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.
Document identifier
ISO 18113-1:2009
Title
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO Category
TC 212: Clinical laboratory testing and in vitro diagnostic test systems
Publication date
2009-12-15
Status
Effective
International Relationship
BS EN ISO 18113-1:2009 * DIN EN ISO 18113-1 * BS EN ISO 18113-1:2011 * DIN EN ISO 18113-1