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CEN

EN 12376:1999

(Main)

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

This European standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers, and vendors of dyes, stains, chromogenic reagents, and other reagents used for staining in biology. The requirements for information supplied by the manufacturer specified in this European standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien für biologische Färbungen

Diese Europäische Norm legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für biologische Färbungen fest. Sie gilt für die Hersteller, Lieferanten und Vertreiber von Farbstoffen, Farbstofflösungen, farbgebenden Reagenzien und anderen für biologische Färbungen verwendeten Reagenzien. Die in dieser Europäischen Norm aufgeführten Anforderungen an die vom Hersteller bereitgestellten Informationen sind Voraussetzung für das Erzielen vergleichbarer und reproduzierbarer Ergebnisse in allen Bereichen biologischer Färbungen.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant de réactifs de coloration de diagnostic in vitro utilisés en biologie

La présente norme européenne spécifie des exigences relatives aux informations fournies par le fabricant et applicables aux colorants utilisés en biologie. Elle s'adresse aux fabricants, fournisseurs et distributeurs de teintures, colorants, réactifs chromogènes et autres réactifs de coloration utilisés en biologie. Les exigences relatives aux informations fournies par le fabricant et spécifiées dans la présente norme européenne constituent une condition préalable à l'obtention de résultats comparables et reproductibles dans tous les domaines des colorations biologiques.

Diagnostični medicinski pripomočki in vitro – Informacije, ki jih priskrbi proizvajalec diagnostičnih reagentov za barvanje in vitro v biologiji

General Information

Status
Withdrawn
Publication Date
19-Jan-1999
Withdrawal Date
19-Mar-2013
ICS
11.100 - Laboratory medicine
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 6 - Staining in biology
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
20-Mar-2013
Completion Date
20-Mar-2013
Ref Project
SIST EN 12376:2000 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Relations

Replaced By
EN ISO 19001:2013 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
Effective Date
24-Apr-2013

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.JLMLIn-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien für biologische FärbungenDispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant de réactifs de coloration de diagnostic in vitro utilisés en biologieIn vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology11.100.10In vitro diagnostic test systemsI
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