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

Status
Not Published
Publication Date
02-Feb-2025
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
23-Nov-2023
Due Date
10-Mar-2023
Completion Date
23-Nov-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 14683:2023
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
oSIST prEN 14683:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 14683:2023

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oSIST prEN 14683:2023


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.

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oSIST prEN 14683:2023
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) .
...

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