EN ISO 18113-4:2009

SLOVENSKI STANDARD
01-marec-2010
1DGRPHãþD
SIST EN 376:2002
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFDR]QDþHYDQMH
GHO'LDJQRVWLþQLUHDJHQWLLQYLWUR]DVDPRSUHVNXãDQMH,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4:
Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113
-4:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 4: Réactifs de diagnostic in vitro pour auto-tests (ISO 18113-4:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-4:2009
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 18113-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2009
ICS 11.100.10 Supersedes EN 376:2002
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 4: In vitro diagnostic reagents for
self-testing (ISO 18113-4:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 4: Réactifs de durch den Hersteller - Teil 4: Reagenzien für in-vitro-
diagnostic in vitro pour auto-tests (ISO 18113-4:2009) diagnostische Untersuchungen zur Eigenanwendung (ISO
18113-4:2009)
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 18113-4:2009: 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 18113-4:2009) 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 376:2002.
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 18113-4:2009 has been approved by CEN as a EN ISO 18113-4:2009 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
4.2 B.8.1, B.8.2
4.3 B.7, B.8.1, B.8.2
5.1 B.8.4 (a) See Note 1.
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.7, B.8.1, B.8.2
6.2 B.8.4 (a)
6.3.1 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
6.3.2 B.8.4 (d), B.8.6
6.4 B.8.4 (b)
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)
7.3 B.7, B.8.5
7.4 B.8.7 (h)
7.5 B.8.7 (b)
7.6 B.3.1, B.8.7 (e), B.8.7 (m)
7.7 B.8.7 (h)
7.8 B.8.7 (a), B.8.7 (c)
7.9 B.8.7 (a), B.8.7 (s)
7.10 B.8.7 (f)
7.11 B.7, B.8.7 (g)
7.12 B.8.7 (k) See Note 3.
7.13 B.8.7 (t)
7.14 B.8.7 (t)
7.15 B.8.7 (t)
7.16 B.8.7 (t)
7.17 B.8.7 (t)
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 18113-4
First edition
2009-12-15
In vitro diagnostic medical devices —
Information supplied by the manufacturer
(labelling) —
Part 4:
In vitro diagnostic reagents for self-
testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies par
le fabricant (étiquetage) —
Partie 4: Réactifs de diagnostic in vitro pour auto-tests

Reference number
ISO 18113-4:2009(E)
©
ISO 2009
ISO 18113-4:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved

ISO 18113-4:2009(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
4.3 Presentation of the instructions for use .2
5 Content of the outer container label.2
5.1 Manufacturer.2
5.2 Identification of the IVD reagent .2
5.3 Contents .3
5.4 Intended use .3
5.5 In vitro diagnostic use .3
5.6 Storage and handling conditions .3
5.7 Expiry date .3
5.8 Warnings and precautions .4
6 Content of the immediate container label.4
6.1 General provisions .4
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 .5
6.7 Expiry date .5
6.8 Warnings and precautions .
...