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- Withdrawn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
- 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 - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 19-Dec-2009
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 375:2001 is a standard published by the European Committee for Standardization (CEN). Its full title is "Information supplied by the manufacturer with in vitro diagnostic reagents for professional use". This standard covers: 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.
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.
EN 375:2001 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 375:2001 has the following relationships with other standards: It is inter standard links to EN 375:1992, EN ISO 18113-2:2009, EN 14136:2004, EN ISO 17511:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 375:2001 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 375:2001 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.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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