ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and human samples.
Technical Committee : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ISO 15193:2009, In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures. Geneva, Switzerland: International Organization for Standardization; 2009.
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
ISO 15195:2003, Laboratory medicine — Requirements for reference measurement laboratories.
Geneva, Switzerland: International Organization for Standardization; 2003.
ISO 15189:2012 Medical laboratories - Requirements for quality and competence.
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6:
Use in practice of accuracy values. Technical Committee : ISO/TC 69/SC 6 Measurement methods
and results. Geneva, Switzerland: International Organization for Standardization; 1994.
ISO GUIDE 35:2017 Reference materials — Guidance for characterization and assessment of
homogeneity and stability.
ISO/TS 20914:2019 Medical laboratories — Practical guidance for the estimation of measurement
ISO GUIDE 33:2015 Reference materials — Good practice in using reference materials.