prSSH ISO 18113-5:2022

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

General information

Current stage: 40.20 Effective date: Feb 3, 2023

Next stage: 40.60 Next stage date: May 3, 2023

Originator: DPS

Owner: DPS/KT 140

Type: International Standard

ICS: 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.

Life cycle

NOW

IN_DEVELOPMENT
prSSH ISO 18113-5:2022
40.20 DIS ballot initiated: 12 weeks
Feb 3, 2023

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