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
Product Details
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 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.