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CEN

EN 455-3:2015

(Main)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung

Dieser Teil von EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er enthält Anforderungen für die Kennzeichnung und die Angabe von Informationen über die angewendeten Prüfmethoden.

Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique

La présente partie de l’EN 455 spécifie les exigences permettant d’évaluer la sécurité biologique des gants médicaux à usage unique. Elle mentionne les exigences d’étiquetage des gants et de diffusion des informations concernant les méthodes d’essai utilisées.

Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za biološko ovrednotenje

General Information

Status
Withdrawn
Publication Date
31-Mar-2015
Withdrawal Date
28-Nov-2023
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
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 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

Replaces
EN 455-3:2006 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
08-Apr-2015
Replaced By
EN 455-3:2023 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
18-Dec-2019
Amended By
EN 455-3:2015/prA1 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
18-May-2016

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za biološko ovrednotenjeMedizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische BewertungGants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologiqueMedical gloves for single use - Part 3: Requirements and testing for biological evaluation11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 455-3:2015SIST EN 455-3:2015en,fr,de01-junij-2015SIST EN 455-3:2015SLOVENSKI
STANDARDSIST EN 455-3:20071DGRPHãþD

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

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 5.3 Proteins, leachable .9 6 Test report .9 Annex A (normative)
Method for the determination of aqueous extractable proteins in natural rubber gloves using the modified Lowry assay . 10 Annex B (informative)
Immunological methods for the measurements of natural rubber latex allergens . 20 Annex C (informative)
Amino acid analysis (AAA) by high pressure liquid chromatography (HPLC) . 26 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices . 34
...

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