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CEN

EN 375:2001

(Main)

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.

Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal

Diese Norm führt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von In-vitro-Diagnostika-Reagenzien einschließlich Reagenprodukte, Kalibriermaterialien, Kontrollmaterialien und Kits, nachstehend Reagenzien genannt, für den Gebrauch durch Fachpersonal auf. Anmerkung: Diese Norm kann auch für Zubehör angewendet werden.

Informations fournies par le fabricant avec les réactifs de diagnostic in vitro pour usage professionnel

La présente Norme Européenne spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro incluant les supports de réaction, les calibrateurs, les matériaux de contrôle et les trousses pour usage professionnel, qui sont appelés ci-dessous réactifs. Note: La présente norme peut également s'appliquer aux accessoires.

Informacije proizvajalca o diagnostičnih reagentih in vitro za poklicno uporabo

General Information

Status
Withdrawn
Publication Date
23-Jan-2001
Withdrawal Date
14-Dec-2009
ICS
01.040.11 - Health care technology (Vocabularies)
11.100 - Laboratory medicine
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 1 - Labelling and performance evaluation
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Dec-2009
Completion Date
15-Dec-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
Ref Project
SIST EN 375:2001 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Relations

Replaces
EN 375:1992 - In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for professional use
Effective Date
22-Dec-2008
Replaced By
EN ISO 18113-2:2009 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Effective Date
19-Dec-2009

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zum Gebrauch durch FachpersonalInformations fournies par le fabricant avec les réactifs de diagnostic in vitro pour usage professionnelInformation supplied by the manufacturer with in vitro diagnostic reagents for professional use11.100.1
...

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