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- Withdrawn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
- 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
Relations
- Effective Date
- 24-Apr-2013
- Effective Date
- 28-Jan-2026
- Referred By
EN ISO 2495:2000 - Iron blue pigments - Specifications and methods of test (ISO 2495:1995) - Effective Date
- 28-Jan-2026
- Referred By
EN ISO 473:2020 - Lithopone pigments - General requirements and methods of testing (ISO 473:2019) - Effective Date
- 28-Jan-2026
Get Certified
Connect with accredited certification bodies for this standard

BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.

TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 12376:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology". This standard covers: 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.
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.
EN 12376:1999 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12376:1999 has the following relationships with other standards: It is inter standard links to EN ISO 19001:2013, EN ISO 1248:2008, EN ISO 2495:2000, EN ISO 473:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12376:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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
...




Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...