EN 14683:2019

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 evropski standard določa zahteve glede izdelave, zasnove 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

• Status: Withdrawn
• Publication Date: 26-Mar-2019
• Withdrawal Date: 13-Apr-2025
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-Aug-2019
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 14683:2019 - Medical face masks - Requirements and test methods

Relations

• Replaces: EN 14683:2014 - Medical face masks - Requirements and test methods
• Effective Date: 09-Sep-2015
• Merged Into: EN 14683:2019+AC:2019 - Medical face masks - Requirements and test methods
• Effective Date: 16-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske maske za obraz - Zahteve in preskusne metodeMedizinische Gesichtsmasken - Anforderungen und PrüfverfahrenMasques à usage médical - Exigences et méthodes d'essaiMedical face masks - Requirements and test methods11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 14683:2019SIST EN 14683:2019en,fr,de01-maj-2019SIST EN 14683:2019SLOVENSKI
STANDARDSIST EN 14683:20141DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14683
March
t r s { ICS
s sä s v r Supersedes EN
s v x z uã t r s vEnglish Version
Medical face masks æ Requirements and test methods Masques à usage médical æ Exigences et méthodes d 5essai
Medizinische Gesichtsmasken æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on
s { November
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
t r s { CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s v x z uã t r s { ESIST EN 14683:2019

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 ± 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 SIST EN 14683:2019

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
IEC Electropedia: available at http://www.electropedia.org/
ISO Online browsing platform: available at http://www.iso.org/obp 3.1 aerosol gaseous suspension of solid and/or liquid particles 3.2 bacterial filtration efficiency BFE efficiency of the medical face mask material(s) as a barrier to bacterial penetration Note 1 to entry: The BFE test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials. 3.3 biocompatibility quality of being accepted in a specific living environment without adverse or unwanted side effects SIST EN 14683:2019

¶ 30 CFU/g tested (see Table 1). NOTE EN ISO 11737-1:2018 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package. To determine the mask’s bioburden according to EN ISO 11737-1:2018, refer to the procedure as described in Annex D. The number of masks that shall be tested is minimum 5 of the same batch/lot. Other test conditions as described in EN ISO 11737-1:2018 may be applied. In the test report, indicate the total bioburden per individual mask and based on the mask weight, the total bioburden per gram. 5.2.6 Biocompatibility According to the definition and classification in EN ISO 10993-1:2009, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993-1:2009 and determine the applicable toxicology testing regime. The results of testing should be documented according to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request. 5.2.7 Summary of performance requirements Table 1 — Performance requirements for medical face masks Test Type I a
Type II Type IIR Bacterial filtration efficiency (BFE), (%)
· 95
· 98
· 98 Differential pressure (Pa/cm2) < 40 < 40 < 60 Splash resistance pressure (kPa) Not required Not required
· 16,0 Microbial cleanliness (cfu/g)
¶ 30
¶ 30
¶ 30 a Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements. 6 Marking, labelli
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