SIST EN ISO 18113-4:2012
(Main)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 diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 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 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009)
Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für in vitro diagnostische Untersuchungen zur Eigenanwendung fest.
Dieser Teil von ISO 18113 gilt auch für die Bereitstellung von Informationen durch den Hersteller von Kalibriermaterialien und Kontrollmaterialien, die für den Gebrauch mit In vitro Diagnostika für Untersuchungen zur Eigenanwendung vorgesehen sind.
Dieser Teil von ISO 18113 kann auch auf Zubehör angewendet werden.
Dieser Teil von ISO 18113 gilt für Etiketten für die äußeren und Primärbehälter sowie für die Gebrauchs-anleitung.
Der vorliegende Teil von ISO 18113 gilt nicht für:
a) IVD Geräte oder Ausrüstungen;
b) IVD Reagenzien zum Gebrauch durch Fachpersonal.
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)
L'ISO 18113-4:2009 spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de DIV pour auto-tests.
L'ISO 18113-4:2009 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 auto-tests.
L'ISO 18113-4:2009 peut aussi s'appliquer aux accessoires, le cas échéant.
L'ISO 18113-4:2009 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) - 4. del: Diagnostični reagenti in vitro za samopreskušanje (ISO 18113-4:2009)
Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih reagentov in vitro za samopreskušanje. Ta del ISO 18113 velja tudi za informacije proizvajalca glede kalibratorjev in kontrolnih materialov, ki se uporabljajo z diagnostičnimi preskusnimi sistemi in vitro za samopreskušanje. 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 poklicno uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-4:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]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 18113-4:2011
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
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-4:2009
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 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 18113-4:2011: 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 18113-4:2011) 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 18113-4:2009.
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.
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, 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.
Endorsement notice
The text of ISO 18113-4:2009 has been approved by CEN as EN ISO 18113-4:2011 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.1 confers, within the limits of the scope of this European Standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this European Standard and European Directive 98/79/EC
Clauses of this European Essential Requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes
These clauses only cover the
second sentence of ER B.7,
4.3, 6.1, 7.3, 7.11 B.7
namely the labelling
requirements.
Presumption of conformity with
ER B.8.1 also requires
4.2, 4.3, 5, 6, 7 B.8.1
compliance with clauses 4.1,
4.2.1 and 4.6 of EN ISO 18113-1.
NOTE 2
5.8, 6.8, 7.9 B.8.3
NOTE 1
5.1, 6.2 B.8.4(a)
5.2, 5.3, 6.3.1, 6.4 B.8.4(b)
Full compliance to ER B.8.4(d)
requires the use of EN 980,
5.2.2, 6.3.2 B.8.4(d)
clause 5.4, symbol (LOT).
5.7, 6.7 B.8.4(e)
5.5, 6.5 B.8.4(g)
5.6, 6.6 B.8.4(h)
NOTE 2
5.8, 6.8 B.8.4(j)
5.4 B.8.4(k)
5.4, 7.3 B.8.5
5.2.2, 6.3.2 B.8.6
Presumption of conformity with
ER B. 8.7(a) requires also
compliance with clause 4.5 of
7.1, 7.2, 7.3, 7.8, 7.9 B.8.7(a)
EN ISO 18113-1.
NOTE 1, NOTE 3
7.5 B.8.7(b)
7.8 B.8.7(c)
7.6 B.8.7(e)
7.10 B.8.7(f)
7.11 B.8.7(g)
Clauses of this European Essential Requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes
7.4, 7.7 B.8.7(h)
NOTE 3
7.12 B.8.7(k)
7.6 B.8.7(m)
7.9 B.8.7(s)
7.13, 7.14, 7.15, 7.16, 7.17 B.8.7(t)
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.
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)
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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 .
...
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