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CEN

EN ISO 18113-5:2011

(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
Published
Publication Date
18-Oct-2011
Withdrawal Date
30-Oct-2014
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
6060 - Definitive text made available (DAV) - Publishing
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 18113-5:2012 - 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 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)
Effective Date
15-Oct-2011
Revised
FprEN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
Effective Date
19-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18113-5:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-5:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]QDþHYDQMH 
GHO'LDJQRVWLþQLLQVWUXPHQWLLQYLWUR]DVDPRSUHVNXãDQMH ,62
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-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)
Ta slovenski standard je istoveten z: EN ISO 18113-5:2011
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 18113-5:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 18113-5:2012

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SIST EN ISO 18113-5:2012


EUROPEAN STANDARD
EN ISO 18113-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-5:2009
English 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 In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 5: Instruments durch den Hersteller - Teil 5: Geräte für in-vitro-
de diagnostic in vitro pour auto-tests (ISO 18113-5:2009) diagnostische Untersuchungen zur Eigenanwendung (ISO
18113-5:2009)
This European Standard was approved by CEN on 20 September 2011.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-5:2011: E
worldwide for CEN national Members.

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

SIST EN ISO 18113-5:2012
EN ISO 18113-5:2011 (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 18113-5:2012
EN ISO 18113-5:2011 (E)
Foreword
This document (EN ISO 18113-5:2011) 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by October 2014.
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 ISO 18113-5:2009.
This new edition contains a revised Annex ZA.
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.
Fo
...

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