DIN Standards Committee Health Technologies
DIN EN ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2022); Deutsche Fassung EN ISO 18113-1:2024
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices