This standard was last reviewed and confirmed in 2015. Therefore this version remains current.
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.
Status : PublishedPublication date : 2009-12
Edition : 1Number of pages : 49
Technical Committee:Clinical laboratory testing and in vitro diagnostic test systems
Buy this standard
A standard is reviewed every 5 years
Revisions / Corrigenda