ISO/TC 212
Medical laboratories and in vitro diagnostic systems

Standardization and guidance in the field of medical laboratories and in vitro diagnostic systems. This includes, for example, quality management, pre- and postanalytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.


  • generic quality management standards dealt with by ISO/TC 176;
  • quality management standards for medical devices dealt with by ISO/TC 210;
  • reference materials guidelines dealt with by ISO/TC 334 the Committee on Reference Materials (REMCO);
  • conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).

National mirror committee of ISO/TC 212

Committee ID Name
NA 176 BR Steering Committee of DIN Standards Committee Health Technologies