EN 455-2:2009

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 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 Handschuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungshandschuhe) 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 : Propriétés physiques : Exigences et essais

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

Ta evropski standard določa zahteve in podaja preskusne metode za ugotavljanje fizikalnih lastnosti medicinskih rokavic za enkratno uporabo (tj. kirurških rokavic ter rokavic za preglede/postopke), ki zagotavljajo, da rokavice omogočajo in med uporabo ohranjajo primerno raven zaščite bolnika in uporabnika pred navzkrižno okužbo. Ta standard ne določa velikosti lota.  Upoštevati je treba težave, ki so lahko povezane z dostavo in nadzorom zelo velikih lotov. Največja priporočena velikost posameznega lota za proizvodnjo je 500.000.

General Information

• Status: Withdrawn
• Publication Date: 03-Nov-2009
• Withdrawal Date: 15-Feb-2011
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 16-Feb-2011
• Completion Date: 16-Feb-2011
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 455-2:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties

Relations

• Replaces: EN 455-2:2000 - Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)
• Effective Date: 07-Nov-2009
• Merged Into: EN 455-2:2009+A1:2011 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 11-Dec-2010
• Amended By: EN 455-2:2009/FprA1 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 12-Jun-2010
• Revised: EN 455-2:2015 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 08-Jun-2010

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 455-2:2009SIST EN 455-2:2010en,fr,de01-januar-2010SIST EN 455-2:2010SLOVENSKI
STANDARDSIST EN 455-2:20011DGRPHãþD



SIST EN 455-2:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2
November 2009 ICS 11.140 Supersedes EN 455-2:2000English Version
Medical gloves for single use -Part 2: Requirements and testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Propriétés physiques: exigences et essais
Medizinische Handschuhe zum einmaligen Gebrauch -Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften This European Standard was approved by CEN on 3 October 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2009: ESIST EN 455-2:2010



EN 455-2:2009 (E) 2 Contents Page Foreword . 31 Scope . 42 Normative references . 43 Terms and definitions . 44 Dimensions . 54.1 General. 54.2 Length . 54.3 Width . 55 Strength . 65.1 General. 65.2 Force at break . 65.3 Force at break after challenge testing . 76 Test Report . 8Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 10 SIST EN 455-2:2010



EN 455-2:2009 (E) 3 Foreword This document (EN 455-2:2009) 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 M
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