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CEN

EN ISO 18113-5:2009

(Main)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009)

Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung fest.
Dieser Teil von ISO 18113 gilt auch für Geräte und Ausrüstungen, die für den Gebrauch von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung vorgesehen sind.
Dieser Teil von ISO 18113 kann auch auf Zubehör angewendet werden.
Der vorliegende Teil von ISO 18113 gilt nicht für:
a)   Anweisungen für die Geräteinstandhaltung oder  reparatur;
b)   IVD Reagenzien, einschließlich Kalibriermittel und Kontrollmaterialien zur Kontrolle des Reagenz; oder
c)   IVD Instrumente zum Gebrauch durch Fachpersonal.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009)

L'ISO 18113-5:2009 spécifie les exigences relatives aux informations fournies par le fabricant d'instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 s'applique aussi aux appareillages et aux équipements destinés à être utilisés avec les instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 peut aussi s'appliquer aux accessoires, le cas échéant.

Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 5. del: Diagnostični instrumenti in vitro za samopreskušanje (ISO 18113-5:2009)

Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih instrumentov in vitro za samopreskušanje. Ta del ISO 18113 velja tudi za aparate in opremo, ki se uporabljajo z diagnostičnimi instrumenti in vitro za samopreskušanje. Ta del ISO 18113 lahko velja tudi za dodatno opremo. Ta del ISO 18113 ne velja za a) navodila za servisiranje ali popravilo instrumentov, b) diagnostične reagente in vitro, vključno s kalibratorji in kontrolnimi materiali, ki se uporabljajo pri nadzoru reagenta, c) diagnostične instrumente in vitro za poklicno uporabo.

General Information

Status
Withdrawn
Publication Date
14-Dec-2009
Withdrawal Date
18-Oct-2011
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140 - In vitro diagnostic systems
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
19-Oct-2011
Completion Date
19-Oct-2011
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 ISO 18113-5:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Relations

Replaces
EN 592:2002 - Instructions for use for in vitro diagnostic instruments for self-testing
Effective Date
22-Dec-2008
Replaced By
EN ISO 18113-5:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
Effective Date
15-Oct-2011

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009)Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN ISO 18113-5:2009SIST EN ISO 18113-5:2010en01-marec-2010SIST EN ISO 18113-5:2010SLOVENSKI
STANDARDSIST EN 592:20021DGRPHãþD



SIST EN ISO 18113-5:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18113-5
December 2009 ICS 11.100.10 Supersedes EN 592:2002English Version
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009) This European Standard was approved by CEN on 18 November 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18113-5:2009: ESIST EN ISO 18113-5:2010



EN ISO 18113-5:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” .4 SIST EN ISO 18113-5:2010



EN ISO 18113-5:2009 (E) 3 Foreword This document (EN ISO 18113-5:2009) has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2010, and conflicting national standards shall be withdrawn at the latest by December 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 592:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18113-5:2009 has been approved by CEN as a EN ISO 18113-5:2009 witho
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