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
01-februar-2025
Medicinski laboratoriji - Koncepti in specifikacije za oblikovanje, razvoj, izvajanje
in uporabo laboratorijsko razvitih testov (ISO 5649:2024)
Medical laboratories - Concepts and specifications for the design, development,
implementation, and use of laboratory-developed tests (ISO 5649:2024)
Medizinische Laboratorien - Konzepte und Spezifikationen für den Entwurf, die
Entwicklung, die Herstellung und den Einsatz hauseigener In‑vitro-Diagnostika
(laborentwickelte Tests) (ISO 5649:2024)
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)
Ta slovenski standard je istoveten z: EN ISO 5649:2024
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5649
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 11.100.10
English Version
Medical laboratories - Concepts and specifications for the
design, development, implementation, and use of
laboratory-developed tests (ISO 5649:2024)
Laboratoires médicaux - Concepts et spécifications Medizinische Laboratorien - Konzepte und
relatifs à la conception, au développement, à la mise en Spezifikationen für den Entwurf, die Entwicklung, die
œuvre et à l'utilisation des tests développés en Herstellung und den Einsatz hauseigener In-vitro-
laboratoire (ISO 5649:2024) Diagnostika (laborentwickelte Tests) (ISO 5649:2024)
This European Standard was approved by CEN on 6 December 2024.
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 5649:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5649:2024) 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 June 2025, and conflicting national standards shall be
withdrawn at the latest by December 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.
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 5649:2024 has been approved by CEN as EN ISO 5649:2024 without any modification.
International
Standard
ISO 5649
First edition
Medical laboratories — Concepts
2024-11
and specifications for the design,
development, implementation and
use of laboratory-developed tests
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
Reference number
ISO 5649:2024(en) © ISO 2024
ISO 5649:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Published in Switzerland
ii
ISO 5649:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 16
4.1 Rationale for laboratory-developed tests (LDTs) .16
4.2 Feasibility assessment .17
4.3 Management system .17
4.3.1 General .17
4.3.2 Transfer of laboratory-developed tests (LDTs) .18
4.3.3 Control of subcontractors .18
5 Requirements for the design and development of laboratory-developed tests (LDTs) .18
5.1 Determination of LDT performance specifications .18
5.1.1 General .18
5.1.2 Intended use .19
5.1.3 Scientific validity . 20
5.1.4 Scientific literature . 20
5.2 Risk management . 20
5.2.1 Risk management system . 20
5.2.2 Risk differentiation for the LDT.21
5.3 Essential principles for safety and performance .21
5.4 Preliminary and pilot testing . 22
6 Requirements for the performance evaluation of laboratory-developed tests (LDTs) .22
6.1 Performance evaluation . 22
6.2 Validation master plan . 23
6.3 Analytical performance . 23
6.3.1 General . 23
6.3.2 Measurement uncertainty (MU) .24
6.4 Clinical performance .24
6.5 Excluded performance characteristics . 25
6.6 Software verification and validation . 25
6.7 Validation documentation and final acceptance criteria . 25
6.8 Post validation activities of verification . 26
7 Implementation, monitoring and retirement of laboratory-developed tests (LDTs) .27
7.1 Transfer into routine use .27
7.2 Result reporting and interpretation .27
7.3 Maintenance .27
7.4 Monitoring and review activities .27
7.5 Change management . 28
7.6 Retirement of laboratory-developed tests (LDTs) . 28
Annex A (informative) Example workflow for a laboratory-developed test (LDT) lifecycle .29
Bibliography .31
iii
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