate the mask are captured on a sampling medium downstream and enumerated.
- Efficiency Calculation: Filtration efficiency is calculated by comparing the upstream challenge concentration to downstream penetration — expressed as a percentage.
- Classification: Results are assessed against the performance thresholds defined in BS EN 14683:2019 for Type I, Type II, and Type IIR mask classifications.
Mask Classifications Under BS EN 14683:2019
Type I
Minimum BFE of 95%. Intended for patients and members of the public to reduce the risk of spreading infection.
Type II
Minimum BFE of 98%. Designed for use by healthcare personnel in clinical settings.
Type IIR
Minimum BFE of 98% plus splash resistance. Suitable for surgical procedures where fluid exposure is a risk.
Key Parameters
Turnaround Time
4 Weeks
From receipt of samples
Primary Tests
BFE & VFE
Bacterial and viral filtration efficiency
Third-Party Validation
On passing this test, the product can be labelled as tested by Airmid Healthgroup to BS EN 14683:2019 — in support of any claim relating to the test and data received. Independent third-party certification strengthens consumer and regulatory confidence in your product’s filtration performance.
Request a Quote for BS EN 14683:2019 Testing
Contact Airmid Healthgroup to discuss your medical face mask testing requirements and receive a tailored quote for BFE and/or VFE testing.
Frequently Asked Questions
What is the difference between BFE and VFE testing?
Bacterial filtration efficiency (BFE) is the established in vitro method defined in Annex B of BS EN 14683:2019, using a bacterial aerosol challenge to quantify how effectively a mask material filters microorganisms. Viral filtration efficiency (VFE) uses the same principle but with a viral challenge organism. Because no formal standard for VFE currently exists, Airmid has adapted the Annex B method for virus testing — allowing manufacturers to generate credible, comparable viral filtration data alongside their BFE results.
What mask types and classifications does BS EN 14683:2019 define?
The standard defines three mask types. Type I must achieve a minimum BFE of 95% and is intended for patients and the public. Type II must achieve a minimum BFE of 98% and is designed for healthcare personnel. Type IIR meets the same 98% BFE threshold but additionally passes a splash resistance test — making it suitable for surgical procedures where fluid exposure is a risk.
Can the test be applied to non-medical face coverings or novel mask materials?
The standard is specifically written for medical face masks, but the Annex B test method can be applied to other face covering materials where a manufacturer wishes to quantify filtration performance using a recognised methodology. If your product sits outside the strict medical device classification, our team can advise on whether BS EN 14683:2019 is the most appropriate framework or whether an alternative test method would better support your claims.
How much sample material do I need to submit?
The quantity required depends on whether you are submitting finished masks or flat material for testing, and whether you require both BFE and VFE. As a general guide, sufficient material for a minimum of three replicate test runs per method is required. Our team will confirm exact sample requirements when you submit your enquiry.
What documentation will I receive on completion of testing?
You will receive a full GLP test report detailing the test methodology, challenge conditions, replicate results, calculated filtration efficiency values, and a pass or fail conclusion against the relevant BS EN 14683:2019 performance thresholds. Products that pass are eligible to carry the Airmid Healthgroup certification label. If both BFE and VFE testing are conducted, a combined report covering both methods can be provided.
Related Tests and Services
- BS EN ISO 20743:2021 — Antibacterial Activity of Textiles
- Microbial Strikethrough — Bacteria Penetration Test
- ISO 18184:2019 — Antiviral Testing for Textiles
- ISO 13629-2:2014 — Antiviral Activity of Textile Products
- BS EN 1276 — Bactericidal Activity
- BS EN 1275 — Fungicidal / Yeasticidal Activity
- BS EN 1040 — Basic Bactericidal Activity
- BS EN 13727 — Bactericidal Activity in the Medical Area
- BS EN 13704 — Sporicidal Activity
- BS EN 13610 — Virucidal Activity
