National foreword

This British Standard is the UK implementation of EN 14683:2025. It supersedes BS EN 14683:2019, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/205, Non-active medical devices.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication has been prepared under a mandate given to the European Standards Organizations by the European Commission and the European Free Trade Association. It is intended to support requirements of the EU legislation detailed in the European Foreword. A European Annex, usually Annex ZA or ZZ, describes how this publication relates to that EU legislation.

For the Great Britain market (England, Scotland and Wales), if UK Government has designated this publication for conformity with UKCA marking (or similar) legislation, it may contain an additional National Annex. Where such a National Annex exists, it shows the correlation between this publication and the relevant UK legislation. If there is no National Annex of this kind, the relevant Annex ZA or ZZ in the body of the European text will indicate the relationship to UK regulation applicable in Great Britain. References to EU legislation may need to be read in accordance with the UK designation and the applicable UK law. Further information on designated standards can be found at www.bsigroup.com/standardsandregulation.

For the Northern Ireland market, UK law will continue to implement relevant EU law subject to periodic confirmation. Therefore Annex ZA/ZZ in the European text, and references to EU legislation, are still valid for this market.

UK Government is responsible for legislation. For information on legislation and policies relating to that legislation, consult the relevant pages of www.gov.uk.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2025.

This European Standard was approved by CEN on 29 December 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN 14683:2025) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2025, and conflicting national standards shall be withdrawn at the latest by July 2025.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 14683:2019+AC:2019.

EN 14683:2025 includes the following significant technical changes with respect to EN 14683:2019+AC:2019:

the terms “processor”, “reusable product”, “single-use product” and “transparent medical face mask” have been added to Clause 3;
the Clause “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;
the requirements on microbial cleanliness (bioburden) have been specified in more detail;
the unit of differential pressure has been changed to Pa;
A new Clause 6 on “Manufacturing and processing requirements and documentation” has been added;
Annex A “Information for users” has been completely revised;
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;
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 (C.4.5);
the option to use AQL for sample numbers in Annex B and Annex C has been removed;
Annex D “Test procedure for microbial cleanliness” has been completely revised;
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;
a new informative Annex F “Transparent medical face masks” has been added;
a new informative Annex G “Environmental impact” has been added;
alignment with Regulation (EU) 2017/745 (including updated Annex ZA);
update of normative references and bibliography.

This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States.

For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document.

Any feedback and questions on this document should be directed to the users’ national standards body. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Introduction

Medical face masks can be used as part of an infection control chain. The main intended use of medical face masks is to protect patients by attenuating the spread of larger particles from the wearer’s mouth and, additionally, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids. Medical face masks may also be intended to be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations.

Bypass leakage around the medical face mask can affect the particle attenuation ability of medical face masks, especially for smaller particles.

Besides the normative annexes, the following informative annexes are included:

Annex A provides information for the users of medical face masks;
Annex D provides a test procedure for microbial cleanliness;
Annex E provides a concise rationale for the important requirements of this document and is intended for use by those who are familiar with the subject of this document but who have not participated in its development;
Annex F provides some recommendations on transparent medical face masks (TMFM);
Annex G provides some information to enable the transformation to a circular economy. This included material efficiency – the conservation of materials by making products more durable, resource-efficient and which facilitates the reuse or recycling of parts and/or materials at the end of life.

Standards for face masks for use as respiratory personal protective equipment are available (e.g. EN 149:2001+A1:2009).

Technical Committee CEN/TC 205 “Non-active medical devices” proposes to remove the specification for Type I medical face masks at the next revision of this document. The reasons for doing this are documented in Annex E. Therefore, CEN/TC 205 encourages healthcare organizations and agencies to consider the potential impact on their guidance of this change.

1 Scope

This document specifies 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.

This document is not applicable to face masks intended exclusively for the personal protection of staff. Compliance with this standard does not demonstrate compliance with the requirements of the relevant PPE regulations.

2 Normative references

3 Terms and definitions

4 Classification

5 Requirements

5.1 General

5.2 Performance requirements

6 Manufacturing and processing requirements and documentation

6.1

6.2

7 Marking, labelling and packaging

Bibliography

BS EN 14683:2025

Medical face masks. Requirements and test methods

Current

Published:

31 Jan 2025