SIST EN 455-2:2010+A1:2011

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 singleuse 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

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 zagotavljajo 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: 16-Jun-2011
• Withdrawal Date: 17-Apr-2013
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 12-Apr-2013
• Due Date: 05-May-2013
• Completion Date: 18-Apr-2013
• 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: EN 455-2:2009+A1:2011 - Medical gloves for single use - Part 2: Requirements and testing for physical properties

Relations

• Consolidated By: SIST EN 455-2:2010+A2:2013 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 455-2:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 01-Jul-2011
• Consolidates: SIST EN 455-2:2010/kFprA1:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 01-Jul-2011
• Consolidated By: SIST EN 455-2:2010+A2:2013 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 455-2:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 455-2:2010/kFprA1:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 18-Jan-2023
• Replaced By: SIST EN 455-2:2010+A2:2013 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 01-May-2013
• Consolidates: SIST EN 455-2:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 455-2:2010/kFprA1:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 19-Jan-2023

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 455-2:2009+A1:2011SIST EN 455-2:2010+A1:2011en,fr,de01-julij-2011SIST EN 455-2:2010+A1:2011SLOVENSKI
STANDARD



SIST EN 455-2:2010+A1:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2:2009+A1
February 2011 ICS 11.140 Supersedes EN 455-2:2009English 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.
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, 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 © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2009+A1:2011: ESIST EN 455-2:2010+A1:2011



EN 455-2:2009+A1:2011 (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 . 86 Test report . 8Annex 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+A1:2011



EN 455-2:2009+A1:2011 (E) 3 Foreword This document (EN 455-2:2009+A1:2011) 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 2011, and conflicting national standards shall be withdrawn at the latest by August 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes !EN 455-2:2009". This document includes Amendment 1, approved by CEN on 2011-01-03. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ". This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. 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 According to the CEN/CENELEC Internal Regulations, the national standards organizations 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
SIST EN 455-2:2010+A1:2011



EN 455-2:2009+A1:2011 (E) 4 1 Scope 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. 2 Normative references The following referenced documents are indispensable for the application 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. ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests ISO 23529:2004, Rubber — General procedures for preparing and conditioning test pieces for physical test methods 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 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 laying flat, and intended for use in invasive surgery 3.3 examination gloves procedure gloves sterile or non-sterile medical gloves, which may or may not 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
[EN 455-4:2009] SIST EN 455-2:2010+A1:2011



EN 455-2:2009+A1:2011 (E) 5 4 Dimensions 4.1 General When measured as described in 4.2 and 4.3 taking 13 sampl
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