EN ISO 5649:2024
(Main)Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.
This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
Medizinische Laboratorien - Konzepte und Spezifikationen für den Entwurf, die Entwicklung, die Herstellung und den Einsatz hauseigener In‑vitro-Diagnostika (laborentwickelte Tests) (ISO 5649:2024)
Dieses Dokument legt Anforderungen fest, durch die Qualität, Sicherheit, Leistung und Dokumentation von laborentwickelten Tests (LDTs) entsprechend ihrer vorgesehenen Anwendung für die Diagnose, Prognose, Überwachung, Prävention oder Behandlung von Krankheiten sichergestellt werden.
Sie fasst die allgemeinen Grundsätze und Bewertungskriterien zusammen, entsprechend denen ein LDT für die hausinterne Verwendung durch medizinische Laboratorien gestaltet, entwickelt, charakterisiert, hergestellt, (analytisch und klinisch) validiert und überwacht werden muss.
Der Anwendungsbereich schließt behördlich zugelassene IVD-Medizinprodukte mit ein, die auf eine von der zugelassenen Kennzeichnung oder Gebrauchsanweisung für dieses Produkt abweichende Weise verwendet werden (z. B. Verwendung eines Probentyps, der nicht in der Gebrauchsanweisung angegeben ist, Verwendung von Geräten oder Reagenzien, die nicht in die Kennzeichnung einbezogen sind).
Dieses Dokument befolgt einen Ansatz der aktuellen bewährten Praxis nach dem Stand der Technik; es enthält aber weder spezifische Angaben, wie diese Anforderungen innerhalb spezifischer Fachbereiche des medizinischen Laboratoriums zu erreichen sind, noch spezifische Angaben zu technischen Plattformen.
Dieses Dokument legt keine Anforderungen an Untersuchungsverfahren fest, die von Forschungs- oder akademischen Laboratorien, die Testsysteme für andere als IVD-Zwecke entwickeln und verwenden, entwickelt werden. Die in diesem Dokument vorgestellten Konzepte können aber auch für diese Laboratorien von Nutzen sein.
Dieses Dokument gilt nicht für die Gestaltung, Entwicklung und industrielle Produktion von gewerblich verwendeten In-vitro-Diagnostika.
Laboratoires médicaux - Concepts et spécifications relatifs à la conception, au développement, à la mise en œuvre et à l’utilisation des tests développés en laboratoire (ISO 5649:2024)
Le présent document établit les exigences de garantie de la qualité, de la sécurité, des performances et de la documentation des tests développés en laboratoire (TDL) en fonction de leur utilisation prévue de diagnostic, suivi, prévention ou traitement d’états médicaux.
Elle présente les principes généraux et les critères d’évaluation par lesquels un TDL doit être conçu, développé, spécifié, fabriqué, validé (de façon analytique et clinique) et surveillé à des fins d’utilisation interne par les laboratoires médicaux.
Le domaine d’application inclut les dispositifs médicaux de DIV approuvés par l’autorité réglementaire, utilisés de façon différente de celle de l’étiquetage ou des instructions approuvés pour l’utilisation desdits dispositifs (par exemple, l’utilisation d’un type d’échantillon non inclus dans l’utilisation prévue ou l’utilisation d’instruments ou de réactifs ne figurant pas sur l’étiquetage).
Même si le présent document suit les bonnes pratiques actuelles et adopte une approche selon l’état de l’art, il ne fournit pas de détails spécifiques sur la façon de respecter ces exigences au sein des disciplines spécifiques du laboratoire médical, ni sur les plateformes technologiques spécifiques.
Le présent document ne spécifie pas les exigences des procédures d’examen développées par les laboratoires de recherche ou universitaires développant et utilisant des systèmes d’examen à des fins autres que le diagnostic in vitro. Toutefois, les concepts présentés dans le présent document peuvent également se révéler utiles pour lesdits laboratoires.
Le présent document ne s’applique pas à la conception, au développement et à la production industrielle des dispositifs médicaux de DIV utilisés sur le marché.
Medicinski laboratoriji - Koncepti in specifikacije za oblikovanje, razvoj, izvajanje in uporabo laboratorijsko razvitih testov (ISO 5649:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 5649:2024
01-marec-2024
Medicinski laboratoriji - Koncepti in specifikacije za oblikovanje, razvoj, izvajanje
in uporabo laboratorijsko razvitih testov (ISO/DIS 5649:2023)
Medical laboratories - Concepts and specifications for the design, development,
implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023)
Medizinische Laboratorien - Konzepte und Spezifikationen für den Entwurf, die
Entwicklung, die Herstellung und den Einsatz hauseigener In‑vitro-Diagnostika
(laborentwickelte Tests) (ISO/DIS 5649:2023)
Laboratoires médicaux - Concepts et spécifications relatifs à la conception, au
développement, à la mise en œuvre et à l’utilisation des tests développés en laboratoire
(ISO/DIS 5649:2023)
Ta slovenski standard je istoveten z: prEN ISO 5649
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
oSIST prEN ISO 5649:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 5649:2024
oSIST prEN ISO 5649:2024
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5649
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-12-25 2024-03-18
Medical laboratories - Concepts and specifications for
the design, development, implementation, and use of
laboratory-developed tests
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 5649:2023(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
oSIST prEN ISO 5649:2024
ISO/DIS 5649:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5649
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
Medical laboratories - Concepts and specifications for
the design, development, implementation, and use of
laboratory-developed tests
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 5649:2023(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
oSIST prEN ISO 5649:2024
ISO/DIS 5649:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements .17
4.1 Rationale for laboratory-developed tests . . 17
4.2 Feasibility assessment . 18
4.3 Quality management system . 18
4.3.1 General . 18
4.3.2 Transfer of devices . 19
4.3.3 Control of subcontractors . 19
5 Requirements for the design and development of laboratory-developed tests .19
5.1 Determination of LDT performance specifications . 19
5.1.1 Intended use .20
5.1.2 Scientific validity .20
5.1.3 Scientific literature . 21
5.2 Risk management . 21
5.2.1 Risk management system . 21
5.2.2 Risk differentiation for the LDT. 22
5.3 Essential principles for safety and performance . 22
5.3.1 Applicable principles . 22
5.4 Preliminary and pilot testing .23
6 Requirements for the performance evaluation of laboratory-developed tests .23
6.1 Performance evaluation . 23
6.2 Validation master plan . 24
6.3 Analytical performance . 24
6.3.1 Measurement Uncertainty . 25
6.4 Clinical performance .25
6.5 Excluded performance characteristics . 26
6.6 Software validation and verification . 26
6.7 Validation documentation and final acceptance criteria . 26
6.8 Post validation activities of verification . 27
7 Implementation, monitoring and retirement of laboratory-developed tests .28
7.1 Transfer into routine use .28
7.2 Result reporting and interpretation .28
7.3 Maintenance .28
7.4 Monitoring and review activities .28
7.5 Change management .29
7.6 Retirement of laboratory-developed tests.29
Annex A (informative) .30
Bibliography .33
iii
oSIST prEN ISO 5649:2024
ISO/DIS 5649:2023(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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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.
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
oSIST prEN ISO 5649:2024
ISO/DIS 5649:2023(E)
Introduction
Medical laboratory testing must be carried out to an appropriate standard and all work must be
performed with a high level of skill and competence so as not to produce unreliable results which can
lead to patient harm.
In many medical laboratories, the majority of routine clinical samples are processed and analyzed using
commercially available tests on automated instrumentation purchased from various manufacturers
of in vitro diagnostic (IVD) medical devices. The marketing of medical devices is usually regulated
by national bodies and devices must undergo stringent assessment before they can
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.