SIST EN 14683:2019+AC:2019

Medical face masks - Requirements and test methods

Medicinske maske za obraz - Zahteve in preskusne metode

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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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.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.

Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 14683:2019+AC:2019 (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 . 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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 14683:2019+AC:2019 (E)
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

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 14683:2019+AC:2019 (E)
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 standar
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