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SSH EN ISO 18113-5:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Mar 29, 2012

General information

60.60     Mar 29, 2012

DPS

DPS/KT 140

European Norm

11.100.10  

English  

Buying

Published

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Scope

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 592:2004

NOW

PUBLISHED
SSH EN ISO 18113-5:2011
60.60 Standard published
Mar 29, 2012

REVISED BY

IN_DEVELOPMENT
prSSH EN ISO 18113-5:2024

Related project

Adopted from EN ISO 18113-5:2011