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
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Legislation related to this standard
WITHDRAWN
EN 376:2002
WITHDRAWN
EN ISO 18113-4:2009
99.60
Withdrawal effective
Oct 19, 2011
WITHDRAWN
EN ISO 18113-4:2011