STANDARD

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ÖNORM EN ISO 18113-4

Issue date: 2024 10 01

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

General information on ÖNORM EN ISO 18113-4

Format
Paper | 24 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 18113-4 from 1993 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 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
Dokumentnummer
ISO 18113-1:2009
Titel
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
Ausgabedatum
2009 12 09
Art
Standard

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