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Withdrawn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 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
Legislation related to this standard
In vitro diagnostic medical devices
Harmonised Standard / Cited in the Official JournalDirective 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WITHDRAWN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 ISO 18113-1:2009
99.60
Withdrawal effective
Oct 19, 2011
WITHDRAWN
EN ISO 18113-1:2011
