DIN Standards Committee Health Technologies
DIN EN ISO 15194
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2026); German version EN ISO 15194:2026
In-vitro-Diagnostika - Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der Begleitdokumentation (ISO 15194:2026); Deutsche Fassung EN ISO 15194:2026
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory