prEN ISO 15194

SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 15194:2009
Diagnostični medicinski pripomočki in vitro - Zahteve za certificirane referenčne
materiale in vsebino podporne dokumentacije (ISO/DIS 15194:2023)
In vitro diagnostic medical devices - Requirements for certified reference materials and
the content of supporting documentation (ISO/DIS 15194:2023)
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs -
Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der
Begleitdokumentation (ISO/DIS 15194:2023)
Dispositifs médicaux de diagnostic in vitro Mesurage des grandeurs dans les
échantillons d'origine biologique Exigences relatives aux matériaux de référence
certifiés et au contenu de la documentation associée (ISO/DIS 15194:2023)
Ta slovenski standard je istoveten z: prEN ISO 15194
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.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15194
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-12-26 2024-03-19
In vitro diagnostic medical devices — Requirements for
certified reference materials and the content of supporting
documentation
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15194:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15194:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15194
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:

In vitro diagnostic medical devices — Requirements for
certified reference materials and the content of supporting
documentation
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15194:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15194:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended use, production and characterization of a Certified Reference Material
(CRM) . 9
4.1 Intended Use . 9
4.2 Production and certification . 9
4.3 Commutability . 9
5 Content of supporting documentation . 9
5.1 Supporting documentation. 9
5.2 Label . 10
5.3 Reference Material Certificate. 10
5.4 Certification Report . 11
5.4.1 General . 11
5.4.2 Warning and safety precautions .12
5.4.3 Introduction . 12
5.4.4 Scope of application for the CRM .12
5.4.5 Terms and Definitions .12
5.4.6 General properties .13
5.4.7 Specific properties . 13
5.4.8 Assignment of certified values . 15
5.4.9 Intended use . 16
5.4.10 Instructions for use. 16
5.4.11 Reference material Producer . 17
5.4.12 Bibliography . 17
5.4.13 Annexes . 18
5.4.14 Dates of authorization and revision . 18
Annex A (informative) Certified reference materials with nominal properties or ordinal
quantities .19
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .20
Bibliography .23
iii
ISO/DIS 15194:2023(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
This third edition cancels and replaces the second edition (ISO 15194:2009), which has been technically
revised.
The main changes are as follows:
— incorporated requirements, concepts and definitions for consistency with ISO 17511:2020;
— removed or reduced text regarded as redundant or of limited relevance. As a result Section 4 in the
second edition - Systematic designation of CRM properties - has been deleted;
— expanded and clarified the Scope statement to specify requirements for higher-order CRMs whose
intended for use is to underpin routine measurements in laboratory medicine;
— added requirements regarding description of the intended use and commutability of the CRM; and
— strengthened the documentation requirements for both the certificate and the certification report
accompanying a CRM.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 15194:2023(E)
Introduction
Reference measurement systems are needed to enable the results produced by end user measurement
procedures to be metrologically traceable to measurement standards and/or measurement procedures
of the highest metrological level. Such systems exist within a traceability chain/calibration hierarchy as
described in ISO 17511:2020. In the context of in vitro diagnostic (IVD) medical devices, they mitigate
the risk of harm to patients by avoiding inconsistent results from different measurement systems.
Substances that are used to establish and maintain this metrological traceability of measurement
results - over time within one location, between different physical locations or with the application
of different measurement procedures - are Reference Materials (RMs). Certified Reference Materials
(CRMs) are a category of RMs required at the higher metrol
...