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CEN

EN 455-3:1999

(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 glove packaging and the disclosure of information relevant to the test methods used. It also contains a review of immunological test methods for the determination of, leachable proteinds and allergens.

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

Dieser Teil der EN 455 legt Anforderungen fu(r die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er entha(lt die Anforderung fu(r die Kennzeichnung, die Handschuhverpackung und die Bereithaltung von Informationen u(ber die angewendeten Pru(fmethoden. Er entha(lt außerdem eine Zusammenfassung von immunologischen Methoden zur Bestimmung von lo(slichen Proteinen und Allergenen.

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 ` usage unique. Elle mentionne les exigences d'étiquetage et d'emballage des gants ainsi que d'obtention des informations intéressant les méthodes d'essai utilisées. Elle contient également un résumé des méthodes d'essai immunologiques destinées au dosage des protéines extractibles et des allergènes.

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

General Information

Status
Withdrawn
Publication Date
07-Dec-1999
Withdrawal Date
05-Dec-2006
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
Start Date
06-Dec-2006
Completion Date
06-Dec-2006
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 455-3:2000 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

Replaced By
EN 455-3:2006 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
22-Dec-2008

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske rokavice za enkratno uporabo - 3.del: Zahteve in preskusi za biološko ovrednotenjeMedizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfungen 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 455-3:1999SIST EN 455-3:2000en01-julij-2000SIST EN 455-3:2000SLOVENSKI
STANDARD



SIST EN 455-3:2000



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