|
STANDARDSIST EN 455-3:20071DGRPHãþD
SIST EN 455-3:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-3
April 2015 ICS 11.140 Supersedes EN 455-3:2006English Version
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung 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 455-3:2015 ESIST EN 455-3:2015
EN 455-3:2015 (E) 2 Contents Page
Foreword .3 Introduction .5 1 Scope .6 2 Normative references .6 3 Terms and definitions .6 4 Requirements .7 4.1 General .7 4.2 Chemicals .7 4.3 Endotoxins .8 4.4 Powder-free gloves .8 4.5 Proteins, leachable .8 4.6 Labelling .8 5 Test methods .9 5.1 Endotoxins .9 5.2 Powder .9 5.
...