ISO 18113-1:2022

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

Publication date: Oct 6, 2022

General information

Current stage: 60.60 Effective date: Oct 6, 2022

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Languages: English French

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Status: Published

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Paper - EC$562.87

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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

Revises
ISO 18113-1:2009

NOW

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

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