SIST EN 14683:2006
(Main)Surgical masks - Requirements and test methods
Surgical masks - Requirements and test methods
This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating theatres and other medical settings with similar requirements.
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 surgical masks.
Chirurgische Masken - Anforderungen und Prüfverfahren
Diese Europäische Norm legt die konstruktive Gestaltung von chirurgischen Masken und die Leistungsanforderungen sowie Prüfverfahren für diese fest; sie dienen dazu, die Übertragung infektiöser Keime vom Personal auf Patienten und (in bestimmten Situationen) den umgekehrten Übertragungsweg in Operationssälen und sonstigen medizinischen Einrichtungen mit ähnlichen Anforderungen zu begrenzen.
Diese 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 chirurgischer Masken zur Verfügung.
Masques chirurgicaux - Exigences et méthodes d'essai
La présente Norme européenne spécifie les exigences de construction et de performances, ainsi que les méthodes d’essai des masques chirurgicaux destinés a limiter la transmission d’agents infectieux des membres de l’équipe médicale vers les patients (et inversement dans certaines situations) lors d’actes chirurgicaux effectués dans des salles d’opération et d’autres établissements médicaux dont les exigences sont similaires.
La présente Norme européenne ne s'applique pas aux masques destinés exclusivement a la protection individuelle des membres de l’équipe médicale.
NOTE 1 Il existe des normes relatives a l’utilisation d’équipements de protection personnelle des voies respiratoires.
NOTE 2 L’Annexe A fournit des informations a destination des utilisateurs des masques chirurgicaux.
Kirurške maske – Zahteve in preskusne metode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 14683:2006
01-februar-2006
Kirurške maske – Zahteve in preskusne metode
Surgical masks - Requirements and test methods
Chirurgische Masken - Anforderungen und Prüfverfahren
Masques chirurgicaux - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 14683:2005
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 14683:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 14683:2006
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SIST EN 14683:2006
EUROPEAN STANDARD
EN 14683
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 11.140
English Version
Surgical masks - Requirements and test methods
Masques chirurgicaux - Exigences et méthodes d'essai Chrirurgische Masken - Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 19 September 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14683:2005: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Classification.6
5 Requirements.6
6 Testing requirements .7
7 Labelling and information to be supplied .7
Annex A (informative) Information for users .8
Annex B (normative) Method for in vitro determination of bacterial filtration efficiency (BFE).9
Annex C (normative) Method for determination of breathability (differential pressure).13
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directive 93/42 concerning medical devices.15
Bibliography .16
2
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SIST EN 14683:2006
EN 14683:2005 (E)
Foreword
This European Standard (EN 14683:2005) 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 May 2006, and conflicting national standards shall be withdrawn at the
latest by May 2006.
This European Standard has been prepared under a mandate 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 European
Standard.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
3
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SIST EN 14683:2006
EN 14683:2005 (E)
Introduction
The transmission of infective agents during surgical procedures in operating theatres and other medical
settings can occur in several ways. Sources are e.g. noses and mouths of the surgical team. The main
intended use of surgical masks is to protect the patients from infective agents from the noses and mouths of
the staff and, in certain situations, additionally to protect the wearer against splashes of potentially
contaminated liquids.
4
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SIST EN 14683:2006
EN 14683:2005 (E)
1 Scope
This European Standard specifies construction and performance requirements, and test methods for surgical
masks intended to limit the transmission of infective agents from staff to patients and (in certain situations
vice-versa) during surgical procedures in operating theatres and other medical settings with similar
requirements.
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 surgical masks.
2 Normative references
The following referenced documents are indispensable for the application of this European Standard. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
(Horizontal Projection of Fixed Volume at a Known Velocity)
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
surgical mask
medical device covering the mouth, nose and chin providing a barrier to minimise the direct transmission of
infective agents between staff and patient
NOTE Transmission of blood-borne agents from patients to staff may occur via splashes.
3.2
bacterial filtration efficiency (BFE)
effectiveness of a surgical mask in capturing aerosol droplets containing bacteria
3.3
differential pressure
pressure drop across a surgical mask under specific conditions of air flow, temperature and humidity
NOTE The differential pressure is an indicator of the "breathability" of the mask.
3.4
colony forming unit (cfu)
particle containing one or more bacterial cells which gives rise to a single bacterial colony on a culture plate
3.5
infective agent
micro-organism that has been shown to cause surgical wound infections or that might cause infection in the
patient or in members of the surgical team
5
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SIST EN 14683:2006
EN 14683:2005 (E)
3.6
surgical procedure
surgical intervention penetrating skin or mucosa, performed by a surgical team under controlled environmental
conditions
3.7
aerosol
suspension of solid, liquid, or solid and liquid, particles in a gaseous medium, the particles having a negligible
falling velocity (see EN 132)
NOTE This velocity is generally considered to be less than 0,25 m/s.
4 Classification
Surgical masks specified in this European Standard are classified into two types according to bacterial
filtration efficiency and differential pressure and each type is further divided according to whether or not the
masks are splash resistant.
5 Requirements
5.1 General
5.1.1 Materials and construction
The surgical mask shall not disintegrate, split or tear during intended use.
5.1.2 Design
The surgical 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.
5.2 Performance requirements
5.2.1 Bacterial filtration efficiency (BFE)
When tested in accordance with Annex B, the bacterial filtration efficiency (BFE) of the surgical mask shall
conform to the minimum value given for the relevant type in Table 1.
5.2.2 Breathability
When tested in accordance with Annex C, the differential pressure of the surgical mask shall conform to the
value given for the relevant type in Table 1.
NOTE 1 If the use of a respiratory protective device as surgical 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 PPE standard(s).
NOTE 2 Differential Pressure is expressed in Pa. 1 Pa equals 9,806 times pressure expressed in mm water.
5.2.3 Splash resistance
When tested in accordance with ASTM F1862, the resistance of the surgical mask to penetration of splashes
of liquid shall conform to the minimum value given for the relevant type in Table 1.
6
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SIST EN 14683:2006
EN 14683:2005 (E)
Table 1 — Performance requirements for surgical masks
Test Type I Type IR Type II Type IIR
Bacterial filtration ≥ 95 ≥ 95 ≥ 98 ≥ 98
efficiency (BFE), (%)
Differential pressure < 29,4 < 49,0 < 29,4 < 49,0
(Pa)
Splash resistance Not required ≥ 120 Not required ≥ 120
pressure (mm Hg)
NOTE Type IR and Type IIR are splash resistant types.
6 Testing requirements
All tests shall be carried out on finished products or samples cut from finished products, if appropriate in their
sterile state.
Unless otherwise specified for a particular test, samples for testing shall be conditioned at (20 ± 2) °C and
(65 ± 2) % relative humidity for the time required to bring them into equilibrium with atmosphere.
7 Labelling and information to be supplied
Annex 1 § 13 of the Medical Devices Directive (93/42/EEC) specifies the information that has to be specified
on the packaging in which the surgical mask is supplied.
The following information shall be supplied in addition:
a) number of this European Standard;
b) type of mask (as indicated in Table 1).
7
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SIST EN 14683:2006
EN 14683:2005 (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. Those droplets quickly evaporate and leave
nuclei suspended in the air. The majority of the nuclei are between 0,5 µm and 12 µm in diameter and
especially the larger droplets can contain micro-organisms 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 surgical masks intended to be used in operating theatres and health care settings with similar
requirements are designed to protect the working environment and not the wearer. When the primary intention
is to protect the wearer from infection, the use of respiratory protective devices should be considered.
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. For this application this European
Standard specifies performance requireme
...
SLOVENSKI STANDARD
SIST EN 14683:2006
01-februar-2006
Kirurške maske – Zahteve in preskusne metode
Surgical masks - Requirements and test methods
Chirurgische Masken - Anforderungen und Prüfverfahren
Masques chirurgicaux - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 14683:2005
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 14683:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 14683:2006
---------------------- Page: 2 ----------------------
SIST EN 14683:2006
EUROPEAN STANDARD
EN 14683
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 11.140
English Version
Surgical masks - Requirements and test methods
Masques chirurgicaux - Exigences et méthodes d'essai Chrirurgische Masken - Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 19 September 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14683:2005: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Classification.6
5 Requirements.6
6 Testing requirements .7
7 Labelling and information to be supplied .7
Annex A (informative) Information for users .8
Annex B (normative) Method for in vitro determination of bacterial filtration efficiency (BFE).9
Annex C (normative) Method for determination of breathability (differential pressure).13
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directive 93/42 concerning medical devices.15
Bibliography .16
2
---------------------- Page: 4 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
Foreword
This European Standard (EN 14683:2005) 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 May 2006, and conflicting national standards shall be withdrawn at the
latest by May 2006.
This European Standard has been prepared under a mandate 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 European
Standard.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
3
---------------------- Page: 5 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
Introduction
The transmission of infective agents during surgical procedures in operating theatres and other medical
settings can occur in several ways. Sources are e.g. noses and mouths of the surgical team. The main
intended use of surgical masks is to protect the patients from infective agents from the noses and mouths of
the staff and, in certain situations, additionally to protect the wearer against splashes of potentially
contaminated liquids.
4
---------------------- Page: 6 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
1 Scope
This European Standard specifies construction and performance requirements, and test methods for surgical
masks intended to limit the transmission of infective agents from staff to patients and (in certain situations
vice-versa) during surgical procedures in operating theatres and other medical settings with similar
requirements.
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 surgical masks.
2 Normative references
The following referenced documents are indispensable for the application of this European Standard. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
(Horizontal Projection of Fixed Volume at a Known Velocity)
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
surgical mask
medical device covering the mouth, nose and chin providing a barrier to minimise the direct transmission of
infective agents between staff and patient
NOTE Transmission of blood-borne agents from patients to staff may occur via splashes.
3.2
bacterial filtration efficiency (BFE)
effectiveness of a surgical mask in capturing aerosol droplets containing bacteria
3.3
differential pressure
pressure drop across a surgical mask under specific conditions of air flow, temperature and humidity
NOTE The differential pressure is an indicator of the "breathability" of the mask.
3.4
colony forming unit (cfu)
particle containing one or more bacterial cells which gives rise to a single bacterial colony on a culture plate
3.5
infective agent
micro-organism that has been shown to cause surgical wound infections or that might cause infection in the
patient or in members of the surgical team
5
---------------------- Page: 7 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
3.6
surgical procedure
surgical intervention penetrating skin or mucosa, performed by a surgical team under controlled environmental
conditions
3.7
aerosol
suspension of solid, liquid, or solid and liquid, particles in a gaseous medium, the particles having a negligible
falling velocity (see EN 132)
NOTE This velocity is generally considered to be less than 0,25 m/s.
4 Classification
Surgical masks specified in this European Standard are classified into two types according to bacterial
filtration efficiency and differential pressure and each type is further divided according to whether or not the
masks are splash resistant.
5 Requirements
5.1 General
5.1.1 Materials and construction
The surgical mask shall not disintegrate, split or tear during intended use.
5.1.2 Design
The surgical 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.
5.2 Performance requirements
5.2.1 Bacterial filtration efficiency (BFE)
When tested in accordance with Annex B, the bacterial filtration efficiency (BFE) of the surgical mask shall
conform to the minimum value given for the relevant type in Table 1.
5.2.2 Breathability
When tested in accordance with Annex C, the differential pressure of the surgical mask shall conform to the
value given for the relevant type in Table 1.
NOTE 1 If the use of a respiratory protective device as surgical 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 PPE standard(s).
NOTE 2 Differential Pressure is expressed in Pa. 1 Pa equals 9,806 times pressure expressed in mm water.
5.2.3 Splash resistance
When tested in accordance with ASTM F1862, the resistance of the surgical mask to penetration of splashes
of liquid shall conform to the minimum value given for the relevant type in Table 1.
6
---------------------- Page: 8 ----------------------
SIST EN 14683:2006
EN 14683:2005 (E)
Table 1 — Performance requirements for surgical masks
Test Type I Type IR Type II Type IIR
Bacterial filtration ≥ 95 ≥ 95 ≥ 98 ≥ 98
efficiency (BFE), (%)
Differential pressure < 29,4 < 49,0 < 29,4 < 49,0
(Pa)
Splash resistance Not required ≥ 120 Not required ≥ 120
pressure (mm Hg)
NOTE Type IR and Type IIR are splash resistant types.
6 Testing requirements
All tests shall be carried out on finished products or samples cut from finished products, if appropriate in their
sterile state.
Unless otherwise specified for a particular test, samples for testing shall be conditioned at (20 ± 2) °C and
(65 ± 2) % relative humidity for the time required to bring them into equilibrium with atmosphere.
7 Labelling and information to be supplied
Annex 1 § 13 of the Medical Devices Directive (93/42/EEC) specifies the information that has to be specified
on the packaging in which the surgical mask is supplied.
The following information shall be supplied in addition:
a) number of this European Standard;
b) type of mask (as indicated in Table 1).
7
---------------------- Page: 9 ----------------------
SIST EN 14683:2006
EN 14683:2005 (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. Those droplets quickly evaporate and leave
nuclei suspended in the air. The majority of the nuclei are between 0,5 µm and 12 µm in diameter and
especially the larger droplets can contain micro-organisms 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 surgical masks intended to be used in operating theatres and health care settings with similar
requirements are designed to protect the working environment and not the wearer. When the primary intention
is to protect the wearer from infection, the use of respiratory protective devices should be considered.
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. For this application this European
Standard specifies performance requireme
...
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