prEN ISO 15194
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

Standard No.

prEN ISO 15194

Published By

European Committee for Standardization (CEN)

Replace

EN ISO 15194:2009

prEN ISO 15194 history

• 2009 BS EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
• 1999 BS EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials