EN 375:2001

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• Status: Withdrawn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)
• ICS: 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
• Directive: 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

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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