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
Withdrawn
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.
Legislation related to this standard
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
WITHDRAWN
EN 375:2001
WITHDRAWN
EN ISO 18113-2:2009
99.60
Withdrawal effective
Oct 19, 2011
WITHDRAWN
EN ISO 18113-2:2011
