What is BS EN 14683:2025 - Medical face masks requirements and test methods about?
A revised European standard, BS EN 14683:2025 sets out how to design and test face masks that limit the transmission of infections. The revisions include an updated test for microbial cleanliness and new requirements for transparent masks.
Who is BS EN 14683:2025 - Medical face masks requirements and test methods for?
This standard should be used by:
• medical device testing laboratories;
• manufacturers of medical, surgical, ophthalmic, and veterinary instruments and apparatus;
• NHS procurement professionals;
• developers and providers of personal protection and disposable safety/healthcare products; and
• companies providing commercial, physical, and biological research and development.
What does BS EN 14683:2025 - Medical face masks requirements and test methods cover?
BS EN 14683:2025 specifies the construction, design, performance 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.
NOTE: This standard is not applicable to masks intended exclusively for the personal protection of staff.
Why should you use BS EN 14683:2025 - Medical face masks requirements and test methods?
This standard:
• Supports compliance: BS EN 14683:2025 aligns with and can help manufacturers demonstrate presumption of conformity with the Medical Device Regulation (EU) 2017/745.
• Instils confidence: It provides assurance that compliant face masks offer an optimal level of protection.
• Provides clarity: It standardizes and clarifies some areas that were open to interpretation in the previous edition.
• Ensures sustainability: It formalizes the status of reusable medical face masks and includes new considerations on the environmental impact of face mask manufacture and processing.
• Considers bioburden: It gives more detailed requirements on microbial cleanliness and an improved test procedure.
• Supports inclusion: It gives guidance on transparent masks to help remove barriers for people with cognitive impairments and meet new market demands.
• Facilitates procurement: It provides a solid foundation for use in contracts and tenders.
• Provides a blueprint for innovation: It helps product designers to develop future face masks that will be effective at reducing the risk of the spread of infections.
What has changed?
BS EN 14683:2025 supersedes BS EN 14683:2019, in comparison with which the following technical modifications have been made:
a) the terms “processor”, “reusable product”, “single-use product” and “transparent medical face mask” have been added to Clause 3 Terms and definitions;
b) Clause 5.1.2 Design has been amended, first to clarify that requirements for additional features to medical face masks are not specified in this document and secondly to include transparent medical face masks;
c) the requirements on microbial cleanliness (bioburden) have been specified in more detail;
d) the unit of differential pressure has been changed to Pa;
e) a new Clause 6 Manufacturing and processing requirements and documentation has been added;
f) the Annex A Information for users has been completely revised;
g) Annex B Method for in vitro determination of bacterial filtration efficiency (BFE) has been further specified in regard to the use of the six-stage cascade impactor;
h) Annex C Breathability – Method for determination of the differential pressure has been completed with a formula for the calculation of the airflow, when a different test area is used than the circular test area of 25 mm in diameter;
i) the option to use Acceptance Quality Limits (AQLs) for sample numbers in Annex B and Annex C has been removed;
j) Annex D Test procedure for microbial cleanliness has been completely revised;
k) a new informative Annex E Rationales has been added to provide a concise rationale for the important requirements of this document. It includes information on the proposed removal of Type I products in the next revision;
l) a new informative Annex F Transparent medical face masks has been added;
m) a new informative Annex G Environmental impact has been added;
n) aligns to Medical Device Regulation (EU) 2017/745 (including updated Annex ZA);
o) updates normative references and bibliography.
