ISO 15194:2002

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

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ISO 15194:2002 specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. ISO 15194:2002 is not applicable to reference materials that are parts of an in vitro diagnostic measuring system.
ISO 15194:2002 also provides instructions on how to collect basic data for value assignment and how to present the assigned value as well as specifies the format for a certificate.
ISO 15194:2002 is not applicable to the production of the reference materials.