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SSH ISO 18113-1:2022

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

Aug 29, 2023

General information

60.60     Aug 29, 2023

DPS

DPS/KT 140

International Standard

11.100.10  

English  

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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.

Life cycle

NOW

PUBLISHED
SSH ISO 18113-1:2022
60.60 Standard published
Aug 29, 2023

Related project

Adopted from ISO 18113-1:2022 IDENTICAL