DIN EN ISO 15194-2009 医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO 15194:2009),DIN EN ISO 15194:2009-10的英文版本
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
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.