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SSH EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

Mar 29, 2012
95.99 Withdrawal of Standard   Jun 25, 2025

General information

95.99     Jun 25, 2025

DPS

DPS/KT 140

European Norm

11.100.10  

English  

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Scope

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC

Life cycle

NOW

WITHDRAWN
SSH EN ISO 18113-1:2011
95.99 Withdrawal of Standard
Jun 25, 2025

REVISED BY

PUBLISHED
SSH EN ISO 18113-1:2024

Related project

Adopted from EN ISO 18113-1:2011