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)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.
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 der 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.
Darüber hinaus gilt dieser Teil der ISO 18113 auch für die Bereitstellung von Informationen durch den Hersteller von Kalibriermaterialien und Kontrollmaterialien, die für den Gebrauch mit In-vitro-Diagnostika durch Fachpersonal vorgesehen sind.
Sofern zutreffend, kann dieser Teil der ISO 18113 auch auf Zubehör angewendet werden.
Dieser Teil der ISO 18113 gilt für Etiketten für die äußeren und Primärbehälter sowie die Gebrauchs¬anweisung.
Der vorliegende Teil der ISO 18113 gilt nicht für:
a) Datenblätter zur Materialsicherheit;
b) Bereitstellung von Informationen für Reagenzien zur Leistungsbewertung (z. B. nur für Forschungs-zwecke);
c) IVD-Geräte oder Ausrüstungen; oder
d) 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18113-2:2010
01-marec-2010
1DGRPHãþD
SIST EN 375:2001
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]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
SIST EN ISO 18113-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 18113-2:2010
---------------------- Page: 2 ----------------------
SIST EN ISO 18113-2:2010
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 18113-2:2010
EN ISO 18113-2:2009 (E)
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
2
---------------------- Page: 4 ----------------------
SIST EN ISO 18113-2:2010
EN ISO 18113-2:2009 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 18113-2:2010
EN ISO 18113-2:2009 (E)
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)
4
---------------------- Page: 6 ----------------------
SIST EN ISO 18113-2:2010
EN ISO 18113-2:2009 (E)
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)
5
---------------------- Page: 7 ----------------------
SIST EN ISO 18113-2:2010
EN ISO 18113-2:2009 (E)
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.
6
---------------------- Page: 8 ----------------------
SIST EN ISO 18113-2:2010
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
---------------------- Page: 9 ----------------------
SIST EN ISO 18113-2:2010
ISO 18113-2:2009(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.
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 10 ----------------------
SIST EN ISO 18113-2:2010
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 .4
7 Content of the instructions for use .5
7.1 Manufacturer.5
7.2 Identification of the IVD reagent .5
7.3 Intended use .5
7.4 Principles of the examination method .5
7.5 Traceability of values assigned to calibrators and trueness-control materials .5
7.6 Components.6
7.7 Additional required equipment .6
7.8 Reagent preparation.6
7.9 Storage and shelf life after first opening .6
7.10 Warnings and precautions .6
7.11 Primary sample collection, handling and storage .7
7.12 Examination procedure.7
7.13 Control procedure .7
7.14 Calculation of examination results.7
7.15 Interpretation of results .7
7.16 Performance characteristics .7
7.17 Biological reference intervals .8
7.18 Limitations of the examination procedure.8
7.19 Literature references.8
Bibliography.9
© ISO 2009 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 18113-2:2010
ISO 18113-2:2009(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 18113-2 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
---------------------- Page: 12 ----------------------
SIST EN ISO 18113-2:2010
ISO 18113-2:2009(E)
Introduction
Manufacturers of in vitro diagnostic (IVD) reagents for professional use supply users with information to
enable their safe use and the expected performance of their devices. The type and level of detail varies
according to the intended uses and country-specific regulations.
The Global Harmonization Task Force (GHTF) encourages convergence of the evolution of regulatory
systems for medical devices at the global level. Eliminating differences among regulatory jurisdictions could
allow patients earlier access to new technologies and treatments. See Reference [9]. This part of ISO 18113
provides a basis for harmonization of labelling requirements for IVD reagents for professional use.
This part of ISO 18113 is concerned solely with information supplied with IVD reagents, calibrators and control
materials intended for professional use. It is intended to be used in conjunction with ISO 18113-1, which
contains the general requirements for information supplied by the manufacturer and definitions of general
labelling concepts.
[5]
This part of ISO 18113 is based on EN 375:2001 . The text has been modified to conform to Part 2 of the
[4]
, but the requirements, including those in ISO 18113-1, are substantially equivalent to the
ISO/IEC Directives
original European harmonized standard. This part of ISO 18113 is intended to support the essential labelling
requirements of all the GHTF partners, as well as other countries that have or plan to enact labelling
regulations for IVD medical devices.
For IVD reagents, calibrators and/or control materials that are intended
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.