EN 455-2:2009+A2:2013

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 Hand-schuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kontamination für Patient und Anwender gewähr-leistet 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 (z dopolnili do vključno A2)

Ta evropski standard 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 standard 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

• Status: Withdrawn
• Publication Date: 05-Feb-2013
• Withdrawal Date: 28-Apr-2015
• 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
• Completion Date: 29-Apr-2015
• 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+A2:2013 - Medical gloves for single use - Part 2: Requirements and testing for physical properties

Relations

• Merged From: EN 455-2:2009+A1:2011 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 18-Jan-2023
• Replaced By: EN 455-2:2015 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 06-May-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische 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 455-2:2009+A2:2013SIST EN 455-2:2010+A2:2013en,fr,de01-maj-2013SIST EN 455-2:2010+A2:2013SLOVENSKI
STANDARDSIST EN 455-2:2010+A1:20111DGRPHãþD



SIST EN 455-2:2010+A2:2013



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2:2009+A2
February 2013 ICS 11.140 Supersedes EN 455-2:2009+A1:2011
English 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 and includes Amendment 1 approved by CEN on 3 January 2011 and Amendment 2 approved by CEN on 8 January 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2009+A2:2013: E SIST EN 455-2:2010+A2:2013



EN 455-2:2009+A2:2013 (E) 2 Contents Page Foreword . 3 1 Scope . 4 2 Normative references . 4 3 Terms and definitions . 4 4 Dimensions . 5 4.1 General . 5 4.2 Length . 5 4.3 Width . 5 5 Strength . 6 5.1 General . 6 5.2 Force at break . 6 5.3 Force at break after challenge testing . 8 6 Test report . 8 Annex ZA (informative)
#Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices$ . 11
SIST EN 455-2:2010+A2:2013



EN 455-2:2009+A2:2013 (E) 3 Foreword This document (EN 455-2:2009+A2:2013) has been prepared by Technical Committee CEN
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