DIN EN ISO 15194:2009 PDF

Scope: 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 International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard 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.

DIN EN ISO 15194:2009 Referenced Document

ISO 13485 *， 2018-05-15 Update
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 31 Quantities and units — Part 9: Atomic and nuclear physics — Amendment 1
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)

2024 DIN EN ISO 15194:2024-02 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023 / Note: Date of issue 2024-01-05*Intended as replaceme...
2009 DIN EN ISO 15194:2009-10 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); German version EN ISO 15194:2009
2009 DIN EN 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 (ISO 15194:2009); English version of DIN EN ISO 15194:2009-10
0000 DIN EN ISO 15194:2007
0000 DIN EN 12287:1999