EN 455-1:2020+A1:2022
(Main)Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: Anforderungen und Prüfung auf Dichtheit
Dieses Dokument legt Anforderungen und Prüfung auf Dichtheit von medizinischen Handschuhen zum einmaligen Gebrauch fest.
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de l'absence de trous
Le présent document spécifie des exigences et indique la méthode d’essai permettant de déterminer l'absence de trous dans les gants médicaux non réutilisables.
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za ugotavljanje odsotnosti lukenj (vključuje dopolnilo A1)
Ta dokument določa zahteve in podaja preskusne metode za medicinske rokavice za enkratno uporabo, s katerimi se ugotavlja odsotnost lukenj.
General Information
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Frequently Asked Questions
EN 455-1:2020+A1:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 1: Requirements and testing for freedom from holes". This standard covers: This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
EN 455-1:2020+A1:2022 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 455-1:2020+A1:2022 has the following relationships with other standards: It is inter standard links to EN 455-1:2020+A2:2024, EN 455-1:2020/prA1, EN 455-1:2020, EN 455-1:2020+A1:2022/FprA2. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN 455-1:2020+A1:2022 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.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2022
Nadomešča:
SIST EN 455-1:2020
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj (vključuje dopolnilo A1)
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: Anforderungen und
Prüfung auf Dichtheit
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de
l'absence de trous
Ta slovenski standard je istoveten z: EN 455-1:2020+A1:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 455-1:2020+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2020
English Version
Medical gloves for single use - Part 1: Requirements and
testing for freedom from holes
Gants médicaux non réutilisables - Partie1 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour la détection de l'absence de trous Teil 1: Anforderungen und Prüfung auf Dichtheit
This European Standard was approved by CEN on 13 April 2020 and includes Amendment 1 approved by CEN on 16 December
2021.
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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020+A1:2022 E
worldwide for CEN national Members.
EN 455-1:2020+A1 :2022 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirement . 4
5 Water tightness test for detection of holes . 4
5.1 Referee testing . 4
5.2 Routine testing . 5
6 Sampling, inspection level and AQL. 5
7 Test report . 5
Annex A (informative) Guidance on relationship between this European Standard and the
General Safety and Performance Requirements of Regulation (EU)
2017/745 [OJ L 117] aimed to be covered . 7
Bibliography . 8
European foreword
This document (EN 455-1:2020+A1:2022) 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 August 2022, and conflicting national standards shall
be withdrawn at the latest by August 2022.
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 455-1:2020".
This document includes Amendment 1 approved by CEN on 23 February 2022.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
In comparison with the previous 2000 edition, the following main changes have been introduced to the
2020 edition:
a) The term 3.1 “medical gloves for single-use” has been amended by a Note to entry;
b) The term 3.2 “hole” has been added;
c) In 5.1 the referee testing has been enhanced to cover the issue on extension of the glove when it is
filled with water;
d) In Clause 6 the first paragraph has been slightly changed to accommodate the EU commission rules
for referencing ISO standards which are not available as EN standards;
e) Due to that there is currently no standardization request by the EU commission for this part of
EN 455 the harmonization process to provide presumption of conformity to the Medical Device
Regulation (MDR) cannot be applied. However, to provide at least guidance on the relationship
between this European Standard and the General Safety and Performance Requirements of
Regulation (EU) 2017/745 [OJ L 117] aimed to be covered, an Annex A has been added.
EN 455 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.
According to the CEN-CENELEC Internal Regulations, the national standard
...
La norme SIST EN 455-1:2020+A1:2022 est un document essentiel pour les professionnels de la santé, car elle définit les exigences et les méthodes de test des gants médicaux à usage unique afin de garantir leur conformité en matière de sécurité et de performance. Le champ d'application de cette norme est spécifiquement orienté vers l'évaluation de la liberté des gants médicaux de présence de trous, ce qui est primordial pour minimiser les risques d'infections croisées et protéger les patients ainsi que le personnel médical. L'un des principaux points forts de cette norme est sa rigueur méthodologique pour le test de résistance et l'évaluation de la qualité des gants médicaux. Les exigences clairement définies permettent aux fabricants de s'assurer que les produits respectent les critères nécessaires à leur usage dans un environnement clinique. De plus, cette norme renforce la confiance des utilisateurs, en garantissant que les gants offrent une barrière efficace contre les agents pathogènes. La pertinence de la norme SIST EN 455-1:2020+A1:2022 ne saurait être sous-estimée, surtout dans le contexte actuel où la sécurité sanitaire occupe une place centrale dans les pratiques médicales. En instaurant des normes strictes pour l'évaluation de la liberté de trous, cette norme contribue à la protection de la santé publique et à l'amélioration continue des pratiques en matière d'hygiène. En conclusion, la norme SIST EN 455-1:2020+A1:2022 est un outil incontournable pour toute organisation impliquée dans la production, la distribution ou l'utilisation de gants médicaux à usage unique, attestant ainsi de son importance cruciale dans le domaine de la santé.
SIST EN 455-1:2020+A1:2022は、使い捨て医療用手袋に関する重要な標準であり、その主な焦点は「穴の自由に関する要求事項と試験方法」にあります。この標準は、医療現場において使用される使い捨て手袋の安全性を確保するために必要な要件を明確に定めています。 この文書の強みは、医療用手袋の製造者や供給者が遵守すべき具体的な試験方法を提供している点です。例えば、使用される材料や製品の特性についてのガイドラインが示されており、これにより製造プロセスの透明性が確保されます。また、標準に基づく試験は、手袋の品質管理において重要な役割を果たし、医療従事者と患者の安全を高める要素となっています。 さらに、SIST EN 455-1:2020+A1:2022は、国際的な医療基準と整合性があり、医療用手袋の品質評価に関する国際的なニーズに応えるものです。この標準は、手袋の使用目的や市場における適合性を考慮し、医療現場での効果的な使用を支援します。 要するに、SIST EN 455-1:2020+A1:2022は、医療用手袋に関連する試験方法と要件を詳細に規定することで、使い捨て手袋の信頼性と安全性を確保するための基盤を提供します。この標準は、医療業界における重要なリソースであり、手袋の性能を正確に評価するための不可欠な指針となっています。
Die Norm SIST EN 455-1:2020+A1:2022 legt die grundlegenden Anforderungen und Testmethoden für medizinische Einmalhandschuhe fest, um die Freiheit von Löchern zu bestimmen. Diese Norm ist von zentraler Bedeutung im medizinischen Bereich, da sie sicherstellt, dass Einmalhandschuhe den notwendigen Schutz bieten und somit die Sicherheit sowohl für medizinisches Personal als auch für Patienten gewährleisten. Ein herausragendes Merkmal dieser Norm ist die detaillierte Beschreibung der Prüfmethoden, die dazu dienen, die Integrität der Handschuhe zu überprüfen. Dies umfasst sowohl die Einsatzmöglichkeiten in verschiedenen medizinischen Umgebungen als auch die Einhaltung strenger Prüfstandards. Die Norm trägt somit nicht nur zur Qualitätssicherung bei, sondern fördert auch das Vertrauen in die Produkte, die im Gesundheitswesen verwendet werden. Die Relevanz dieser Norm ist besonders im Kontext der globalen Gesundheitskrisen zu sehen. Während der COVID-19-Pandemie wurde die Nachfrage nach hochwertigen medizinischen Handschuhen enorm gesteigert, weshalb Standards wie die SIST EN 455-1:2020+A1:2022 essenziell sind, um eine einheitliche Qualität im Markt zu garantieren. Darüber hinaus unterstützt die Norm die Hersteller dabei, ihre Produkte an gesetzliche Anforderungen anzupassen und somit die Marktfähigkeit zu erhöhen. Die Einhaltung der in der Norm festgelegten Kriterien signalisiert sowohl Importeuren als auch Anbietern, dass die Handschuhe geprüfte Sicherheit und Qualität aufweisen. Insgesamt bietet die SIST EN 455-1:2020+A1:2022 eine solide Grundlage für die Herstellung und Prüfung von medizinischen Einmalhandschuhen, was sie zu einer unverzichtbaren Ressource in der Medizinbranche macht. Die Norm fördert nicht nur die Gesundheit und Sicherheit, sondern trägt auch zu einem einheitlichen Standard in der Qualität von medizinischen Produkten bei.
SIST EN 455-1:2020+A1:2022 문서는 일회용 의료장갑의 구멍이 없는지를 확인하기 위한 요구사항과 시험 방법을 규정하고 있습니다. 이 표준은 의료 분야에서 매우 중요한 역할을 수행하며, 환자와 의료 종사자 간의 감염 전파를 최소화하는 데 필수적입니다. 이 표준의 강점 중 하나는 명확한 시험 방법론을 제공한다는 점입니다. 의료장갑의 신뢰성을 보장하기 위해, 구멍의 존재 여부를 정량적으로 평가할 수 있는 대비 방법을 제시하고 있어 사용자들이 신뢰할 수 있는 제품을 선택하는 데 큰 도움이 됩니다. 이는 결과적으로 전체 의료 시스템의 안전성과 효율성을 높이는데 기여합니다. 또한, SIST EN 455-1의 적합성과 중요성은 의료장갑 사용의 필수 요소가 된 감염 예방의 원칙에 뿌리를 두고 있습니다. 장갑의 품질 보증은 감염 통제에 있어서 결정적인 역할을 하며, 의료 기관의 표준 운영 절차(SOP)와도 잘 연계됩니다. 이러한 점에서 이 표준은 일회용 의료장갑의 품질 관리를 강화하고, 모든 사용자를 보호하는 데 중요한 틀을 제공합니다. 결국, SIST EN 455-1:2020+A1:2022 표준은 의료 장갑의 안전성과 효율성을 확보하는 데 핵심적인 기준을 제시하며, 의료 환경에서의 신뢰를 형성하는 데 기여합니다. 따라서 이 표준은 일회용 의료장갑을 사용하는 모든 관련 분야에서 필수적이며, 향후 지속적인 개선과 연구의 기초가 될 것입니다.
The standard EN 455-1:2020+A1:2022 is a critical document in the realm of medical gloves for single use, specifically addressing the requirements and testing methodologies to ensure freedom from holes. Its scope encompasses a significant aspect of healthcare safety, as it provides a framework to evaluate the integrity of medical gloves, which are essential in preventing contamination and infection during medical procedures. One of the strengths of this standard is its detailed approach to the testing methods employed to assess the gloves. By establishing clear requirements, the EN 455-1 ensures that manufacturers adhere to rigorous testing protocols, thereby guaranteeing that the gloves meet the necessary safety and quality standards. The thorough evaluation methods outlined enhance the reliability of the gloves used in various medical settings, thereby reinforcing patient safety. Furthermore, the standard's relevance cannot be understated. In an environment where healthcare-associated infections are a critical concern, the ability to verify the freedom from holes in medical gloves is paramount. This document not only aids manufacturers in producing safe medical devices but also instills confidence among healthcare professionals and patients regarding the protective measures being utilized. The integration of updates in the 2022 amendment indicates an ongoing commitment to improving safety standards in the medical field, reflecting the dynamic nature of health care demands. Overall, EN 455-1:2020+A1:2022 serves as an indispensable guide for ensuring that medical gloves are rigorously tested for holes, providing a necessary benchmark for safety and efficacy in healthcare environments.
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