ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Bereitstellung von Informationen durch den Hersteller - Teil 1: Terminologie und allgemeine Anforderungen
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible international committee
ISO/TC 212 - Medical laboratories and in vitro diagnostic systems