SIST EN ISO 18113-2:2024

SLOVENSKI STANDARD
01-september-2024
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 2.
del: Diagnostični reagenti in vitro za strokovno uporabo (ISO 18113-2:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-
vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-
2:2022)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 2: Réactifs de diagnostic in vitro à usage professionnel (ISO 18113-
2:2022)
Ta slovenski standard je istoveten z: EN ISO 18113-2:2024
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18113-2
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2024
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 18113-2:2011
English Version
In vitro diagnostic medical devices - Information supplied
by the manufacturer (labelling) - Part 2: In vitro diagnostic
reagents for professional use (ISO 18113-2:2022)
Dispositifs médicaux de diagnostic in vitro - In-vitro-Diagnostika - Bereitstellung von
Informations fournies par le fabricant (étiquetage) - Informationen durch den Hersteller - Teil 2: In-vitro-
Partie 2: Réactifs de diagnostic in vitro à usage diagnostische Reagenzien für den Gebrauch durch
professionnel (ISO 18113-2:2022) Fachpersonal (ISO 18113-2:2022)
This European Standard was approved by CEN on 2 October 2022.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 4

European foreword
This document (EN ISO 18113-2:2024) has been prepared by Technical Committee ISO/TC 212
"Medical laboratories and in vitro diagnostic 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 December 2024, and conflicting national standards
shall be withdrawn at the latest by June 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18113-2:2011.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 18113-2:2022 has been approved by CEN as EN ISO 18113-2:2024 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
For the purpose of using this standard in support of the requirements set out in Regulation (EU)
2017/746, the definitions set out in this Regulation prevail.
This document needs to be considered together with the other parts of EN ISO 18113-series to fully
apply the concepts of this labelling standard series. EN ISO 18113-1 provides definitions and overall
concepts which may be further applied or directed to specific device format and labelling location.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the In vitro Diagnostic
Regulation (EU) 2017/746).
Where the standard includes notes that require alignment to local or regional regulations, all clauses
need to be read in the context of Regulation (EU) 2017/746.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/746 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/746
20.2 a) 5.2.1, 6.3.1 Covered
20.2 (b) 5.2.1., 5.4., 6.3.1, Covered
20.2 c) 5.1, 6.2 Covered
20.2 e) 5.5, 6.5 Covered with respect to the
indication of in-vitro diagnostic
medical device
20.2 f) 5.2.2, 6.3.2 Covered
20.2 h) 5.7, 6.7 Covered
20.2 j) 5.3 Covered
20.2 k) 5.6, 6.6 Covered
20.2 q) 5.4 Covered with respect to
indication that the device is
intended for near patient
testing
20.2 t) 5.2.2, 6.3.2 Covered with respect to
identification of the
components by batch code
20.4.1 a) 7.2. Covered
20.4.1 b) 7.2 Covered
st
20.4.1 c) i) 7.3 1 bullet Covered
th
20.4.1 c) ii) 7.3 4 bullet Covered

th
20.4.1 c) iii) 7.3 6 bullet Covered with respect to the
impairment, condition, or
predisposition
th
20.4.1 c) iv) 7.3 8 bullet Covered
th
20.4.1 c) v) 7.3 5 bullet Covered with respect to
qualitative and quantitative
examinations
rd
20.4.1 c) vi) 7.3 3 bullet Covered
nd
20.4.1 c) vii) 7.3 2 bullet Covered
th
20.4.1 e) 7.3 7 bullet Covered
20.4.1 f) 7.4 Covered
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/746
20.4.1 h) 7.6, 7.10 Covered with respect to the
nature, amount, concentration
of the reactive ingredients,
Covered with respect to
limitations of use
20.4.1 i) 7.6, 7.7 Covered
20.4.1 j) 7.7 Covered with respect to listing
further equipment and
ensuring proper and safe
combination for use
20.4.1 k) 7.9., 7.10 Covered with respect to storage
20.4.1 l) 7.9 Covered
st
20.4.1 n) i) 7.10., 1 bullet Covered

20.4.1 n) ii) 7.10, Covered
20.4.1 n) v) 7.10 last sentence Covered

th
20.4.1 o) 7.10, 6 indent Covered
20.4.1 q) 7.11 Covered
20.4.1 r) 7.8 Covered with respect to
reagent preparation.
20.4.1 t) 7.13 Covered
20.4.1 u) 7.5 Covered
20.4.1. v) 7.5, 7.14, 7.15 Covered
20.4.1 w) 7.16.1 Covered with respect to
describing analytical
performance characteristics
relevant to the intended uses
20.4.1. x) 7.16.2 Covered with respect to
diagnostic sensitivity and
specificity
20.4.1 y) 7.14 Covered
20.4.1. z) 7.16.2 Covered
20.4.1 aa) 7.17 Covered
20.4.1 ab) 7.18 Covered
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/746
20.4.1 ac) i) 7.10. Covered.
20.4.1 ad) 7.1 Covered
20.4.1 ae) 7.20 Covered with respect to
document and change control
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 8601-1 ISO 8601-1:2019 Date and time — For applicable standard
Representations for information edition see Column 2
interchange — Part 1: Basic rules
ISO 8601-2 ISO 8601-2:2019 Representations for information For applicable standard
interchange — Part 2: Extensions edition see Column 2
ISO 14971 ISO 14971:2019 Medical devices — Application of EN ISO 14971:2019
risk management to medical
EN ISO 14971:2019/A11:2021
devices
ISO 15223-1 ISO 15223-1:2021 Medical devices — Symbols to be EN ISO 15223-1:2021
used with information to be
supplied by the manufacturer —
Part 1: General requirements
ISO 18113-1 ISO 18113-1:2022 In vitro diagnostic medical EN ISO 18113-1:2024
devices — Information supplied
by the manufacturer (labelling)
— Part 1: Terms, definitions, and
general requirements
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 18113-2
Second edition
2022-10
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 18113-2:2022(E)
ISO 18113-2:2022(E)
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