EN ISO 18113-2:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-2:2009)

Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für in vitro diagnostische Untersuchungen für den Gebrauch durch Fachpersonal fest.
Dieser Teil von ISO 18113 gilt auch für die Bereitstellung von Informationen durch den Hersteller von Kalibriermitteln und Kontrollmaterialien, die für den Gebrauch mit In vitro Diagnostika durch Fachpersonal vorgesehen sind.
Sofern zutreffend, kann dieser Teil von ISO 18113 auch auf Zubehör angewendet werden.
Dieser Teil von ISO 18113 gilt für Etiketten für die äußeren und Primärbehälter sowie die Gebrauchs-anweisung.
Der vorliegende Teil von ISO 18113 gilt nicht für:
a)   IVD Geräte oder Ausrüstungen,
b)   IVD Reagenzien zur Eigenanwendung.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2: Réactifs de diagnostic in vitro à usage professionnel (ISO 18113-2:2009)

L'ISO 18113-2:2009 spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de DIV pour usage professionnel.
L'ISO 18113-2:2009 s'applique aussi aux informations fournies par le fabricant avec les étalons et les matériaux de contrôle destinés à être utilisés avec des dispositifs médicaux de DIV pour usage professionnel.
L'ISO 18113-2:2009 peut aussi s'appliquer aux accessoires, le cas échéant.
L'ISO 18113-2:2009 s'applique aux étiquettes apposées sur l'emballage externe et le contenant primaire et aux notices d'utilisation.

Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 2. del: Diagnostični reagenti in vitro za poklicno uporabo (ISO 18113-2:2009)

Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih reagentov in vitro za poklicno uporabo. Ta del ISO 18113 velja tudi za informacije proizvajalca glede kalibratorjev in kontrolnih materialov, ki se uporabljajo z diagnostičnimi preskusnimi sistemi in vitro za poklicno uporabo. Ta del ISO 18113 lahko velja tudi za dodatno opremo. Ta del ISO 18113 velja za oznake na zunanjih in neposrednih embalažah ter za navodila za uporabo. Ta del ISO 18113 ne velja za a) diagnostične instrumente ali opremo in vitro, b) diagnostične reagente in vitro za samopreskušanje.

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
• 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 18113-2:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Relations

• Replaces: EN 375:2001 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
• Effective Date: 19-Dec-2009
• Replaced By: EN ISO 18113-2:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2010
1DGRPHãþD
SIST EN 375:2001
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFDR]QDþHYDQMH
GHO'LDJQRVWLþQLUHDJHQWLLQYLWUR]DSRNOLFQRXSRUDER,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-
vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-
2:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 2: Réactifs de diagnostic in vitro à usage professionnel (ISO 18113-
2:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-2:2009
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 18113-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2009
ICS 11.100.10 Supersedes EN 375:2001
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 2: In vitro diagnostic reagents for
professional use (ISO 18113-2:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 2: Réactifs de durch den Hersteller - Teil 2: In-vitro-diagnostische
diagnostic in vitro à usage professionnel (ISO 18113- Reagenzien für den Gebrauch durch Fachpersonal (ISO
2:2009) 18113-2:2009)
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 18113-2:2009: E
worldwide for CEN national Members.

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

Foreword
This document (EN ISO 18113-2:2009) 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 will supersede EN 375:2001.
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 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 18113-2:2009 has been approved by CEN as a EN ISO 18113-2:2009 without any
modification.
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”
This European Standard has been prepared under a mandate given to CEN by the European Commission to
provide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “in
vitro Diagnostic Medical Devices”.

Once this European Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA confers, within the limits of the scope of this International Standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA — Correspondence between this European Standard and European Directive 98/79/EC

Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/Notes
Directive 98/79/EC
International Standard
4.1 B.8.1, B.8.2
See Note 1.
5.1 B.8.4 (a)
5.2.1 B.8.4 (b)
5.2.2 B.8.4 (d), B.8.6
5.3 B.8.4 (b)
5.4 B.8.5
5.5 B.8.4 (g)
5.6 B.8.4.(h)
5.7 B.8.4 (e)
5.8 B.8.3, B.8.4 (j) See Note 2.
6.1 B.8.1, B.8.2
6.2 B.8.4 (a) See Note 1.
6.3.1 B.8.4 (b)
6.3.2 B.8.4 (d), B.8.6
6.4 B.8.4 (b)
Table ZA (continued)
Clause(s)/subclause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 98/79/EC
6.5 B.8.4 (g)
6.6 B.8.4 (h)
6.7 B.8.4 (e)
6.8 B.8.3, B.8.4 (j) See Note 2.
7.1 B.8.7 (a) See Notes 1 and 3.
7.2 B.8.7 (a) See Note 3.
7.3 B.8.5
7.4 B.8.7 (h)
7.5 B.8.7 (k)
7.6 B.8.7 (b)
7.7 B.3.1, B.8.7 (e), B.8.7 (m)
7.8 B.8.7 (h), B.8.7 (o)
7.9 B.8.7 (a), B.8.7 (c) See Note 3.
7.10 B.8.7 (a), B.8.7 (r), B.8.7 (s) See Note 3.
7.11 B.8.7 (f)
7.12 B.8.7 (g)
7.13 B.8.7 (k), B.8.7 (j)
7.14 B.8.7 (i)
7.15 B.8.7 (i)
7.16 B.8.7 (d), B.8.7 (h)
7.17 B.8.7 (l)
7.18 B.8.7 (h), B.8.7 (j)
GENERAL NOTE The presumption of conformity depends on applying all relevant requirements of ISO
18113-1.
NOTE 1 In the European Union, the name and address of the manufacturer’s “EC Authorized representative”
is required on the outer container label or in the instructions for use, if the legal manufacturer is not located
within the European Union.
NOTE 2 Essential requirement B.8.3 of Directive 98/79/EC should be consulted for a comprehensive list of the
information required.
NOTE 3 Essential requirement B.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of the
information required.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this International Standard.
INTERNATIONAL ISO
STANDARD 18113-2
First edition
2009-12-15
In vitro diagnostic medical devices —
Information supplied by the manufacturer
(labelling) —
Part 2:
In vitro diagnostic reagents for
professional use
Dispositifs médicaux de diagnostic in vitro — Informations fournies par
le fabricant (étiquetage) —
Partie 2: Réactifs de diagnostic in vitro à usage professionnel

Reference number
ISO 18113-2:2009(E)
©
ISO 2009
ISO 18113-2:2009(E)
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ISO 18113-2:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 General .2
4.1 Essential requirements.2
4.2 Identification of kit components .2
5 Content of the outer container label.2
5.1 Manufacturer.2
5.2 Identification of the IVD reagent .2
5.3 Contents .2
5.4 Intended use .2
5.5 In vitro diagnostic use .3
5.6 Storage and handling conditions .3
5.7 Expiry date .3
5.8 Warnings and precautions .3
6 Content of the immediate container label.3
6.1 General provisions .3
6.2 Manufacturer.4
6.3 Identification of the IVD reagent .4
6.4 Contents .4
6.5 In vitro diagnostic use .4
6.6 Storage and handling conditions .4
6.7 Expiry date .4
6.8 Warnings and precautions .
...