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DS/EN ISO 15194

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation

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Organization: DS
Publication Date: 11 June 2009
Status: active
Page Count: 25
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation for them to be considered as higher order according to ISO 17511. It is applicable to reference materials classifiable as primary measurement standards, secondary measurement standards, [RD] and international conventional calibrators that function either as calibrators or trueness control materials. [RD What about precision control materials, cf. 4.5]This International Standard also provides requirements on how data shall be collected for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to reference materials with assigned values of differential or rational quantities. For nominal properties and ordinal quantities, see Annex A. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although many elements may be helpful.

Document History

DS/EN ISO 15194
June 11, 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
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation for them to be considered as higher order according to ISO...
In vitro diagnostic medical devices – Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
This standard specifies requirements for producers of CRMs of higher metrological order and the content of their supporting documentation that comply with the requirements of ISO 17511 and the...
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/DIS 15194:2007)
This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary...
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/FDIS 15194:2009)
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...

References

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