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CEN

EN ISO 18113-3:2009

(Main)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009)

Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in vitro diagnostische Untersuchungen zum Gebrauch durch Fachpersonal fest.
Dieser Teil von ISO 18113 gilt auch für Ausrüstungen und Materialien, die für den Gebrauch von Geräten für in vitro diagnostische Untersuchungen zum Gebrauch durch Fachpersonal 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;
c)   IVD Instrumente zur Eigenanwendung.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO 18113-3:2009)

L'ISO 18113-3:2009 spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de DIV pour usage professionnel.
L'ISO 18113-3:2009 s'applique aussi aux appareillages et équipements destinés à être utilisés avec les instruments de DIV pour usage professionnel.
L'ISO 18113-3:2009 peut aussi s'appliquer aux accessoires, le cas échéant.

Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 3. del: Diagnostični instrumenti in vitro za poklicno uporabo (ISO 18113-3:2009)

Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih instrumentov in vitro za poklicno uporabo. Ta del ISO 18113 velja tudi za aparate in opremo, ki se uporabljajo z diagnostičnimi instrumenti in vitro za poklicno uporabo. Ta del ISO 18113 lahko velja tudi za dodatno opremo.

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
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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 18113-3:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

Relations

Replaces
EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use
Effective Date
19-Dec-2009
Replaced By
EN ISO 18113-3:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
Effective Date
24-Oct-2011

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18113-3:2010
01-marec-2010
1DGRPHãþD
SIST EN 591:2002
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]QDþHYDQMH 
GHO'LDJQRVWLþQLLQVWUXPHQWLLQYLWUR]DSRNOLFQRXSRUDER ,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3:
Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal
(ISO 18113-3:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO
18113-3:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-3:2009
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 18113-3:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 18113-3:2010

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SIST EN ISO 18113-3:2010


EUROPEAN STANDARD
EN ISO 18113-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2009
ICS 11.100.10 Supersedes EN 591:2001
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 3: In vitro diagnostic instruments
for professional use (ISO 18113-3:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 3: Instruments durch den Hersteller - Teil 3: Geräte für in-vitro-
de diagnostic in vitro à usage professionnel (ISO 18113- diagnostische Untersuchungen zum Gebrauch durch
3:2009) Fachpersonal (ISO 18113-3:2009)
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 Ref. No. EN ISO 18113-3:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 18113-3:2010
EN ISO 18113-3:2009 (E)
Contents Page
Foreword .3
Annex 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

2

---------------------- Page: 4 ----------------------

SIST EN ISO 18113-3:2010
EN ISO 18113-3:2009 (E)
Foreword
This document (EN ISO 18113-3:2009) 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 591:2001.
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 informati
...

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