SIST EN 14683:2014
(Main)Medical face masks - Requirements and test methods
Medical face masks - Requirements and test methods
EN 14683 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.
Medizinische Gesichtsmasken - Anforderungen und Prüfverfahren
Diese Europäische Norm legt konstruktive Gestaltung, Leistungsanforderungen sowie Prüfverfahren für medizinische Gesichtsmasken fest, die dazu dienen, die Übertragung infektiöser Keime vom Personal auf Patienten und während chirurgischer Eingriffe in Operationssälen 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.
General Information
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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
SIST EN 14683:2014
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
EN 14683:2014 (E) 2 Contents Page
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
EN 14683:2014 (E) 3 Foreword This document (EN 14683:2014) 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 2014 and conflicting national standards shall be withdrawn at the latest by September 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14683:2005. In respect to EN 14683:2005, the following changes have been made: a) change/extension of title and scope to the more general and broader use for medical face masks; b) adjustment to ISO 22609 concerning the request for resistance to liquid splashes; c) addition of requirements for microbiological purity and general biocompatibility; d) adjustment of Table 1 on performance requirements for medical face masks; e) update of Annex A on user information; f) complete revision of Annex B on method for in-vitro determination of the bacterial filter performance in particular with regard to the testing conditions and the structure of the test apparatus; g) complete editorial revision, including update of all normative references, the Bibliography and Annex ZA on the relationships to the EU Directive 93/42/EEC. This document 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 document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 14683:2014
EN 14683:2014 (E) 4 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 and viable particles. 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. SIST EN 14683:2014
EN 14683:2014 (E) 5 1 Scope 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. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1) EN ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5) EN ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization (ISO 10993-10) EN ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1) ISO 22609, 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. 3.1 medical face mask medical device covering the mouth and nose providing a barrier to minimise the direct transmission of infective agents between staff and patient Note 1 to entry: Transmission of blood-borne agents from patients to staff may occur via splashes. 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 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 SIST EN 14683:2014
EN 14683:2014 (E) 6 Note 1 to entry: The differential pressure is an indicator of the "breathability" of the mask. 3.4 colony forming unit (cfu) unit by which the culturable number of micro-organisms is expressed Note 1 to entry: The culturable number is the number of micro-organisms, single cells or aggregates, able to form colonies on a solid nutrient medium. 3.5 cleanliness freedom from unwanted foreign matter Note 1 to entry: Such matter can be micro-organisms, organic residues or particulate matter. 3.5.1 cleanliness — microbial 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". 3.5.2 cleanliness — particulate matter freedom from particles that are contaminating a material and can be released but are not generated by mechanical impact 3.6 infective agent micro-organism that has been shown to cause surgical wound infections or that might cause infection in the patient, members of staff or other 3.7 surgical procedure surgical intervention penetrating skin or mucosa, performed by a surgical team under controlled environmental conditions 3.8 aerosol gaseous suspension of solid and/or liquid particles, the particles having a negligible falling velocity Note 1 to entry:
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
EN 14683:2014 (E) 7 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 (absence of particulate matter). 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, if applicable in their sterile state. 5.2.2 Bacterial filtration efficiency (BFE) When tested in accordance with Annex B, the bacterial filtration efficiency (BFE) of the medical face mask shall conform to the minimum value given for the relevant type in Table 1. 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. 5.2.4 Splash resistance When tested in accordance with ISO 22609 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 the bioburden of the medical mask shall be ≤ 30 cfu/g tested (see Table 1). NOTE EN ISO 11737-1 specifies requirements and provides guidance for the enumeration and microbial characterisation 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, follow the procedure below: The number of masks that shall be tested is minimum 5 (five), but can be greater if necessary to allow for an AQL of 4 %. SIST EN 14683:2014
EN 14683:2014 (E) 8 Weigh each mask prior testing. The full mask is aseptically removed from the packaging and placed in a sterile 500 ml bottle containing 300 ml of extraction liquid (1 g/l Peptone, 5 g/l NaCl & 2 g/l polysorbate surfactant 20 [e.g. Tween 20, Alkest TW 20]). The bottle is laid down on an orbital shaker and shaken for 5 min at 250 rpm. After this extraction step, 100 ml of the extraction liquid is filtered through a 0,45 µ filter and laid down on a TSA plate for the total viable aerobic microbial count. Another 100 ml aliquot of the same extraction liquid is filtered in the same way and the filter plated on Sabouraud Dextrose agar (SDA) with chloramphenicol for fungi enumeration. The plates are incubated for 3 days at 30 °C and 7 d
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