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EN ISO 18113-1:2009

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

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

Buying

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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 legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
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

Legislation 2007/47/EC

Life cycle

NOW

WITHDRAWN
EN ISO 18113-1:2009
99.60 Withdrawal effective
Oct 19, 2011

REVISED BY

WITHDRAWN
EN ISO 18113-1:2011