EN ISO 18113-1:2011

SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-1:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFDR]QDþHYDQMH
GHO,]UD]LGHILQLFLMHLQVSORãQH]DKWHYH,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1:
Begriffe und allgemeine Anforderungen (ISO 18113-1:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-1:2011
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 18113-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-1:2009
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 1: Terms, definitions and general
requirements (ISO 18113-1:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 1: Termes, durch den Hersteller - Teil 1: Begriffe und allgemeine
définitions et exigences générales (ISO 18113-1:2009) Anforderungen (ISO 18113-1:2009)
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 18113-1:2011: 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 18113-1:2011) 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 18113-1:2009.
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 18113-1:2009 has been approved by CEN as EN ISO 18113-1:2011 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
Presumption of conformity with
ER B.8.1 also requires
compliance with the relevant
clauses of EN ISO 18113-2, -3,
-4 and -5, as applicable.
Compliance with MEDDEV 2.14/3
“IVD Guidance: Supply of
Instructions For Use (IFU) and
4.1, 4.2.1, 4.6 B.8.1.
other information for In vitro
Diagnostic (IVD) Medical Devices
– A Guide for Manufacturers and
Notified Bodies“ is required to
ensure presumption of conformity
in the case where IFU are
provided separately from the IVD
device.
NOTE 1
Presumption of conformity with
ER B.8.2 also requires
compliance with the relevant
4.3 B.8.2.
clauses of EN 980, where
applicable.
4.5 B.8.4(c)
4.8 B.8.4( j)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this European Standard.
NOTE 1 MEDDEV 2.14/3 rev 1 (2007) is available from the European Commission’s website at the following
address: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_14_3_rev1_ifu_final_en.pdf .
INTERNATIONAL ISO
STANDARD 18113-1
First edition
2009-12-15
In vitro diagnostic medical devices —
Information supplied by the manufacturer
(labelling) —
Part 1:
Terms, definitions and general
requirements
Dispositifs médicaux de diagnostic in vitro — Informations fournies par
le fabricant (étiquetage) —
Partie 1: Termes, définitions et exigences générales

Reference number
ISO 18113-1:2009(E)
©
ISO 2009
ISO 18113-1:2009(E)
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ii © ISO 2009 – All rights reserved

ISO 18113-1:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General requirements for information supplied by the manufacturer.17
4.1 General .17
4.2 Language.18
4.3 Symbols and identification colours.18
4.4 Values and nomenclature.18
4.5 Microbiological state.18
4.6 Instructions for use .18
4.7 Changes to the IVD medical device.19
4.8 Disclosure of residual risks .19
4.9 Identification of components .20
4.10 Assistance.20
Annex A (informative) Performance characteristics of IVD medical devices .21
Bibliography.45

ISO 18113-1:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has
been established has the right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 18113-1 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
ISO 18113 consists of the following parts, under the general title In vitro diagnostic medical devices —
Information supplied by the manufacturer (labelling):
⎯ Part 1: Terms, definitions and general requirements
⎯ Part 2: In vitro diagnostic reagents for professional use
⎯ Part 3: In vitro diagnostic instruments for professional use
⎯ Part 4: In vitro diagnostic reagents for self-testing
⎯ Part 5: In vitro diagnostic instruments for self-testing
iv © ISO 2009 – All rights reserved

ISO 18113-1:2009(E)
Introduction
Manufacturers of in vitro diagnostic (IVD) medical devices supply users with information to enab
...