EN 14683:2005

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 à 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 à la protection individuelle des membres de l’équipe médicale.
NOTE 1   Il existe des normes relatives à l’utilisation d’équipements de protection personnelle des voies respiratoires.
NOTE 2   L’Annexe A fournit des informations à destination des utilisateurs des masques chirurgicaux.

Kirurške maske – Zahteve in preskusne metode

General Information

• Status: Withdrawn
• Publication Date: 08-Nov-2005
• Withdrawal Date: 30-May-2006
• 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: 26-Mar-2014
• Completion Date: 26-Mar-2014
• 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 14683:2006 - Surgical masks - Requirements and test methods

Relations

• Replaced By: EN 14683:2014 - Medical face masks - Requirements and test methods
• Effective Date: 12-Jun-2010

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
lat
...

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
...