EN 455-1:2020
(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
General Information
Relations
Frequently Asked Questions
EN 455-1:2020 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 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 has the following relationships with other standards: It is inter standard links to EN 455-1:2000, EN 455-1:2020+A1:2022, EN 455-1:2020/prA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-1:2020 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; 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.
You can purchase EN 455-1:2020 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-september-2020
Nadomešča:
SIST EN 455-1:2001
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medizinische Handschuhe zum einmaligen Gebrauch - 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
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 455-1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2000
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.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020 E
worldwide for CEN national Members.
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) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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 455-1:2000.
Compared to the previous edition the following main changes have been introduced:
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 standards
...
SIST EN 455-1:2020は、医療用使い捨て手袋に関する重要な標準であり、その主要な焦点は「穴のない状態」に関する要求事項と試験方法を明確に定義しています。この標準は、医療現場での安全性を確保するために不可欠であり、高い信頼性を兼ね備えています。 この文書の強みの一つは、明確な要求仕様が設定されている点です。医療用使い捨て手袋は、感染症のリスクを低減するために重要であり、この標準は用具の性能評価に必要な基準を提供します。具体的には、穴の検出に関する試験方法が詳細に記述されており、製造者はその基準を満たすことを求められます。これにより、医療提供者は安全に使用できる手袋を選択でき、患者や医療従事者の両方の安全が守られます。 さらに、SIST EN 455-1:2020は、規制や業界の要件に準拠しており、医療機関や手袋メーカーがこの標準に基づいて製品を開発・検証することで、法令遵守を確実にする助けとなります。このことは、医療業界全体の透明性を高め、信頼性を向上させる要因となります。 このように、SIST EN 455-1:2020は、医療用使い捨て手袋の品質と安全性を確保するための基盤を提供しており、その影響力は医療環境での使用において極めて重要です。標準を遵守することにより、業界全体がより高い安全基準を維持し、患者ケアの向上に寄与することが期待されます。
SIST EN 455-1:2020은 단일 사용을 위한 의료 장갑에 대한 요구 사항과 시험 방법을 규정하여 구멍의 자유를 확인하는 데 중점을 두고 있습니다. 이 문서는 의료 장갑의 안전성을 보장하기 위한 필수 표준으로, 다양한 분야에서 사용되는 의료 장비의 신뢰성을 높이는 데 기여합니다. 이 표준의 주요 강점 중 하나는 의료 장갑의 품질을 보장하기 위해 과학적이고 체계적인 시험 방법을 제시한다는 점입니다. 이러한 방법을 통해 제조업체는 제품의 결함 여부를 명확하게 확인할 수 있으며, 이는 환자의 안전을 크게 향상시킵니다. 또한, EN 455-1은 국제적으로 통용되는 기준이라는 점에서, 글로벌 시장에서의 경쟁력을 유지하는 데 중요한 역할을 합니다. EN 455-1:2020의 범위는 단일 사용 의료 장갑에 국한되지만, 이는 의료 환경에서 필수적인 요소입니다. 의료 장갑의 구멍 여부를 확인하는 과정은 감염 예방 및 환자의 생명 보호에 직접적으로 연결되므로, 이 표준이 가지는 중요성은 그 자체로 매우 크다고 할 수 있습니다. 마지막으로, SIST EN 455-1:2020은 의료 산업에서 법적 요구 사항을 충족하는 데 도움을 주는 자료로, 제조업체가 의무적으로 따라야 하는 기준을 제시합니다. 이러한 점에서 이 표준은 의료 기기의 품질 및 안전성을 확보하는 데 필수적이라는 점에서 높은 관련성을 가지고 있습니다.
The EN 455-1:2020 standard serves a critical role in ensuring safety and reliability in the use of medical gloves for single use. The document specifically outlines requirements and the testing method to assess freedom from holes in these gloves, which is an essential aspect of their performance and safety. One of the primary strengths of the EN 455-1:2020 standard is its comprehensive approach towards quality assurance in the production of medical gloves. By establishing stringent criteria and testing protocols, the standard ensures that gloves meet the necessary safety benchmarks before reaching healthcare providers. This is particularly important in medical environments where contamination could lead to serious health risks. Additionally, the testing methods specified in this standard create a standardized procedure for manufacturers, promoting consistency and reliability across the industry. This helps to enhance trust among users-medical professionals who rely on the efficacy of these gloves during surgical and diagnostic procedures. The relevance of EN 455-1:2020 cannot be overstated, especially in the context of increasing global health challenges. The rise in healthcare services and the heightened focus on infection control measures accentuate the need for standards that ensure the integrity of protective equipment such as medical gloves. By validating that these gloves are free from holes, the standard plays an essential part in safeguarding patient and healthcare worker safety. In summary, the EN 455-1:2020 standard is a pivotal document that encapsulates critical requirements and rigorous testing protocols for medical gloves for single use. Its focused scope, robust testing methods, and significant industry relevance collectively contribute to enhanced health safety standards, making it a key reference in medical glove production and usage.
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