SIST EN 14683:2025
(Main)Medical face masks - Requirements and test methods
Medical face masks - Requirements and test methods
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.
Medizinische Gesichtsmasken - Anforderungen und Prüfverfahren
Dieses Dokument legt Aufbau und Gestaltung, Leistungsanforderungen sowie Prüfverfahren für medizinische Gesichtsmasken fest, die dazu dienen, die Übertragung infektiöser Keime vom Personal auf Patienten während chirurgischer Eingriffe und sonstiger medizinischer Situationen mit ähnlichen Anforderungen zu begrenzen. Eine medizinische Gesichtsmaske mit einer geeigneten mikrobiologischen Barriere kann darüber hinaus hinsichtlich der Verringerung von Absonderungen infektiöser Keime aus Mund und Nase eines asymptomatischen Trägers oder eines Patienten mit klinischen Symptomen wirksam sein.
Dieses Dokument gilt nicht für Gesichtsmasken, die ausschließlich für den persönlichen Schutz des Personals bestimmt sind.
Masques à usage médical - Exigences et méthodes d'essai
Le présent document spécifie les exigences de fabrication, de conception et de performance, ainsi que les méthodes d’essai relatives aux masques à usage médical destinés à limiter la transmission d’agents infectieux des membres de l’équipe médicale aux patients lors d’actes chirurgicaux et d’autres actes médicaux aux exigences similaires. Un masque à usage médical présentant une barrière antimicrobienne appropriée peut également s’avérer efficace pour diminuer l’émission d’agents infectieux venant du nez et de la bouche d’un patient présentant des symptômes cliniques ou asymptomatique.
Le présent document ne s’applique pas aux masques exclusivement destinés à la protection individuelle des membres de l’équipe médicale.
Medicinske maske za obraz - Zahteve in preskusne metode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 14683:2019+AC:2019
Medicinske maske za obraz - Zahteve in preskusne metode
Medical face masks - Requirements and test methods
Medizinische Gesichtsmasken - Anforderungen und Prüfverfahren
Masques à usage médical - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 14683:2025
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 14683
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2025
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 14683:2019+AC:2019
English Version
Medical face masks - Requirements and test methods
Masques à usage médical - Exigences et méthodes Medizinische Gesichtsmasken - Anforderungen und
d'essai Prüfverfahren
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, 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
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14683:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Classification. 9
5 Requirements . 9
5.1 General. 9
5.1.1 Materials and construction . 9
5.1.2 Design . 9
5.2 Performance requirements . 10
5.2.1 General. 10
5.2.2 Bacterial filtration efficiency (BFE) . 10
5.2.3 Breathability . 10
5.2.4 Splash resistance . 10
5.2.5 Microbial cleanliness (Bioburden) . 10
5.2.6 Biocompatibility . 11
5.2.7 Summary of performance requirements . 11
6 Manufacturing and processing requirements and documentation . 11
7 Marking, labelling and packaging . 12
Annex A (informative) Information for users . 13
A.1 Selection and use . 13
A.2 Donning and doffing. 13
Annex B (normative) Method for in vitro determination of bacterial filtration efficiency (BFE)
................................................................................................................................................................... 14
B.1 General. 14
B.2 Principle . 14
B.3 Reagents and materials . 14
B.4 Test apparatus . 15
B.5 Test specimens . 15
B.6 Preparation of bacterial challenge . 16
B.7 Procedure . 16
B.8 Calculation of bacterial filtration efficiency (BFE) . 18
B.9 Test report . 18
Annex C (normative) Breathability – Method for determination of the differential pressure
................................................................................................................................................................... 20
C.1 Principle . 20
C.2 Test apparatus . 20
C.3 Test specimens . 21
C.4 Procedure . 21
C.5 Calculation of differential pressure . 22
C.6 Test report . 23
Annex D (informative) Test procedure for microbial cleanliness . 24
Annex E (informative) Rationales . 25
E.1 General . 25
E.2 Sizing of medical face masks. 25
E.3 Leakage around the medical face mask . 25
E.4 Shelf life determination . 25
E.5 Why does the document only test the filter using bacteria rather than viruses? . 25
E.6 Breathability as determined by the differential pressure . 26
E.7 Where did the limits in this document come from? . 26
E.8 Bypass leakage. 26
E.9 Design . 27
E.10 Proposed withdrawal of Type I medical face masks . 27
E.11 Removal of AQLs in Annex B and Annex C . 28
Annex F (informative) Transparent medical face masks . 29
F.1 General . 29
F.2 Breathability . 29
F.3 Differential pressure measurement of TMFM . 29
F.4 Particle attenuation . 30
F.5 Filtration measurement of TMFM . 30
F.6 Fit . 30
F.7 Function . 30
F.8 Condensation . 30
F.9 Acoustics . 30
F.10 Durability . 31
F.11 Visibility . 31
F.12 References . 31
Annex G (informative) Environmental impact . 32
Annex ZA (informative) Relationship between this European Standard and General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
................................................................................................................................................................... 34
Bibliography . 36
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 14683:2019+AC:2019:
a) the terms “processor”, “reusable product”, “single-use product” and “transparent medical face mask”
have been added to Clause 3;
b) 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;
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 on “Manufacturing and processing requirements and documentation” has been
added;
f) Annex A “Information for users” has been completely re
...
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