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SSH EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

Mar 29, 2012

General information

60.60     Mar 29, 2012

DPS

DPS/KT 140

European Norm

11.100.10  

English  

Buying

Published

Language in which you want to receive the document.

Scope

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.

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WITHDRAWN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 591:2006

NOW

PUBLISHED
SSH EN ISO 18113-3:2011
60.60 Standard published
Mar 29, 2012

REVISED BY

IN_DEVELOPMENT
prSSH EN ISO 18113-3:2024

Related project

Adopted from EN ISO 18113-3:2011