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 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.


General Information

Status Current
Edition 2009
No. of Pages 49
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee ISO/TC 212
Available for Purchase For sale in Singapore only
Adoption ISO