ISO 15194:2002

In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Description of reference materials

ISO 15194:2002 specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. ISO 15194:2002 is not applicable to reference materials that are parts of an in vitro diagnostic measuring system.

ISO 15194:2002 also provides instructions on how to collect basic data for value assignment and how to present the assigned value as well as specifies the format for a certificate.

ISO 15194:2002 is not applicable to the production of the reference materials.


General information

  • Status :  Withdrawn
    Publication date : 2002-10
  • Edition : 1
  • :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • 11.100.10
    In vitro diagnostic test systems

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

 Subscribe