In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

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

This international standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. 

This document is available in electronic format only. 

Member Price: as low as $43.50

Nonmember Price: $145.00
Log in to see your price and add to cart

Publication Details

Date of Publication: May 1, 2009

Order Code PDF: ISO15194E

Order Code Print: print not available

Edition: Second

Pages: 16

ISO 15194:2009 Additional Details

ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This document applies to certified reference materials with assigned values of differential or rational quantities and does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems