DIN Standards Committee Health Technologies
ISO/FDIS 5649
Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
Medizinische Laboratorien – Konzepte und Spezifikationen für den Entwurf, die Entwicklung, die Herstellung und den Einsatz hauseigener In-vitro-Diagnostika (laborentwickelte Tests)
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible international committee
ISO/TC 212/WG 1 - Quality and competence in the medical laboratory