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EN ISO 18113-2:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) EN ISO 18113-2:2011

Publication date:   Feb 17, 2012

General information

60.60 Standard published   Oct 19, 2011

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

Buying

Published

Language in which you want to receive the document.

Scope

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 18113-2:2009

NOW

PUBLISHED
EN ISO 18113-2:2011
60.60 Standard published
Oct 19, 2011

REVISED BY

IN_DEVELOPMENT
FprEN ISO 18113-2

Relations

Adopted from ISO 18113-2:2009 IDENTICAL