- Standard No.
- EN ISO 15194:2009
- Release Date
- 2009
- Published By
- European Committee for Standardization (CEN)
- Latest
-
EN ISO 15194:2009
- Replace
-
BS EN 12287:1999
- Scope
- This International Standard specifies requirements for certified reference materials and the content of theirsupporting documentation, in order for them to be considered of higher metrological order in accordance withISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards,secondary measurement standards and international conventional calibrators that function either ascalibrators or trueness control materials.This International Standard also provides requirements on how tocollect data for value determination and how to present the assigned value and its measurement uncertainty.
EN 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 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)
EN ISO 15194:2009 history
- 2009 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
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 has been changed from BS EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials.