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EN 455-3:2006

(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 der 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 preskusi za biološko ovrednotenje

General Information

Status
Withdrawn
Publication Date
05-Dec-2006
Withdrawal Date
31-Mar-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
01-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 455-3:2007 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

Replaces
EN 455-3:1999 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
22-Dec-2008
Replaced By
EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
08-Apr-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 455-3:2007
01-marec-2007
1DGRPHãþD
SIST EN 455-3:2000
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskusi za biološko
ovrednotenje
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3: Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2006
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-3:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 455-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2006
ICS 11.140 Supersedes EN 455-3:1999
English Version
Medical gloves for single use - Part 3: Requirements and testing
for biological evaluation
Gants médicaux non réutilisables - Partie 3: Exigences et Medizinische Handschuhe zum einmaligen Gebrauch - Teil
essais pour évaluation biologique 3: Anforderungen und Prüfung für die biologische
Bewertung
This European Standard was approved by CEN on 13 October 2006.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2006: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN 455-3:2006 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Requirements.6
5 Test methods.8
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 measurement of natural rubber latex
allergens .20
Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography
(HPLC).27
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices.36

2

---------------------- Page: 3 ----------------------

EN 455-3:2006 (E)
Foreword
This document (EN 455-3:2006) has
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