oSIST prEN ISO 5649:2024

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.

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oSIST prEN ISO 5649:2024

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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,
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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

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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.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
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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.
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WHICH REFERENCE MAY BE MADE IN
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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
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 5649:2024
ISO/DIS 5649:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...