ISO 15194:2009 PDF

ISO 15194:2009 Referenced Document

ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 5725-2 Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method*， 2019-12-06 Update
ISO Guide 31 Reference materials - Contents of certificates, labels and accompanying documentation*， 2015-11-01 Update
ISO Guide 34 General requirements for the competence of reference material producers
ISO Guide 35 Certification of reference materials — General and statistical principles*， 2017-08-21 Update
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

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 documentation
2002 ISO 15194:2002 In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials