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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Frequently Asked Questions
EN 14683:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical face masks - Requirements and test methods". This standard covers: 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.
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.
EN 14683:2014 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14683:2014 has the following relationships with other standards: It is inter standard links to EN 14683:2005, EN 14683:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14683:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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The standard EN 14683:2014 outlines vital specifications for medical face masks, focusing on their construction, design, performance requirements, and test methods. Its primary objective is to limit the transmission of infective agents during surgical procedures and in other medical settings where similar protective measures are necessary. The scope of this European Standard emphasizes the critical role of medical face masks that possess a suitable microbial barrier, underscoring their effectiveness in mitigating the emission of infective agents from the nose and mouth of asymptomatic carriers or patients exhibiting clinical symptoms. One of the notable strengths of EN 14683:2014 is its comprehensive nature; it covers not only the essential design and construction criteria but also includes stringent performance requirements that ensure the masks provide adequate protection in medical environments. The introduction of rigorous test methods within the standard further adds to its credibility, allowing manufacturers to verify that their products meet the established safety and efficacy benchmarks. The relevance of EN 14683:2014 in today's healthcare landscape cannot be overstated, particularly in light of recent global health crises that have highlighted the importance of effective infection control measures. The standard serves as a critical guideline for both manufacturers and healthcare providers, ensuring that medical face masks used in clinical settings effectively safeguard against the transmission of infectious diseases. It is important to note that this standard specifically excludes masks intended solely for the personal protection of staff, thereby differentiating medical face masks from other types of respiratory protection PPE. This clarity is essential for proper compliance and usage within medical facilities. Additionally, Annex A of the standard provides valuable information for users of medical face masks, further enhancing its utility in real-world applications. In summary, EN 14683:2014 stands as a foundational document in the realm of medical face masks, combining regulatory rigor with practical relevance to promote safety in healthcare environments.
EN 14683:2014は、医療用マスクの構造、デザイン、性能要件、および試験方法について具体的に規定している重要な欧州標準です。この標準は、外科手術や同様の医療環境において、スタッフから患者への感染症の伝播を制限するために設計された医療用マスクに適用されます。特に、適切な微生物バリアを備えた医療用マスクは、無症状のキャリアや臨床症状を有する患者の鼻や口からの感染性物質の排出を減少させることにも効果的です。 この標準の強みは、その明確な要件設定にあり、医療現場での使用に特化したマスクの安全性と効果を保証します。具体的には、感染拡大を防ぐための基準を提供することで、医療従事者および患者双方の安全を確保します。また、試験方法が明示されているため、製造業者は自社のマスクが基準に適合しているかどうかを確認しやすく、結果として市場に信頼性の高い製品を提供できます。 さらに、EN 14683:2014は、個人保護具としての使用に限定されないことを明確に示しており、医療従事者の個人的な防護に特化したマスクとは異なることに注意が必要です。この点により、医療現場での正しい用途を理解する手助けとなり、適切な製品を選択するためのガイドラインとなります。附属書Aにおいては、医療用マスクの利用者向けの情報も提供されており、さらなる利便性を支援しています。 総じて、EN 14683:2014は、医療制度における感染防止策として非常に重要な文書であり、臨床環境におけるマスクの設計と使用の標準化に寄与しています。その適用範囲と要求される性能基準により、医療業界はしっかりとした基盤の上で患者と医療従事者の安全を守ることができます。
SIST EN 14683:2014 표준은 의료용 마스크에 대한 요구사항 및 시험 방법을 다루고 있으며, 이 표준의 적용 범위는 수술 절차 및 유사한 요구사항을 가진 기타 의료 환경에서 직원으로부터 환자로의 감염성 병원체 전파를 제한하기 위한 것입니다. 이 표준은 의료용 마스크의 구조, 디자인, 성능 요구사항 그리고 시험 방법을 포괄적으로 규정하고 있습니다. 이 표준의 주요 강점 중 하나는 마스크의 적절한 미생물 장벽을 설명하고, 무증상 보균자나 임상 증상을 가진 환자의 코와 입에서 감염성 병원체의 방출을 감소시키는 데 효과적임을 입증하고 있다는 점입니다. 따라서 SIST EN 14683:2014는 의료 환경에서 감염 예방에 중요한 역할을 합니다. 또한, 이 유럽 표준은 직원의 개인 보호를 위한 마스크에는 적용되지 않으며, 이는 특정한 목적과 활용 사례에 맞는 기준을 제시하는 데 중점을 둡니다. 부록 A에서는 의료용 마스크의 사용자에게 유용한 정보를 제공하여 이해를 돕고, 마스크 사용의 효과성을 더욱 높일 수 있도록 합니다. 결론적으로, SIST EN 14683:2014 표준은 의료용 마스크의 요구사항을 규명함으로써, 감염병의 전파를 줄이고 안전한 의료 환경을 만드는 데 중대한 기여를 한다는 점에서 그 중요성이 강조됩니다. 이 문서는 의료 종사자와 환자 모두에 대한 보호 장치로서 필수적인 기준을 제시하여, 이에 따라 관련 제품 개발 및 적용에 있어 높은 가치를 지니고 있습니다.
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