DIN Standards Committee Health Technologies
DIN EN ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests (ISO 5649:2024); German version EN ISO 5649:2024
Medizinische Laboratorien - Konzepte und Spezifikationen für den Entwurf, die Entwicklung, die Herstellung und den Einsatz laborentwickelter Tests (ISO 5649:2024); Deutsche Fassung EN ISO 5649:2024
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
Responsible international committee
ISO/TC 212/WG 1 - Quality and competence in the medical laboratory