EN 14683:2019+AC:2019

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, Norway, Poland, Portugal, Republic of
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
The transmission of infective agents during surgical procedures in operating theatres and other medical
settings can occur in several ways. Sources are, for example, the noses and mouths of members of the
surgical team. The main intended use of medical face masks is to protect the patient from infective
agents and, additionally, in certain circumstances to protect the wearer against splashes of potentially
contaminated liquids. Medical face masks may also be intended to be worn by patients and other
persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations.
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a
risk management process (ISO 10993-1:2009)
EN ISO 11737-1:2018, Sterilization of health care products — Microbiological methods — Part 1:
Determination of a population of microorganisms on products (ISO 11737-1:2018)
ISO 22609:2004, Clothing for protection against infectious agents — Medical face masks — Test method
for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• 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
3.4
cleanliness
freedom from unwanted foreign matter
Note 1 to entry: Such matter can be microorganisms, organic residues or particulate matter.
3.4.1
microbial cleanliness
freedom from population of viable micro-organisms on a product and/or a package
Note 1 to entry: In practical use, microbial cleanliness is often referred to as “bioburden”.
3.5
colony forming unit
CFU
unit by which the culturable number of microorganisms is expressed
Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to
form colonies on a solid nutrient medium.
3.6
differential pressure
air permeability of the mask, measured by determining the difference of pressure across the mask
under specific conditions of air flow, temperature and humidity
Note 1 to entry: The differential pressure is an indicator of the “breathability” of the mask.
3.7
filter
material used for mechanical and physical separation or deposition of aerosol particles (liquid or solid)
from the inhaled and exhaled air
3.8
infective agent
microorganism that has been shown to cause surgical wound infections or that might cause infection in
the patient, members of staff or other
3.9
medical face mask
medical device covering the mouth and nose providing a barrier to minimize the direct transmission of
infective agents between staff and patient
Note 1 to entry: Transmission of fluid-borne agents from patients to staff may occur via splashes.
3.10
splash resistance
ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure
3.11
surgical procedure
surgical intervention penetrating by skin or mucosa, performed by a surgical team under controlled
environmental conditions
4 Classification
Medical face masks specified in this European Standard are classified into two types (Type I and
Type II) according to bacterial filtration efficiency whereby Type II is further divided according to
whether or not the mask is splash resistant. The 'R' signifies splash resistance.
5 Requirements
5.1 General
5.1.1 Materials and construction
The medical face mask is a medical device, generally composed of a filter layer that is placed, bonded or
moulded between layers of fabric. The medical face mask shall not disintegrate, split or tear during
intended use. In the selection of the filter and layer materials, attention shall be paid to cleanliness.
5.1.2 Design
The medical face mask shall have a means by which it can be fitted closely over the nose, mouth and
chin of the wearer and which ensures that the mask fits closely at the sides.
Medical face masks may have different shapes and constructions as well as additional features such as a
face shield (to protect the wearer against splashes and droplets) with or without anti-fog function, or a
nose bridge (to enhance fit by conforming to the nose contours).
5.2 Performance requirements
5.2.1 General
All tests shall be carried out on finished products or samples cut from finished products.
5.2.2 Bacterial filtration efficiency (BFE)
When tested in accordance with Annex B, the BFE of the medical face mask shall conform to the
minimum value given for the relevant type in Table 1.
For thick and rigid masks such as rigid duckbill or cup masks the test method may not be suitable as a
proper seal cannot be maintained in the cascade impactor. In these cases, another valid equivalent
method shall be used to determine the BFE.
When a mask consists of two or more areas with different characteristics or different layer-
composition, each panel or area shall be tested individually. The lowest performing panel or area shall
determine the BFE value of the complete mask.
5.2.3 Breathability
When tested in accordance with Annex C, the differential pressure of the medical face mask shall
conform to the value given for the relevant type in Table 1.
If the use of a respiratory protective device as face mask is required in an operating theatre and/or
other medical settings, it might not fulfil the performance requirements with regard to differential
pressure as defined in this European Standard. In such case, the device should fulfil the requirement as
specified in the relevant Personal Protective Equipment (PPE) standard(s).
5.2.4 Splash resistance
When tested in accordance with ISO 22609:2004 the resistance of the medical face mask to penetration
of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1.
5.2.5 Microbial cleanliness (Bioburden)
When tested according to EN ISO 11737-1:2018 the bioburden of the medical mask shall be ≤ 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
a
Test Type I Type II Type IIR
Bacterial filtration
≥ 95 ≥ 98 ≥ 98
efficiency (BFE), (%)
Differential pressure
< 40 < 40 < 60
(Pa/cm )
Splash resistance
Not required Not required ≥ 16,0
pressure (kPa)
Microbial cleanliness
≤ 30 ≤ 30 ≤ 30
(cfu/g)
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, labelling and packaging
Annex I, §13, of the Medical Devices Directiv
...