EN 14683:2014
(Main)Medical face masks - Requirements and test methods
Medical face masks - Requirements and test methods
This European Standard 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
Diese Europäische Norm legt konstruktive Gestaltung, Entwurf, Leistungsanforderungen sowie Prüfverfahren für medizinische Gesichtsmasken fest, die dazu dienen, die Übertragung infektiöser Keime vom Personal auf Patienten während chirurgischer Eingriffe und sonstigen medizinischen Einrichtungen 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
La présente Norme européenne spécifie les exigences de fabrication, de conception et de performances, 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 vers les patients et aussi lors d’actes chirurgicaux et pour d’autres actes médicaux dont les exigences sont similaires. Un masque à usage médical présentant une barrière anti-microbienne 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 destinés exclusivement à la protection individuelle des membres de l’équipe.
NOTE 1 Il existe des normes relatives à l’utilisation des équipements de 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
EN 14683 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 ne velja za maske, ki so namenjene izključno osebni zaščiti zaposlenih.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske maske za obraz - Zahteve in preskusne metodeMedizinische Gesichtsmasken - Anforderungen und PrüfverfahrenMasques à usage médical - Exigences et méthodes d'essaiMedical face masks - Requirements and test methods11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 14683:2014SIST EN 14683:2014en,fr,de01-julij-2014SIST EN 14683:2014SLOVENSKI
STANDARDSIST EN 14683:20061DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14683
March 2014 ICS 11.140 Supersedes EN 14683:2005English Version
Medical face masks - Requirements and test methods
Masques à usage médical - Exigences et méthodes d'essai Medizinische Gesichtsmasken - Anforderungen und Prüfverfahren This European Standard was approved by CEN on 4 February 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14683:2014 ESIST EN 14683:2014
Foreword .3 Introduction .4 1 Scope .5 2 Normative references .5 3 Terms and definitions .5 4 Classification .6 5 Requirements .7 5.1 General .7 5.2 Performance requirements .7 6 Labelling and information to be supplied .8 Annex A (informative)
Information for users .9 Annex B (normative)
Method for in-vitro determination of bacterial filtration efficiency (BFE). 10 B.1 Principle . 10 B.2 Reagents and materials . 10 B.3 Apparatus . 11 B.4 Test specimens . 11 B.5 Preparation of bacterial challenge . 11 B.6 Procedure . 12 B.7 Calculation of bacterial filtration efficiency . 12 B.8 Test report . 12 Annex C (normative)
Method for determination of breathability (differential pressure) . 15 C.1 Principle . 15 C.2 Apparatus . 16 C.3 Test specimens . 16 C.4 Procedure . 16 C.5 Calculation of differential pressure . 16 C.6 Test report . 16 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 18 Bibliography . 19 SIST EN 14683:2014
See EN 132. Note 2 to entry: This velocity is generally considered to be less than 0,25 m/s. 3.9 filter material used for mechanical and physical separation or deposition of aerosol particles (liquid or solid) from the inhaled and exhaled air 3.10 splash resistance ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure 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. SIST EN 14683:2014
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