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

Status
Published
Publication Date
02-Sep-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Aug-2019
Due Date
24-Oct-2019
Completion Date
03-Sep-2019

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SLOVENSKI STANDARD
SIST EN 14683:2019+AC:2019
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
SIST EN 14683:2019+AC:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 14683:2019+AC:2019
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SIST EN 14683:2019+AC:2019
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.
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SIST EN 14683:2019+AC:2019
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

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SIST EN 14683:2019+AC:2019
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

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SIST EN 14683:2019+AC:2019
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 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.
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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
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.

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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
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

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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
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
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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
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.

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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
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
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)
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 Directive (93/42/EEC) or Annex I, §23, of the Medical Device

Regulation (EU) 2017/745 specifies the information that should be specified on the packaging in which

the medical face mask is supplied.
The following information shall be supplied:
a) number of this European Standard;
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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
b) type of mask (as indicated in Table 1).
EN ISO 15223-1:2016 and EN 1041:2008+A1:2013 should be considered.
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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
Annex A
(informative)
Information for users

When breathing, speaking, coughing, sneezing, etc., one releases smaller or larger amounts of droplets

of secretions from the mucous membranes in the mouth and nose. The majority of the nuclei are

between 0,5 μm and 12 μm in diameter and especially the larger droplets can contain microorganisms

from the source site. Nuclei can subsequently spread through the air to a susceptible site such as an

open operating wound or sterile equipment.

The medical face masks intended to be used in operating rooms and health care settings with similar

requirements are designed to protect the entire working environment. This standard describes two

types of medical face masks with associated protection levels. As a minimum, Type I medical face masks

are used for patients in order to reduce the risk of the spread of infections, particularly in epidemic or

pandemic situations. Type II masks are principally intended for use by healthcare professionals in an

operating room or other medical settings with similar requirements.

A special case, also covered by the European Medical Devices legislation, is that in which the wearer

wishes to protect him/herself against splashes of potentially contaminated fluids.

If the intended use of the mask is to protect the wearer against infective agents (bacteria, viruses or

fungi), the use of a respirator device is applicable in accordance with the Personal Protective Equipment

(PPE) Directive (89/686/EEC) or the Personal Protective Equipment (PPE) Regulation (EU) 2016/425.

Performance requirements for respirators are the scope of EN 149.

The level of efficiency offered by a mask depends on a number of factors such as the filtration efficiency,

quality of the material and the fit of the mask on the wearer’s face. Different designs are suited for

different applications and the careful choice of mask is therefore important in order to achieve the

desired result.

The filtration capacity of mask materials can vary depending on the filter media. The fit of masks varies

considerably from those which are held in place by ear loops fastened behind the wearer’s ears to those

with tie bands around the head and a nose clamp that can be shaped to the wearer’s nose.

It is usual to characterize mask performance using in vitro tests of the material from which the mask is

made. It is, however, important to consider the fit of the mask carefully when a mask for a certain

application is chosen.

A further factor to be considered is the capacity of the mask to absorb moisture from the exhaled air

and thereby to maintain its performance over a longer period of time. The more advanced designs

easily maintain their performance throughout even very long operations whereas the less advanced

ones are intended only for short procedures.

Due to the fact that used masks are considered highly contaminated, it is essential that:

— the body of the mask is not touched by the fingers/hands of the wearer;
— hands are disinfected (full hand disinfection) after mask removal;

— a mask is worn covering the nose and mouth of the wearer, at no time a mask is hanging around the

neck of the wearer;

— a used mask should be disposed of when no longer needed or between two procedures; when there

is a further need for protection a new mask should be put on.
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SIST EN 14683:2019+AC:2019
EN 14683:2019+AC:2019 (E)
Annex B
(normative)
Method for in vitro determination of bacterial filtration efficiency (BFE)
B.1 General

WARNING — Staphylococcus aureus is a pathogen. The relevant national provisions by law and hygienic

instructions when dealing with pathogens shall be complied with.
B.2 Principle

A specimen of the mask material is clamped between a six-stage cascade impactor and an aerosol

chamber. An aerosol of Staphylococcus aureus is introduced into the aerosol chamber and drawn

through the mask material and the impactor under vacuum. The bacterial filt
...

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