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

Standard Details

ISO 15194:2009 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 StandardDetails, secondary measurement StandardDetails and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.

ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

ISO 15194:2009 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.

General Information

Status : Published

Standard Type: Main

Document No: ISO 15194:2009

Document Year: 2009

Pages: 16

Edition: 2

Section Volume:
ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems

ICS:
11.100.10 In vitro diagnostic test systems

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ISO 15194:2009

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