SIST 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.
Frequently Asked Questions
SIST EN 455-2:2024 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST 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.
SIST EN 455-2:2024 has the following relationships with other standards: It is inter standard links to SIST EN 455-2:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 455-2:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745, EUR-PUB; 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 SIST 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 SIST standards.
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
...
La norme SIST EN 455-2:2024 se concentre sur l'évaluation des propriétés physiques des gants médicaux à usage unique, en particulier les gants chirurgicaux et les gants d'examen/procédure. Cette norme est essentielle pour garantir un niveau adéquat de protection contre la contamination croisée, tant pour le patient que pour l'utilisateur, ce qui en fait un document crucial dans le secteur de la santé. Le champ d'application de cette norme est clairement défini, offrant des exigences spécifiques et des méthodes d'essai pour les propriétés physiques des gants médicaux. Cela assure non seulement la conformité des produits aux standards de sécurité, mais renforce également la confiance des professionnels de santé dans l'utilisation de ces équipements de protection. Parmi les points forts de cette norme, on note sa pertinence pour le contrôle de la qualité des gants médicaux, ainsi que son approche rigoureuse pour mesurer les performances physiques. La norme aborde des aspects critiques tels que l'élasticité, la résistance à la déchirure, et la résistance à la perforation, éléments indispensables pour minimiser les risques liés à l'utilisation de gants dans des situations cliniques. De plus, la norme attire l'attention sur les défis que pose la distribution et le contrôle de très grands lots, tout en suggérant une taille maximale de lot de 500 000 unités pour la production. Cela témoigne d'un effort pour garantir que la production de gants médicaux reste efficace, tout en maintenant des standards de qualité élevés. En intégrant des exigences précises et des méthodes d'essai rigoureuses, SIST EN 455-2:2024 représente une avancée significative pour les fabricants et les utilisateurs de gants médicaux à usage unique. Elle répond aux exigences contemporaines en matière de sécurité et de qualité, ce qui accentue son importance dans le paysage réglementaire et professionnel de la santé.
SIST EN 455-2:2024 표준은 단일 사용을 위한 의료용 장갑의 물리적 특성에 대한 요구 사항과 시험 방법을 규정하고 있습니다. 이 표준의 주요 초점은 수술 장갑과 검사/절차 장갑의 사용 중 교차 오염으로부터 환자와 사용자에게 적절한 보호 수준을 제공하고 유지하는 것입니다. 이를 통해 의료 환경에서 발생할 수 있는 감염의 위험을 최소화하고, 사용자와 환자 모두에게 안전한 의료 서비스를 보장하고자 합니다. 이 표준의 강점은 명확한 요구 사항 제시와 더불어 실질적인 테스트 방법을 제공함으로써 제조자와 사용자 간의 신뢰를 구축할 수 있는 점입니다. 특히, 표준은 의료용 장갑의 물리적 특성을 평가하기 위한 체계적인 접근 방식을 강조하여, 장갑의 품질을 유지하고 성능을 보장하는 데 중요한 역할을 합니다. 이는 의료 서비스의 안전성과 효율성을 크게 향상시킬 수 있습니다. 또한, 이 문서는 개별 생산 로트의 최대 크기에 대해 500,000개로 권장하고 있으나, 매우 큰 로트의 유통 및 관리에서 발생할 수 있는 어려움에 대해 주의를 기울일 것을 권장하고 있습니다. 따라서, 해당 표준의 적용은 장갑 생산 과정에서의 품질 관리와 효율성을 더 강화하는 데 기여할 것입니다. SIST EN 455-2:2024 표준은 의료 분야에서의 응용 가능성을 높이고, 장갑의 물리적 특성이 가져오는 안전성을 강조하며, 궁극적으로 환자와 사용자 보호에 기여하는 중요한 기준으로 자리 잡고 있습니다. 이러한 점에서, 이 표준은 의료용 장갑의 품질과 신뢰성을 평가하고 개선하기 위한 필수적인 도구입니다.
Die SIST EN 455-2:2024 ist ein bedeutendes Dokument, das die Anforderungen und Prüfmethoden für die physikalischen Eigenschaften von Einweg-Medizin-Handschuhen, wie chirurgischen Handschuhen und Untersuchungs-/Verfahrenshandschuhen, spezifiziert. Der Schwerpunkt dieser Norm liegt darauf, sicherzustellen, dass diese Handschuhe während ihrer Verwendung ein angemessenes Schutzniveau gegen Kreuzkontamination sowohl für den Patienten als auch für den Anwender bieten. Ein herausragendes Merkmal dieser Norm ist die detaillierte Beschreibung der verschiedenen physikalischen Eigenschaften, die erfüllt werden müssen, um die Qualität und Sicherheit der Handschuhe zu gewährleisten. Dies umfasst Aspekte wie Zugfestigkeit, Dehnbarkeit und Wasserundurchlässigkeit, die für die Leistungsfähigkeit der Handschuhe entscheidend sind. Die klare Definition dieser Anforderungen trägt dazu bei, dass Hersteller von medizinischen Handschuhen sicherstellen können, dass ihre Produkte die notwendigen Schutzstandards einhalten. Besonders erwähnenswert ist, dass die Norm die Herausforderungen anspricht, die mit der Verteilung und Kontrolle von sehr großen Chargen verbunden sein können. Durch die Empfehlung einer maximalen Stückzahl von 500.000 pro Charge wird die Handhabbarkeit verbessert und das Risiko von Qualitätsproblemen verringert. Dies ist von großer Bedeutung für die gesamte Branche, da eine besser kontrollierte Produktion zu einem höheren Sicherheitsstandard führt. Insgesamt zeigt die SIST EN 455-2:2024 durch ihre präzisen Anforderungen und Prüfmethoden eine hohe Relevanz in der medizinischen Praxis. Ihre Stärken liegen in der Gewährleistung von Sicherheit und Qualität der Einweg-Medizin-Handschuhe, wodurch das Vertrauen der Anwender in die Produkte gestärkt wird. Die Norm stellt somit einen wichtigen Beitrag zur Verbesserung der Patientensicherheit und der allgemeinen Hygiene in medizinischen Einrichtungen dar.
SIST EN 455-2:2024は、使い捨ての医療用手袋、特に外科用手袋や検査・処置用手袋に関する物理的特性の要件と試験方法を定めた文書です。この標準は、患者とユーザーの両方に対して、交差汚染からの適切な保護レベルを提供し、使用中にその水準を維持することを目的としています。 この標準の強みは、医療用手袋の物理的特性に関する具体的な要件が明確に定義されていることです。これにより、製造業者は品質基準を遵守しやすく、医療現場における安全性を確保できるようになります。また、標準では、500,000の個別ロットサイズが推奨されており、大規模なロットの配布および管理に伴う課題にも配慮されています。 さらに、SIST EN 455-2:2024は、使い捨て医療用手袋の安全性と効率性を向上させるための重要な指針となるため、医療機関や製造者にとって非常に関連性の高い文書です。特に、医療現場での清潔性や感染症の予防において、物理的特性が重要な役割を果たすことを考えると、この標準の存在は非常に重要です。
The standard SIST EN 455-2:2024 offers a comprehensive framework for the requirements and testing of the physical properties of single-use medical gloves, specifically surgical gloves and examination/procedure gloves. This document is crucial for ensuring the safety and efficacy of medical gloves, as it lays out specific testing methods that ascertain the gloves' ability to provide adequate protection against cross-contamination for both healthcare providers and patients. One of the key strengths of SIST EN 455-2:2024 is its focus on physical properties, which are critical for maintaining the integrity of medical gloves during use. This includes attributes such as tensile strength, elongation, and barrier performance, all essential for the gloves to function appropriately in clinical environments. By adhering to these defined requirements, manufacturers can ensure that their products meet safety standards, ultimately protecting users and patients alike. Furthermore, the standard's inclusion of guidelines related to lot size, although not specifying an exact size, addresses potential challenges in distribution and quality control. The recommendation of a maximum individual lot size of 500,000 ensures that production batches remain manageable, allowing for more rigorous testing and oversight. This recommendation not only supports the manufacturers in maintaining high-quality output but also aids regulatory bodies in monitoring compliance and safety across different batches of medical gloves. SIST EN 455-2:2024 is highly relevant in today's healthcare landscape, especially in the context of heightened awareness regarding infection control and safety measures due to recent global health challenges. The standard not only elevates the quality of single-use medical gloves but also fosters trust among healthcare professionals and patients regarding the effectiveness of protective gear. Understanding and implementing the criteria set forth in this document are essential for any organization involved in the manufacture, distribution, or use of medical gloves.
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