EN 455-2:2024
(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 document 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 document 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
Dieses Dokument legt Anforderungen und Prüfverfahren der physikalischen Eigenschaften medizinischer Handschuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungs /Behandlungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kreuzkontamination für Patient und Anwender bereitgestellt und aufrechterhalten wird.
Dieses Dokument legt keine Losgröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der Verteilung und Kontrolle sehr großer Lose verbunden sein können. Die empfohlene maximale Einzellosgröße 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.
Le présent document 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
Ta dokument določa zahteve in podaja preskusne metode za ugotavljanje fizikalnih lastnosti medicinskih rokavic za enkratno uporabo (tj. operacijskih rokavic in rokavic za pregled/postopek), da se zagotovi in ohrani ustrezna raven zaščite pred navzkrižno kontaminacijo za pacienta in uporabnika.
Ta dokument ne določa velikosti serije. Opozoriti je treba na težave, ki so lahko povezane z razporejanjem in nadzorom zelo velikih serij. Priporočena največja velikost posamezne serije za proizvodnjo je 500.000.
General Information
Relations
Overview
EN 455-2:2024 - published by CEN - defines the requirements and test methods for physical properties of single‑use medical gloves (surgical and examination/procedure gloves). The standard ensures gloves provide and maintain an adequate level of protection against cross‑contamination for both patient and user. Key outcomes include pass/fail criteria for dimensions, mechanical strength and ageing resilience, plus required test reporting and labelling (including date of manufacture).
Key topics and technical requirements
Scope and sampling
- Applies to single‑use medical gloves (surgical and examination/procedure).
- Recommended maximum lot size for production: 500 000 items (lot size not mandated).
- Sampling typically uses 13 test pieces taken from a lot.
Dimensions
- Length and width measurement procedures (suspend glove by middle finger; measure width on flat surface).
- Median dimension requirements specified for surgical and examination glove sizes (Tables 1–2).
Strength and tensile testing
- Force at break is measured on dumb‑bell specimens after conditioning for ≥16 h.
- Test machine crosshead speed: 500 mm/min.
- Thickness measurement and correction: single‑wall and test‑piece thickness checked; if fingertip is >10% thinner, a thickness correction factor is applied to force results.
- Median force‑at‑break thresholds are specified in Table 3 (numeric thresholds such as ≥9.0 N, ≥6.0 N and ≥3.6 N are provided in the standard for different glove categories/materials). Consult the standard for exact mapping of thresholds to glove types and materials.
Ageing / shelf‑life challenge
- Accelerated ageing (challenge) test: packaged gloves exposed for 7 days at (70 ± 2) °C per ISO 188; force‑at‑break is re‑measured to assess performance through shelf life.
Test reporting and labelling
- Test reports must reference EN 455‑2:2024 and include glove type, material, batch code, test methods, results and manufacturer/test lab details.
- Packaging/glove must be labelled with date of manufacture in accordance with EN ISO 15223‑1 and EN ISO 20417.
Applications and users
- Manufacturers of single‑use medical gloves use EN 455-2:2024 to design, validate and verify physical performance and to support CE/MDR compliance.
- Test laboratories implement the specified sampling, conditioning and tensile methods to produce accredited test reports.
- Procurement, quality and regulatory teams in hospitals and distributors use the standard to interpret performance claims and shelf‑life evidence.
- R&D and materials engineers reference the standard when selecting elastomers or thermoplastics to meet minimum mechanical criteria.
Related standards
- EN 455 series: Part 1 (freedom from holes), Part 3 (biological evaluation), Part 4 (shelf life determination)
- EN ISO 15223‑1:2021; EN ISO 20417:2021 (labelling/information)
- ISO 23529 (test specimen preparation) and ISO 188 (accelerated ageing)
EN 455‑2:2024 is harmonised to support conformity with Regulation (EU) 2017/745 (MDR); consult Annex ZA in the standard for details.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za
ugotavljanje fizikalnih lastnosti
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und
Prüfung der physikalischen Eigenschaften
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés
physiques
Ta slovenski standard je istoveten z: EN 455-2:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 455-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-2:2015
English Version
Medical gloves for single use - Part 2: Requirements and
testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour propriétés physiques Teil 2: Anforderungen und Prüfung der physikalischen
Eigenschaften
This European Standard was approved by CEN on 15 April 2024.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Dimensions. 6
4.1 General. 6
4.2 Length. 7
4.3 Width . 7
5 Strength . 8
5.1 General. 8
5.2 Force at break . 8
5.3 Force at break after challenge testing . 11
6 Test report . 11
7 Labelling . 11
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 12
Bibliography . 14
European foreword
This document (EN 455-2:2024) 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 November 2024, and conflicting national standards
shall be withdrawn at the latest by November 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 455-2:2015.
Compared to the previous edition EN 455-2:2015, the following main changes have been introduced:
a) normative references have been revised;
b) subclause 4.2 has been updated with regard to recording the measured length ("median” has been
removed);
c) Clause 5 has been updated;
d) Clause 6 has been updated;
e) Annex ZA has been updated for harmonization under Medical Device Regulation (EU) 2017/745
(MDR).
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
The EN 455 series consists of the following parts under the general title “Medical gloves for single use”:
— Part 1: Requirements and testing for freedom from holes;
— Part 2: Requirements and testing for physical properties;
— Part 3: Requirements and testing for biological evaluation;
— Part 4: Requirements and testing for shelf life determination.
The following part is under development:
— Part 5: Extractable chemical residues.
A list of all parts in a series can be found on the CEN website.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
1 Scope
This document 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 document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements (ISO 15223-1:2021)
EN ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
ISO 23529:2016, Rubber — General procedures for preparing and conditioning test pieces for physical
test methods
ISO 188:2023, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
medical gloves for single use
gloves intended for use in the medical field to protect patient and user from cross-contamination
3.2
surgical gloves
sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of
the index finger rather than lying flat, and intended for use in invasive surgery
3.3
examination gloves
procedure gloves
sterile or non-sterile medical gloves, which can be anatomically shaped, intended for conducting
medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical
material
3.4
lot
collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially
the same time, using the same process, raw materials of the same specifications, common equipment
and packed in the same type of individual container
[SOURCE: EN 455-4:2009, 3.4]
4 Dimensions
4.1 General
When measured as described in 4.2 and 4.3 taking 13 samples from each lot, the median value obtained
for the dimensions shall be as given in Table 1 and Table 2.
Key
w width
l length
Figure 1 — Designation of length and width of gloves
4.2 Length
Measure the length (dimension l, as designated in Figure 1) by freely suspending the glove with the
middle finger on a vertical graduated rule having a rounded tip so as to fit the shape of the finger tip of
the glove. Remove wrinkles and folds without stretching the glove. Record the me
...
Frequently Asked Questions
EN 455-2:2024 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 document 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 document 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 document 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 document 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 455-2:2024 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 455-2:2024 has the following relationships with other standards: It is inter standard links to EN 455-2:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-2:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575, M/575 AMD 2. 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.
You can purchase EN 455-2:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
La norme EN 455-2:2024, intitulée "Gants médicaux à usage unique - Partie 2 : Exigences et essais pour les propriétés physiques", présente un cadre essentiel pour la certification et l'évaluation des gants médicaux à usage unique, notamment les gants chirurgicaux et les gants d'examen/procédure. Cette norme établit des exigences claires et des méthodes d'essai rigoureuses concernant les propriétés physiques de ces dispositifs médicaux, garantissant ainsi un niveau adéquat de protection contre la contamination croisée pour le patient et l’utilisateur tout au long de leur utilisation. L'un des principaux atouts de la norme EN 455-2:2024 est son approche méthodologique, permettant de vérifier que les gants médicaux respectent des critères de performance spécifiques. En définissant des exigences précises, la norme favorise une cohérence dans la fabrication des gants, contribuant ainsi à la sécurité des pratiques médicales. De plus, elle souligne l'importance de la conformité des gants avec des standards de qualité adaptés, essentiels non seulement pour la protection des patients, mais également pour la sécurité des professionnels de santé. Un autre point fort de cette norme réside dans sa prise en compte des défis liés à la production de grands lots de gants. Bien que le document ne détermine pas spécifiquement la taille d'un lot, il attire l'attention sur les complications possibles qui peuvent émerger lors de la distribution et du contrôle des très grands lots. La recommandation d'une taille maximale de lot individuelle pour la production de 500 000 gants est un aspect pratique qui démontre une compréhension des réalités de la gestion de la production à grande échelle. En somme, la norme EN 455-2:2024 est d'une pertinence indéniable dans le secteur des dispositifs médicaux. Elle établit un cadre solide pour l’évaluation des gants médicaux à usage unique, en mettant l'accent sur des exigences et des essais adéquats pour leurs propriétés physiques. Cela renforce non seulement la sécurité des utilisateurs, mais améliore également la confiance envers les produits sur le marché.
The standard EN 455-2:2024 provides a comprehensive framework for assessing the physical properties of single-use medical gloves, specifically surgical and examination/procedure gloves. This standard is crucial in establishing the necessary requirements and testing protocols that ensure these medical gloves deliver sufficient protection against cross-contamination for both healthcare providers and patients. One of the main strengths of this standard lies in its detailed specifications that directly address the physical characteristics of medical gloves. By defining rigorous testing methods, EN 455-2:2024 enhances the reliability of the gloves in clinical settings, promoting safety and effective infection control practices. This standard supports healthcare facilities in selecting appropriate barriers against pathogens, which is essential in maintaining high standards of patient care. Moreover, the standard's focus on the appropriate lot size for production, with a recommended maximum individual lot size of 500,000, reflects an understanding of the complexities involved in the distribution and control of medical gloves. By acknowledging potential issues with very large lots, the document encourages manufacturers to implement more manageable production practices, ultimately contributing to higher quality control and consistency in the product. In the context of regulatory compliance, EN 455-2:2024 is highly relevant as it aligns with maintaining safety and efficacy standards in the healthcare industry. Adherence to this standard not only facilitates international trade by harmonizing quality expectations but also assures users that the medical gloves meet essential performance benchmarks. In summary, EN 455-2:2024 establishes vital requirements and testing methods for single-use medical gloves, reflecting its importance in healthcare safety, manufacturing standards, and regulatory frameworks. This standard is indispensable for promoting best practices in the production and use of medical gloves in various healthcare settings.
Die Norm EN 455-2:2024 legt wichtige Anforderungen und Prüfmethoden für die physikalischen Eigenschaften von Einmalhandschuhen im medizinischen Bereich fest, insbesondere für Operationshandschuhe sowie Untersuchungs- und Verfahrenshandschuhe. Der Hauptzweck dieser Norm besteht darin, sicherzustellen, dass diese Handschuhe in der Lage sind, ein angemessenes Schutzniveau gegen Kreuzkontamination sowohl für den Patienten als auch für den Anwender bereitzustellen. Ein wesentliches Merkmal dieser Norm ist ihre umfassende Definition der Anforderungen, die die physikalischen Eigenschaften der Handschuhe betreffen. Dazu gehören unter anderem die Festigkeit, Dehnbarkeit und das Verhalten gegenüber chemischen Einflüssen. Durch die Einführung klarer Testmethoden stellt die Norm sicher, dass die Handschuhe unter realistischen Bedingungen bewertet werden, was ihre Relevanz und Anwendbarkeit im klinischen Alltag stärkt. Ein weiteres starkes Element der EN 455-2:2024 ist die Berücksichtigung von partiellen Losgrößen bei der Produktion. Obwohl die Norm keine spezifischen Vorgaben zur Größe eines Loses macht, wird die Empfehlung ausgesprochen, dass die maximale individuelle Losgröße 500.000 Stück nicht überschreiten sollte. Diese Maßnahme trägt dazu bei, die Herausforderungen zu minimieren, die mit der Verteilung und Kontrolle von sehr großen Losen verbunden sind, und unterstützt die Hersteller bei der Einhaltung der Qualitätsstandards. Die Relevanz dieser Norm für die Branche ist unbestreitbar, da sie nicht nur den Schutz der Patienten gewährleistet, sondern auch den Gesundheitspersonal ein sicheres Arbeiten ermöglicht. In Zeiten, in denen Infektionsschutz von größter Bedeutung ist, bietet die EN 455-2:2024 eine wertvolle Grundlage für die Herstellung und Prüfung von medizinischen Einmalhandschuhen. Insgesamt betrachtet, bekräftigt die Norm EN 455-2:2024 den hohen Standard der Qualität und Sicherheit im Bereich der medizinischen Handschuhe und bleibt somit ein entscheidendes Dokument für Hersteller und Anwender gleichermaßen. Sie stellt sicher, dass sowohl Patienten als auch medizinisches Personal optimal geschützt werden.
EN 455-2:2024は、使い捨て医療用手袋に関する規格で、その物理的特性に関する要件と試験方法を明確に定めています。この規格は、外科用手袋や検査・処置用手袋を対象としており、患者および使用者に対して交差汚染からの十分な保護を提供し、使用中にそのレベルを維持することを目的としています。 この文書の強みは、物理特性に関する具体的な要件を提示する点にあります。これにより、医療従事者は手袋が適切な保護を提供しているかどうかを確実に判断でき、患者の安全性を高めることが可能です。また、試験方法が定められているため、製造業者はその基準を遵守し、品質管理を徹底することができます。 さらに、この規格は非常に重要であり、特に大規模なロットの分配や管理に伴う課題に対する注意喚起がなされています。最大の個々のロットサイズが500,000と推奨されることで、製造業者にとって実現可能な管理基準が示され、効率的な生産が可能になります。 EN 455-2:2024は、医療分野における安全基準の強化に寄与するものであり、医療用手袋の生産および使用において、重要な指針を提供しています。この規格に基づく製品は、患者および医療従事者の健康を守るために、極めて重要な役割を果たすでしょう。
SIST EN 455-2:2024 표준은 일회용 의료용 장갑의 물리적 특성에 관한 요구사항 및 시험 방법을 규명하는 문서로, 외과용 장갑 및 검사/시술 장갑의 안전성과 신뢰성을 보장하는 데 중점을 두고 있습니다. 이 표준의 주요 목적은 환자와 사용자 모두에게 교차 오염으로부터 적절한 수준의 보호를 제공하고 유지하는 것입니다. 이 표준의 강점 중 하나는 정확하고 명확한 시험 방법을 제공하여 제조업체가 제품의 물리적 특성을 객관적으로 평가할 수 있게 한다는 점입니다. 이를 통해 사용자들은 구매하는 장갑이 기초적인 품질 기준을 충족하는지를 손쉽게 인지할 수 있습니다. 또한, 특정한 로트 크기에 대한 기준이 설정되어 있지 않기 때문에 다양한 제조 환경에 유연하게 대응할 수 있는 장점이 있습니다. 그러나, 500,000개로 제한된 최대 개별 로트 크기는 제조사들이 대규모 생산을 진행할 때 발생할 수 있는 배급 및 관리의 어려움을 감안해야 함을 시사합니다. 이 표준의 적용 범위는 의료 분야에서 일회용 장갑의 사용을 고려할 때 매우 중요합니다. 특히, 감염 예방 및 환자 안전을 중시하는 현대 의료 환경에 부합하는 요구사항을 갖추고 있어, 전 세계 헬스케어 기관에서 필수적으로 참조해야 할 문서로 자리 잡고 있습니다. 이러한 특성 덕분에 SIST EN 455-2:2024은 일회용 의료용 장갑의 제조 및 품질 보증 시스템 내에서 필수적인 기준으로 평가받고 있습니다. 결론적으로, SIST EN 455-2:2024 표준은 일회용 의료용 장갑의 물리적 특성에 대한 명확한 요구사항과 테스트 방법을 제시함으로써, 제품의 품질 및 사용자 안전을 보장하는 데 중대한 역할을 하고 있습니다.
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