EN 376:2002

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

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

Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung

Diese Norm legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen (einschließlich Reagenzprodukte, Kalibriermaterialien, Kontrollmaterialien und Kits), nachstehend IVD-Reagenzien genannt, für die Eigenanwendung fest.
ANMERKUNG   Diese Norm kann auch für Zubehör angewendet werden.

Informations fournies par le fabricant de réactifs pour le diagnostic in vitro pour l'utilisation comme auto-test

La présente Norme européenne spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro pour auto-test, y compris les produits réactifs, les calibrateurs, les matériaux de contrôle et les trousses, lesquels sont désignés par le terme réactifs DIV dans la suite du présent document.
NOTE   La présente norme peut également être appliquée aux accessoires.

Informacije proizvajalca o diagnostičnih reagentih in vitro za samopreskušanje

General Information

• Status: Withdrawn
• Publication Date: 12-Feb-2002
• Withdrawal Date: 14-Dec-2009
• 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 376:2002 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

Relations

• Replaces: EN 376:1992 - In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for self-testing
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 18113-4:2009 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Information supplied by the manufacturer with in vitro diagnostic reagents for self-testingPRSUHVNXãDQMHInformations fournies par le fabricant de réactifs pour le diagnostic in vitro pour l'utilisation comme auto-testBereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zur EigenanwendungTa slovenski standard je istoveten z:EN 376:2002SIST EN 376:2002en11.100.10In vitro diagnostic test systemsICS:SIST EN 376:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN 376:200201-november-2002







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 376February 2002ICS 11.100Supersedes EN 376:1992English versionInformation supplied by the manufacturer with in vitro diagnosticreagents for self-testingInformations fournies par le fabricant de réactifs pour lediagnostic in vitro pour l'utilisation comme auto-testBereitstellung von Informationen durch den Hersteller vonReagenzien für in-vitro-diagnostische Untersuchungen zurEigenanwendungThis European Standard was approved by CEN on 20 December 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 376:2002 E



EN 376:2002 (E)2ContentspageForeword31Scope32Normative references33Terms and definitions34Requirements for labels64.1Outer container64.2Immediate container85Requirements for instructions for use9Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or otherprovisions of EU Directives13Bibliography15



EN 376:2002 (E)3ForewordThis European Standard has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medicaldevices", the secretariat of which is held by DIN.The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation.This European Standard shall be given the status of a national standard, either by publication of an identical textor by endorsement, at the latest by August 2002, and conflicting national standards shall be withdrawn at thelatest by August 2002.This European Standard supersedes EN 376:1992.This European Standard has been prepared under a mandate given to CEN by the European Commission andthe European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.1ScopeThis European Standard specifies the requirements for the information supplied by the manufacturer of in vitrodiagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, whichhereafter are called IVD reagents.NOTE
This standard can also be applied to accessories.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest editions of thepublication referred to applies (including amendments).ISO 1000, SI units and recommendations for the use of their multiples and of certain other units.3Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1active ingredientconstituent that participates in the reactio
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