SIST EN ISO 18113-5:2012

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009)

Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung fest.
Dieser Teil von ISO 18113 gilt auch für Geräte und Ausrüstungen, die für den Gebrauch von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung vorgesehen sind.
Dieser Teil von ISO 18113 kann auch auf Zubehör angewendet werden.
Der vorliegende Teil von ISO 18113 gilt nicht für:
a)   Anweisungen für die Geräteinstandhaltung oder  reparatur;
b)   IVD Reagenzien, einschließlich Kalibriermittel und Kontrollmaterialien zur Kontrolle des Reagenz; oder
c)   IVD Instrumente zum Gebrauch durch Fachpersonal.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009)

L'ISO 18113-5:2009 spécifie les exigences relatives aux informations fournies par le fabricant d'instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 s'applique aussi aux appareillages et aux équipements destinés à être utilisés avec les instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 peut aussi s'appliquer aux accessoires, le cas échéant.

Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 5. del: Diagnostični instrumenti in vitro za samopreskušanje (ISO 18113-5:2009)

Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih instrumentov in vitro za samopreskušanje. Ta del ISO 18113 velja tudi za aparate in opremo, ki se uporabljajo z diagnostičnimi instrumenti in vitro za samopreskušanje. Ta del ISO 18113 lahko velja tudi za dodatno opremo. Ta del ISO 18113 ne velja za a) navodila za servisiranje ali popravilo instrumentov; b) diagnostične reagente in vitro, vključno s kalibratorji in kontrolnimi materiali, ki se uporabljajo pri nadzoru reagenta; c) diagnostične instrumente in vitro za poklicno uporabo.

General Information

• Status: Published
• Publication Date: 14-Dec-2011
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Nov-2011
• Due Date: 30-Jan-2012
• Completion Date: 15-Dec-2011
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: EN ISO 18113-5:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Relations

• Replaces: SIST EN ISO 18113-5:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
• Effective Date: 01-Jan-2012
• Revises: kSIST FprEN ISO 18113-5:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
• Effective Date: 18-Jan-2023
• Revises: kSIST FprEN ISO 18113-5:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
• Effective Date: 19-Jan-2023
• Revised: kSIST FprEN ISO 18113-5:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
• Effective Date: 27-Nov-2019
• Replaces: SIST EN ISO 18113-5:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18113-5:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-5:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFDR]QDþHYDQMH
GHO'LDJQRVWLþQLLQVWUXPHQWLLQYLWUR]DVDPRSUHVNXãDQMH,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5:
Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-
5:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-
5:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-5:2011
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 18113-5:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18113-5:2012

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SIST EN ISO 18113-5:2012


EUROPEAN STANDARD
EN ISO 18113-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-5:2009
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 5: In vitro diagnostic instruments
for self-testing (ISO 18113-5:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 5: Instruments durch den Hersteller - Teil 5: Geräte für in-vitro-
de diagnostic in vitro pour auto-tests (ISO 18113-5:2009) diagnostische Untersuchungen zur Eigenanwendung (ISO
18113-5:2009)
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 18113-5:2011: E
worldwide for CEN national Members.

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SIST EN ISO 18113-5:2012
EN ISO 18113-5:2011 (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

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SIST EN ISO 18113-5:2012
EN ISO 18113-5:2011 (E)
Foreword
This document (EN ISO 18113-5:2011) 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 18113-5:2009.
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 18113-5:2009 has been approved by CEN as EN ISO 18113-5:2011 without any modification.
3

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SIST EN ISO 18113-5:2012
EN ISO 18113-5:2011 (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.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,
namely the labelling
6, 7.3, 7.11 B.7
requirements.
NOTE 2

7.12 B.7.2
Presumption of conformity with
ER B.8.1 also requires
compliance with clauses 4.1,
5, 6, 7 B.8.1
4.2.1 and 4.6 of EN ISO 18113-1.


5.2.1 B.8.4(b)
Full compliance to ER B.8.4(d)
requires the use of EN 980,
5.2.2 B.8.4(d) clause 5.4 symbol (LOT) or
EN 980, clause 5.5 symbol
(SN), as applicable.

5.2.3 B.8.4(g)

7.3 B.8.5
Presumption of conformity with
ER B.8.7(a) requires also
compliance with clause 4.5 of
6, 7.1, 7.2, 7.3, 7.4, 7.5, 7.11 B.8.7(a) EN ISO 18113-1.
NOTE 1,
NOTE 2

7.8 B.8.7(d)

7.2.2, 7.10 B.8.7(e)
7.10 B.8.7(f)
NOTE 2
7.11, 7.14, 7.15 B.8.7(g)
NOTE 2
7.7, 7.8, 7.9, 7.10, 7.11 B.8.7(h)

7.18 B.8.7(j)

7.12, 7.14 B.8.7(k)
4

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SIST EN ISO 18113-5:2012
EN ISO 18113-5:2011 (E)
Clauses of this European Essential Requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes

7.6, 7.10 B.8.7(m)
7.6, 7.10, 7.14, 7.16, 7.17 B.8.7(n)

7.10 B.8.7(o)
      NOTE 2
7.5, 7.16 B.8.7(s)
7.7, 7.12, 7.13, 7.14, 7.18,

B.8.7(t)
7.19

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.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of the
information required.


5

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SIST EN ISO 18113-5:2012

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SIST EN ISO 18113-5:2012

INTERNATIONAL ISO
STANDARD 18113-5
First edition
2009-12-15

In vitro diagnostic medical devices —
Information supplied by the manufacturer
(labelling) —
Part 5:
In vitro diagnostic instruments for self-
testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies par
le fabricant (étiquetage) —
Partie 5: Instruments de diagnostic in vitro pour auto-tests



Reference number
ISO 18113-5:2009(E)
©
ISO 2009

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SIST EN ISO 18113-5:2012
ISO 18113-5:2009(E)
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ii © ISO 2009 – All rights reserved

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SIST EN ISO 18113-5:2012
ISO 18113-5:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Essential requirements.2
5 Labels and marking.2
5.1 General .2
5.2 Identification of the IVD instrument.2
6 Elements of the instructions for use .3
7 Content of the instructions for use .3
7.1 Manufacturer.3
7.2 Identification of the IVD instrument.3
7.3 Intended use .4
7.4 Storage and handling.4
7.5 Warnings and precautions .4
7.6 Instrument installation.4
7.7 Principles of measurement .5
7.8 Performance of the IVD instrument .5
7.9 Limitations of use.5
7.10 Preparation prior to operation .5
7.11 Operating procedure .5
7.12 Control procedure .6
7.13 Reading of examination results .6
7.14 Special functions.6
7.15 Shut-down procedure .6
7.16 Disposal information.6
7.17 Maintenance.7
7.18 Troubleshooting .7
7.19 Follow-up action.7
Bibliography.8

© ISO 2009 – All rights reserved iii

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SIST EN ISO 18113-5:2012
ISO 18113-5:2009(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 18
...