Clinical laboratory testing and in vitro diagnostic test systems
Scope LV
Not set
Scope EN
<html><head></head><body>Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance. <P>Excluded: <UL> <LI>generic quality management standards dealt with by ISO / TC 176; <LI>quality management standards for medical devices dealt with by ISO / TC 210; <LI>reference materials guidelines dealt with by the ISO Committee on Reference Materials (REMCO); <LI>conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO). </UL> </body></html>