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oSIST prEN ISO 15194:2024

(Main)

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

DOW = DAV + 36 months

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)

Diagnostični medicinski pripomočki in vitro - Zahteve za certificirane referenčne materiale in vsebino podporne dokumentacije (ISO/DIS 15194:2023)

General Information

Status
Not Published
Public Enquiry End Date
17-Mar-2024
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
04-Jan-2024
Due Date
23-May-2024
Completion Date
15-Feb-2024
Directive
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
prEN ISO 15194 - In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

Relations

Replaces
SIST EN ISO 15194:2009 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
Effective Date
10-Mar-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 15194:2024
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
oSIST prEN ISO 15194:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 15194:2024

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oSIST prEN ISO 15194:2024
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

---------------------- Page: 3 ----------------------
oSIST prEN ISO 15194:2024
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.
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
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
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 15194:2024
ISO/DIS 15194:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...

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