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ISO 18113-1:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements ISO 18113-1:2022

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 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).
.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 18113-1:2009

NOW

PUBLISHED
ISO 18113-1:2022
60.60 Standard published
Oct 6, 2022