EN ISO 18113-2:2009

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

Publication date:   Mar 22, 2010

General information

99.60 Withdrawal effective   Oct 19, 2011

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

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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
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN 375:2001

NOW

WITHDRAWN
EN ISO 18113-2:2009
99.60 Withdrawal effective
Oct 19, 2011

REVISED BY

WITHDRAWN
EN ISO 18113-2:2011