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 Untersuchungs-/Behandlungshandschuhe) 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

General Information

Status
Published
Public Enquiry End Date
29-Sep-2013
Publication Date
17-Jun-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
15-May-2015
Due Date
20-Jul-2015
Completion Date
18-Jun-2015

RELATIONS

Buy Standard

Standard
SIST EN 455-2:2015
English language
11 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

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 455-2:2015SIST EN 455-2:2015en,fr,de01-julij-2015SIST EN 455-2:2015SLOVENSKI

STANDARDSIST EN 455-2:2010+A2:20131DGRPHãþD
SIST EN 455-2:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2
April 2015 ICS 11.140 Supersedes EN 455-2:2009+A2:2013English Version

Medical gloves for single use - Part 2: Requirements and testing for physical properties

Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés physiques

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften This European Standard was approved by CEN on 24 January 2015.

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
CEN-CENELEC Management Centre:
Avenue Marnix 17,

B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2015 ESIST EN 455-2:2015

EN 455-2:2015 (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 ..................................................................................................................................................7 5.1 General ....................................................................................................................................................7 5.2 Force at break ........................................................................................................................................7 5.3 Force at break after challenge testing .................................................................................................9 6 Test report ........................................................................................................................................... 10 7 Labelling .............................................................................................................................................. 10 Annex ZA (informative)

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices ....................................... 11

SIST EN 455-2:2015

EN 455-2:2015 (E) 3 Foreword This document (EN 455-2:2015) 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 October 2015 and conflicting national standards shall be withdrawn at the latest by October 2015. 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+A2:2013. 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. With respect to EN 455-2:2009+A2:2013 the following changes are: a) normative references revised; b) new Clause 7 "labelling" introduced; c) exception for nitrile in Table 3 for median values of force of break deleted; d) Annex ZA updated. 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, 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 the United Kingdom. SIST EN 455-2:2015

EN 455-2:2015 (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 European 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 documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 455-4:2009, Medical gloves for single use — Part 4: Requirements and testing for shelf life determination EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices EN ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied —Part 1: General requirements (ISO 15223-1:2012) ISO 188:2007, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests ISO 23529:2010, 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 lying 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

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.