標(biāo)準(zhǔn)號(hào)：BS EN ISO 15194-2009
中文標(biāo)準(zhǔn)名稱：體外診斷醫(yī)療器械.生物源樣品的數(shù)量測(cè)量.輔助文檔的認(rèn)證參考材料和內(nèi)容要求
英文標(biāo)準(zhǔn)名稱：In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
標(biāo)準(zhǔn)類型：C38
發(fā)布日期：2009/5/31 12:00:00
實(shí)施日期：2009/5/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C38
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.100.10
引用標(biāo)準(zhǔn)：ISO 31;ISO 5725-2;ISO 17511-2003;ISO 18153;ISO GUIDE 31;ISO GUIDE 34;ISO GUIDE 35;ISO/IEC GUIDE 98-3-2008;ISO/IEC GUIDE 99-2007
適用范圍：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.This International Standard applies to certified reference materials with assigned values of differential orrational 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 diagnosticmeasuring system, although it is possible that many elements are helpful.