0

ISO 18113-5:2022

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

Publication date:   Oct 6, 2022

General information

60.60 Standard published   Oct 6, 2022

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.10   In vitro diagnostic test systems

Buying

Published

Language in which you want to receive the document.

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

PREVIOUSLY

WITHDRAWN
ISO 18113-5:2009

NOW

PUBLISHED
ISO 18113-5:2022
60.60 Standard published
Oct 6, 2022