EN 455-2:2015
(Main)Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medical gloves for single use - Part 2: Requirements and testing for physical properties
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften
Diese Norm legt Anforderungen und Prüfmethoden der physikalischen Eigenschaften medizinischer Hand-schuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungs-/Behandlungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kontamination für Patient und Anwender gewährleistet und aufrechterhalten wird.
Diese Norm legt keine Chargengröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der Verteilung und Kontrolle sehr großer Chargen verbunden sein können. Die empfohlene maximale Einzelchargengröße für die Herstellung beträgt 500 000.
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés physiques
La présente Norme européenne spécifie les exigences et méthodes d'essai relatives aux propriétés physiques des gants médicaux non réutilisables (c'est-à-dire des gants de chirurgie et des gants d'examen et de soins), afin de garantir qu'ils assurent et conservent pendant toute la durée de leur utilisation un niveau de protection suffisant contre toute contamination croisée, à la fois pour le patient et pour l'utilisateur.
La présente Norme ne spécifie pas la taille du lot. L’attention est attirée sur les difficultés pouvant être liées à la distribution et à la vérification de lots de volume très important. La taille maximale recommandée d’un lot de production est de 500 000 unités.
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti
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Frequently Asked Questions
EN 455-2:2015 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 2: Requirements and testing for physical properties". This standard covers: This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
EN 455-2:2015 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 455-2:2015 has the following relationships with other standards: It is inter standard links to EN 455-2:2009+A2:2013, EN 455-2:2024, EN 455-2:2009+A1:2011, EN 455-2:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-2:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. 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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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnostiMedizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen EigenschaftenGants médicaux non réutilisables - Partie 2: Propriétés physiques: exigences et essaisMedical gloves for single use - Part 2: Requirements and testing for physical properties11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 455-2:2015SIST EN 455-2:2015en,fr,de01-julij-2015SIST EN 455-2:2015SLOVENSKI
STANDARDSIST EN 455-2:2010+A2:20131DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2
April 2015 ICS 11.140 Supersedes EN 455-2:2009+A2:2013English Version
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés physiques
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften This European Standard was approved by CEN on 24 January 2015.
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 © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2015 ESIST EN 455-2:2015
Foreword .3 1 Scope .4 2 Normative references .4 3 Terms and definitions .4 4 Dimensions .5 4.1 General .5 4.2 Length .5 4.3 Width .5 5 Strength .7 5.1 General .7 5.2 Force at break .7 5.3 Force at break after challenge testing .9 6 Test report . 10 7 Labelling . 10 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 11
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EN 455-2:2015は、使い捨て医療用手袋に関する欧州規格の重要な部分であり、その物理的特性に関する要求事項および試験方法を明確に定めています。この文書は外科用手袋や検査/処置用手袋を含む使い捨て医療用手袋の適切なレベルの保護を確保するための基準を示しており、患者と使用者の両方に対して交差汚染からの保護を維持することを目的としています。 この標準の強みは、まずその明確な要求事項にあります。文書は、物理的特性に関する試験方法を詳細に説明しており、製造者が適切な品質管理を行うための指針を提供しています。また、試験の標準化により、医療分野で使用される手袋の信頼性が強化され、均一な品質を確保することが可能です。 さらに、EN 455-2:2015は、非常に大きなロットの分配や管理に関連する課題にも注意を促しています。生産における推奨最大ロットサイズが50万個であることから、製造者は管理しやすい範囲内で供給を行うことが奨励され、これにより供給チェーン全体の効率性が向上します。この点は、製品の一貫性と安全性を確保するために非常に重要です。 標準の適用範囲と要求事項は、医療分野での利用において特に重要であり、医療従事者と患者双方の安全を保障するための基盤となっています。したがって、EN 455-2:2015は、医療用手袋に関する規制の中で非常に関連性の高い文書であり、業界全体の品質向上に貢献するものであると言えます。
Die Norm EN 455-2:2015 ist ein wichtiger Bestandteil in der Regelung von medizinischen Handschuhen für den einmaligen Gebrauch. Sie legt spezifische Anforderungen und Prüfmethoden für die physikalischen Eigenschaften dieser Handschuhe fest, insbesondere für chirurgische Handschuhe sowie Prüf- und Verfahrenhandschuhe. Die Norm zielt darauf ab, ein angemessenes Niveau an Schutz vor Kreuzkontamination sowohl für den Patienten als auch für den Anwender sicherzustellen. Ein herausragendes Merkmal dieser Norm ist ihre Fokussierung auf die physikalischen Eigenschaften, die für die Sicherheit und Wirksamkeit von medizinischen Handschuhen entscheidend sind. Dabei werden unterschiedliche Testmethoden beschrieben, um die Qualität und die Schutzfunktionen der Handschuhe zu überprüfen. Die strengen Anforderungen stellen sicher, dass nur hochwertige Produkte auf den Markt gelangen, wodurch das Risiko von Infektionen und anderen medizinischen Komplikationen verringert wird. Ein weiterer wichtiger Aspekt der EN 455-2:2015 ist ihre Relevanz im klinischen Alltag. Die Norm liefert ein bewährtes Rahmenwerk, das Herstellern und Gesundheitsdienstleistern hilft, die erforderlichen Sicherheitsstandards einzuhalten. Durch das Festlegen von Prüfmethoden und Anforderungen trägt die Norm maßgeblich dazu bei, das Vertrauen in die von Fachkräften verwendeten Produkte zu stärken. Die Norm macht auch auf die Herausforderungen aufmerksam, die mit der Verteilung und Kontrolle sehr großer Chargen verbunden sind. Die empfohlene maximale Einzel-Lot-Größe von 500.000 ermöglicht eine effektive Produktion und Qualitätssicherung, ohne die Integrität der Tests zu gefährden. Diese Vorgaben unterstützen die Hersteller, eine hohe Konsistenz und Kontrolle über die Produkte zu gewährleisten. Insgesamt ist die EN 455-2:2015 daher nicht nur eine technische Richtlinie, sondern hat auch eine grundlegende Bedeutung für die Sicherheit in der Medizin. Sie ermöglicht es, qualitativ hochwertige, sichere medizinische Handschuhe zu produzieren, die sowohl Patienten als auch medizinisches Personal effektiv schützen.
EN 455-2:2015 표준은 의료용 일회용 장갑의 물리적 특성에 대한 요구사항과 시험 방법을 규정하고 있으며, 특히 수술용 장갑과 검사/시술용 장갑의 품질을 보장하기 위해 마련되었습니다. 이 표준은 환자와 사용자 모두에게 감염 전파로부터 적절한 수준의 보호를 제공하는 것을 목표로 하고 있습니다. 이 표준의 범위는 일회용 의료용 장갑의 사용 중에 요구되는 물리적 특성을 다루고 있으며, 이를 통해 의료 환경에서의 안전성을 높이고 건강 관리의 질을 향상시킬 수 있습니다. 또한, EN 455-2:2015는 대규모 생산에서 발생할 수 있는 유통 및 관리의 어려움에 주의할 것을 강조하며, 생산을 위한 권장 최대 개별 로트 크기를 50만 개로 정하고 있습니다. 이는 품질 관리의 용이성을 높이고, 효과적인 재고 관리에 기여합니다. 표준의 강점 중 하나는 장갑의 물리적 특성에 대한 명확한 요구사항을 설정함으로써 제조사들과 사용자가 더 높은 품질의 제품을 확보할 수 있도록 돕는 것입니다. 또한, 이 표준은 안전성을 확보하기 위한 검증된 시험 방법을 제시하여 제품의 신뢰성을 증진시키는 데 기여합니다. 이러한 요구사항과 시험 방법은 의료 환경에서 일어날 수 있는 다양한 위협으로부터 보호하는 데 필수적입니다. EN 455-2:2015 표준은 의료 분야에서 일회용 장갑의 사용에 있어 중요한 참고자료로 기능하며, 감염 예방 및 환자 안전성 확보를 위한 필수적인 기준을 제공하고 있습니다. 따라서 의료 기기 산업에 종사하는 모든 관련자가 반드시 숙지해야 할 중요한 표준으로 자리잡고 있습니다.
La norme EN 455-2:2015, intitulée "Gants médicaux à usage unique - Partie 2 : Exigences et essais pour les propriétés physiques", énonce des exigences précises et des méthodes d'essai relatives aux propriétés physiques des gants médicaux à usage unique, y compris les gants chirurgicaux et les gants d'examen ou de procédure. Ce cadre normatif est essentiel pour garantir un niveau adéquat de protection contre la contamination croisée tant pour le patient que pour l'utilisateur. L'une des forces notables de cette norme réside dans sa capacité à standardiser les exigences en matière de sécurité et d'efficacité des gants médicaux, ce qui contribue grandement à la sécurité des soins de santé. En établissant des critères précis, elle permet non seulement de protéger les utilisateurs, mais aussi de renforcer la confiance des patients dans les dispositifs médicaux qui leur sont appliqués. En outre, bien que la norme ne spécifie pas la taille d'un lot de gants, elle met en lumière l'importance de la gestion des lots, particulièrement lorsque ceux-ci peuvent atteindre de grandes quantités. Cette considération est cruciale dans le cadre de la production de gants médicaux, où un lot maximum recommandé de 500 000 unités est proposé pour faciliter la distribution et le contrôle de qualité. La pertinence de la norme EN 455-2:2015 dans le paysage de la santé moderne ne saurait être sous-estimée. Avec l'augmentation des préoccupations liées aux infections nosocomiales et aux contaminants, cette norme offre un angle de prévention qui est devenu indispensable. En intégrant des méthodologies éprouvées et adaptées, elle s'affirme comme un pilier dans l'assurance qualité des gants médicaux à usage unique.
The standard EN 455-2:2015 is a crucial document that delineates the requirements and testing methods for the physical properties of single-use medical gloves, specifically surgical and examination/procedure gloves. By establishing these benchmark criteria, the standard ensures that medical gloves provide an adequate level of protection against cross-contamination, safeguarding both patients and healthcare providers throughout their use. One of the primary strengths of this standard lies in its comprehensive approach to testing the physical properties of gloves. It covers essential aspects such as tensile strength, elongation, and puncture resistance, all of which are critical for ensuring the durability and reliability of these protective items in a medical setting. The rigorous testing protocols outlined in EN 455-2:2015 help to standardize product quality across manufacturers, thereby enhancing the overall safety of medical procedures that rely on these essential tools. Furthermore, the standard's focus on single-use gloves is highly relevant in the context of infection control practices. With the ongoing emphasis on minimizing cross-contamination risks in healthcare environments, EN 455-2:2015 addresses a critical gap by ensuring that the gloves used are not only effective but also meet strict quality assurance criteria. This relevance is further underscored by the acknowledgment of lot sizes, as distributing and controlling large lots poses unique challenges that can impact the consistency and reliability of glove quality. Ultimately, the EN 455-2:2015 standard stands out as a vital component in the regulatory framework for medical gloves. It not only enhances the safety and efficacy of medical practices but also instills confidence in healthcare professionals and patients alike regarding the protective measures employed within medical contexts.
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