SIST EN ISO 18113-2:2012

SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-2:2010
'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 18113-2:2011
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 18113-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-2:2009
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 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 18113-2:2011: 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 18113-2:2011) 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 18113-2:2009.
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 18113-2:2009 has been approved by CEN as EN ISO 18113-2:2011 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 Directive 98/79/EC
Clauses of this European Essential requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes
This standard only covers the
second sentence of ER B.3.1
7.7 B.3.1
namely the labelling
requirements.
Presumption of conformity
with ER B.8.1 also requires
B.8.1 compliance with clauses 4.1,
5, 6, 7
4.2.1 and 4.6 of
EN ISO 18113-1.
NOTE 2
5.8, 6.8, 7.10 B.8.3
NOTE 1
5.1, 6.2 B.8.4 (a)
5.2.1, 5.3, 6.3.1, 6.4 B.8.4 (b)
Full compliance with ER B.8.4
(d) requires the use of
5.2.2, 6.3.2 B.8.4 (d)
EN 980, 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)
5.8, 6.8 B.8.4 (j) NOTE 2
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
EN ISO 18113-1, clause 4.5,
7.1, 7.2, 7.9, 7.10 B.8.7 (a)
as well as an indication of the
in vitro use of the device.
NOTE 1, NOTE 3
7.6 B.8.7 (b)
NOTE 3
7.9 B.8.7 (c)
7.16 B.8.7 (d)
7.7 B.8.7 (e)
7.11 B.8.7 (f)
Clauses of this European Essential requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes

7.12 B.8.7 (g)
Full compliance with ER B.8.7
(h) requires, where applicable,
an indication of any particular
7.4, 7.8, 7.16, 7.18 B.8.7 (h)
training needed to operate the
device.
7.14, 7.15 B.8.7 (i)
7.18, 7.13 B.8.7 (j)
7.5, 7.13 B.8.7 (k)
7.17 B.8.7 (l)
7.7 B.8.7 (m)
7.8 B.8.7 (o)
NOTE 3
7.10 B.8.7 (r)
NOTE 3
7.10 B.8.7 (s)
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 18113-2
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 .
...