STANDARD

Current

ÖNORM EN ISO 18113-1

Issue date: 2024 10 01

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

General information on ÖNORM EN ISO 18113-1

Format
Paper | 73 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 18113-1 from 2010 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 13485:2016
Titel
Medical devices — Quality management systems — Requirements for regulatory purposes
Ausgabedatum
2016 02 25
Art
Standard
Dokumentnummer
ISO 14971:2019
Titel
Medical devices — Application of risk management to medical devices
Ausgabedatum
2019 12 10
Art
Standard
Dokumentnummer
ISO 15223-1:2021
Titel
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)
Ausgabedatum
2021 07 06
Art
Standard

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