FprEN 14683
(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. Compliance with this standard does not demonstrate compliance with the requirements of the relevant PPE regulations.
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. Die Einhaltung dieser Norm bedeutet nicht die Erfüllung der Anforderungen der maßgeblichen Vorschriften für PSA.
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. La conformité à la présente norme ne prouve pas la conformité aux exigences énoncées dans les réglementations pertinentes en matière d’EPI.
Medicinske maske za obraz - Zahteve in preskusne metode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2023
Nadomešča:
SIST EN 13795-2:2019
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: prEN 14683
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 14683
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2023
ICS 11.140 Will supersede 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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14683:2023 E
worldwide for CEN national Members.
prEN 14683:2023 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Classification. 8
5 Requirements . 8
5.1 General. 8
5.1.1 Materials and construction . 8
5.1.2 Design . 8
5.2 Performance requirements . 9
5.2.1 General. 9
5.2.2 Bacterial filtration efficiency (BFE) . 9
5.2.3 Breathability . 9
5.2.4 Splash resistance . 9
5.2.5 Microbial cleanliness (Bioburden) . 9
5.2.6 Biocompatibility . 10
5.2.7 Summary of performance requirements . 10
6 Manufacturing and processing requirements and documentation . 11
7 Marking, labelling and packaging . 11
Annex A (informative) Information for users . 12
A.1 Selection and use . 12
A.2 Donning and doffing. 12
Annex B (normative) Method for in vitro determination of bacterial filtration efficiency
(BFE) . 13
B.1 General. 13
B.2 Principle . 13
B.3 Reagents and materials . 13
B.3.1 General. 13
B.3.2 Tryptic soy agar . 13
B.3.3 Tryptic soy broth . 13
B.3.4 Peptone water . 14
B.3.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants. . 14
B.4 Test apparatus . 14
B.5 Test specimens . 14
B.6 Preparation of bacterial challenge . 15
B.7 Procedure . 15
B.8 Calculation of bacterial filtration efficiency (BFE) . 17
prEN 14683:2023 (E)
B.9 Test report . 17
Annex C (normative) Breathability – Method for determination of the differential pressure
................................................................................................................................................................... 19
C.1 Principle . 19
C.2 Test apparatus . 19
C.3 Test specimens . 20
C.4 Procedure . 20
C.5 Calculation of differential pressure . 21
C.6 Test report . 21
Annex D (informative) Test procedure for microbial cleanliness . 23
Annex E (informative) Rationales . 24
E.1 General . 24
E.2 Sizing of medical face masks. 24
E.3 Leakage around the medical face mask . 24
E.4 Shelf life determination . 24
E.5 Why does the document only test the filter using bacteria rather than viruses? . 24
E.6 Breathability as determined by the differential pressure . 25
E.7 Where did the limits in this document come from? . 25
E.8 Bypass leakage. 25
E.9 Design . 26
Annex F (informative) Transparent medical face masks . 27
F.1 General . 27
F.2 Breathability . 27
F.3 Differential pressure measurement of TMFM . 27
F.4 Particle attenuation . 28
F.5 Filtration measurement of TMFM . 28
F.6 Fit . 28
F.7 Function . 28
F.8 Condensation . 28
F.9 Acoustics . 28
F.10 Durability . 29
F.11 References . 29
Annex G (informative) Environmental impact . 30
Annex ZA (informative) Relationship between this European Standard and General Safety
and Performance Requirements of Regulation (EU) 2017/745 [OJ L 117] aimed to be
covered . 32
Bibliography . 34
prEN 14683:2023 (E)
European foreword
This document (prEN 14683:2023) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14683:2019+AC:2019.
prEN 14683:2023 includes the following significant technical changes with respect to
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 (biob
...
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