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prSSH EN ISO 18113-5:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

General information

40.20     Feb 10, 2025

40.60    May 6, 2025

DPS

DPS/KT 140

European Norm

11.100.10  

Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.

Related directives

Directives related to this standards.

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

Directive 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 18113-5:2011

NOW

IN_DEVELOPMENT
prSSH EN ISO 18113-5:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN ISO 18113-5:2024 IDENTICAL

Adopted from ISO 18113-5:2022 IDENTICAL

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