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CEN

FprEN ISO 18113-4

(Main)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO/FDIS 18113-4:2022)

Dieses Dokument legt Anforderungen an die durch den Hersteller von in vitro-diagnostischen (IVD )Reagenzien,  Kalibriermaterialien und  Kontrollmaterialien für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest.
Dieses Dokument kann auch auf Zubehör angewendet werden.
Dieses Dokument gilt für Etiketten für die äußeren und Primärbehälter sowie für die Gebrauchsanleitung.
Dieses Dokument gilt nicht für:
a)   IVD Geräte oder  Ausrüstungen;
b)   IVD Reagenzien für den Gebrauch durch Fachpersonal.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics (ISO/FDIS 18113-4:2022)

Le présent document spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro (DIV), d’étalons et de matériaux de contrôle destinés aux autodiagnostics.
Le présent document peut aussi s’appliquer aux accessoires.
Le présent document est applicable aux étiquettes apposées sur l’emballage externe et le contenant primaire, ainsi qu’aux notices d’utilisation.
Le présent document ne s’applique pas à ce qui suit:
a) les instruments ou les équipements de DIV;
b) les réactifs de DIV à usage professionnel.

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4. del: Diagnostični reagenti in vitro za samopreskušanje (ISO/FDIS 18113-4:2022)

General Information

Status
Not Published
Publication Date
01-Dec-2022
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140 - In vitro diagnostic systems
Current Stage
6055 - CEN Ratification completed (DOR) - Publishing
Start Date
02-Oct-2022
Completion Date
02-Oct-2022
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
kSIST FprEN ISO 18113-4:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)

Relations

Revises
EN ISO 18113-4:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Effective Date
19-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 18113-4:2021
01-oktober-2021
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 4.
del: Diagnostični reagenti in vitro za samopreskušanje (ISO/DIS 18113-4:2021)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4:
Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO/DIS
18113-4:2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 4: Réactifs de diagnostic in vitro pour auto-tests (ISO/DIS 18113-
4:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-4
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-4:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 18113-4:2021

---------------------- Page: 2 ----------------------
oSIST prEN ISO 18113-4:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-4
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-02 2021-10-25
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 4:
In vitro diagnostic reagents for self-testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) —
Partie 4: Réactifs de diagnostic in vitro pour auto-tests
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 18113-4:2021(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 2021

---------------------- Page: 3 ----------------------
oSIST prEN ISO 18113-4:2021
ISO/DIS 18113-4:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 18113-4:2021
ISO/DIS 18113-4:2021(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 1
4.1 Essential requirements . 1
4.2 Ide
...

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