FprEN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO/FDIS 18113-1:2022)

In diesem Dokument werden Konzepte definiert, allgemeine Prinzipien aufgestellt und wesentliche Anforderungen an die durch den Hersteller von In vitro-Diagnostika bereitgestellten Informationen festgelegt.
Dieses Dokument enthält keine Festlegungen zu sprachlichen Anforderungen, da diese in den Bereich nationaler Gesetze und Vorschriften fallen.
Dieses Dokument gilt nicht für
a)   In vitro-Diagnostika zur Leistungsbewertung (z. B. nur für Forschungszwecke),
b)   Versanddokumente,
c)   Datenblätter zur Materialsicherheit,
d)   Marketing-Informationen (in Übereinstimmung mit den geltenden rechtlichen Anforderungen).

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO/FDIS 18113-1:2022)

Le présent document définit les concepts, établit les principes généraux et spécifie les exigences essentielles relatives aux informations fournies par le fabricant de dispositifs médicaux de DIV.
Le présent document ne traite pas des exigences relatives à la langue, car ces dernières relèvent du domaine des législations et réglementations nationales.
Le présent document ne s’applique pas à ce qui suit :
a) dispositifs médicaux de DIV utilisés pour l’évaluation des performances (par exemple pour un usage expérimental uniquement) ;
b) documents d’expédition ;
c) fiches de données de sécurité / fiches signalétiques des matériaux ;
d) informations marketing (conformément aux exigences légales applicables).

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 1. del: Izrazi, definicije in splošne zahteve (ISO/FDIS 18113-1:2022)

General Information

• Status: Not Published
• Publication Date: 01-Dec-2022
• ICS: 01.040.11 - Health care technology (Vocabularies)
• 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 18113-1:2022 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)

Relations

• Revises: EN ISO 18113-1:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 18113-1:2021
01-oktober-2021
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 1.
del: Izrazi, definicije in splošne zahteve (ISO/DIS 18113-1:2021)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1:
Begriffe und allgemeine Anforderungen (ISO/DIS 18113-1:2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO/DIS 18113-
1:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-1
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 18113-1:2021

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oSIST prEN ISO 18113-1:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-1
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 1:
Terms, definitions, and general requirements
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 18113-1:2021(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

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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(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
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Phone: [phone]
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Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for information supplied by the manufacturer.22
4.1 General .22
4.2 Language .23
4.3 Symbols and ide
...