BS EN ISO 15194-2009 体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求

标准号：BS EN ISO 15194-2009
中文标准名称：体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求
英文标准名称：In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
标准类型：C38
发布日期：2009/5/31 12:00:00
实施日期：2009/5/31 12:00:00
中国标准分类号：C38
国际标准分类号：11.100.10
引用标准：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
适用范围：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.