EN 14683:2019+AC:2019
(Main + Amendment)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 European Standard is not applicable to masks intended exclusively for the personal protection of staff.
NOTE 1 Standards for masks for use as respiratory personal protective equipment are available.
NOTE 2 Annex A provides information for the users of medical face masks.
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 ebenso hinsichtlich der Verringerung von Absonderungen infektiöser Keime aus Mund und Nase eines asymptomatischen Trägers oder eines Patienten mit klinischen Symptomen wirksam sein.
Diese Europäische Norm gilt nicht für Masken, die ausschließlich für den persönlichen Schutz des Personals bestimmt sind.
ANMERKUNG 1 Normen für Masken zum Gebrauch als persönliche Atemschutzausrüstung stehen zur Verfügung.
ANMERKUNG 2 Anhang A stellt Informationen für die Benutzer medizinischer Gesichtsmasken zur Verfügung.
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.
La présente Norme européenne ne s’applique pas aux masques exclusivement destinés à la protection individuelle des membres de l’équipe.
NOTE 1 Il existe des normes relatives aux masques destinés à la protection individuelle des voies respiratoires.
NOTE 2 L’Annexe A apporte des informations aux utilisateurs des masques à usage médical.
Medicinske maske za obraz - Zahteve in preskusne metode
Ta dokument določa zahteve glede izdelave, načrtovanja in učinkovitosti ter preskusne metode za medicinske maske za obraz, ki so namenjene omejevanju prenosa povzročiteljev infekcije z zaposlenih na bolnike med kirurškimi postopki in v drugih zdravstvenih okoljih s podobnimi zahtevami. Medicinska maska za obraz z ustrezno mikrobno pregrado je lahko učinkovita pri zmanjševanju razširjanja povzročiteljev infekcije iz nosa in ust asimptomatskega prenašalca ali bolnika s kliničnimi znaki.
Ta evropski standard se ne uporablja za maske, ki so namenjene izključno osebni zaščiti zaposlenih.
OPOMBA 1: Na voljo so standardi za maske, ki se uporabljajo za osebno varovalno opremo.
OPOMBA 2: V dodatku A so podane informacije za uporabnike medicinskih mask za obraz.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2019
Nadomešča:
SIST EN 14683:2019
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 14683:2019+AC:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 14683:2019+AC
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2019
EUROPÄISCHE NORM
ICS 11.140
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 19 November 2018 and includes Corrigendum AC approved by CEN on 19
November 2018.
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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14683:2019+AC:2019 E
worldwide for CEN national Members.
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 . 8
5.2.1 General . 8
5.2.2 Bacterial filtration efficiency (BFE) . 8
5.2.3 Breathability . 8
5.2.4 Splash resistance . 8
5.2.5 Microbial cleanliness (Bioburden) . 9
5.2.6 Biocompatibility . 9
5.2.7 Summary of performance requirements . 9
6 Marking, labelling and packaging . 9
Annex A (informative) Information for users . 11
Annex B (normative) Method for in vitro determination of bacterial filtration efficiency
(BFE) . 12
B.1 General . 12
B.2 Principle . 12
B.3 Reagents and materials . 12
B.3.1 General . 12
B.3.2 Tryptic soy agar . 12
B.3.3 Tryptic soy broth . 12
B.3.4 Peptone water . 13
B.3.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants. . 13
B.4 Test apparatus. 13
B.4.1 Six stage cascade impactor, the arrangement is specified in Table B.1. . 13
B.4.2 Nebulizer, capable of delivering particles with a mean size of (3,0 ± 0,3) μm when in
contact with the cascade impactor. . 13
B.4.3 Aerosol chamber, glass, 600 mm long and 80 mm in external diameter. . 13
B.4.4 Flow meters, capable of measuring a flow rate of 28,3 l/min. . 13
B.4.5 Pressure gauge, capable of measuring a pressure of 35 kPa to an accuracy of ± 1 kPa. . 13
B.4.6 Erlenmeyer flasks, 250 ml and 500 ml capacity. . 13
B.4.7 Peristaltic or syringe pump, capable of delivering 0,01 ml/min. 13
B.4.8 Vacuum pump, capable of maintaining a flow rate of 57 l/min. . 13
B.5 Test specimens . 13
B.6 Preparation of bacterial challenge . 13
B.7 Procedure . 14
B.8 Calculation of bacterial filtration efficiency (BFE) . 15
B.9 Test report . 16
Annex C (normative) Method for determination of breathability (differential pressure) . 18
C.1 Principle . 18
C.2 Test apparatus . 19
C.2.1 Mass flow meter(s) capable of measuring an airflow of 8 l/min. . 19
C.2.2 Manometer, a differential manometer (water or digital). Individual manometers can
also be used. M1 is for the upstream pressure measurement and M2 is for the
downstream pressure measurement. . 19
C.2.3 Electric vacuum pump including a pressure buffer tank. . 19
C.2.4 Valve permitting the adjustment of the flow rate. . 19
C.2.5 Sample holder . 19
C.3 Test specimens . 19
C.4 Procedure . 20
C.5 Calculation of differential pressure . 20
C.6 Test report . 20
Annex D (informative) Microbial cleanliness . 21
D.1 Sampling . 21
D.2 Testing . 21
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered . 22
Bibliography . 23
European foreword
This document (EN 14683:2019+AC:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
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 includes Corrigendum 1 issued by CEN on 7 August 2019.
This document supersedes ˜EN 14683:2019™.
This document includes the corrigendum 1 which updates a requirement in clause B.7.4.
The start and finish of text introduced or altered by corrigendum is indicated in the text by tags ˜™.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The main changes compared to the previous edition are:
a) the appropriate method for in vitro determination of bacterial filtration efficiency (BFE) provided
in Annex B has been updated;
b) the former deleted note in 5.2.3 on the breathability requirements has been reintroduced as
standard text; it provides a recommendation regarding the use of a respiratory protective device;
c) the performance requirements on the breathability (differential pressure) provided in Table 1 have
been increased and the appropriate method for determination provided in Annex C has been
completely reviewed;
d) the determination of the microbial cleanliness (bioburden) has been slightly updated and moved
from 5.2.5 to a new informative Annex D.
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, No
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