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

DIN EN ISO 15194-2009 发布历史

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.

DIN EN ISO 15194-2009由德国标准化学会 DE-DIN 发布于 2009-10。

DIN EN ISO 15194-2009 在中国标准分类中归属于: C38 普通诊察器械。

DIN EN ISO 15194-2009 发布之时，引用了标准

• ISO 31 量和单位.第9部分:原子和核物理
• ISO 13485 医疗器械.质量管理体系.管理用途的要求*， 2016-03-01 更新
• ISO 5725-2 ISO 5725-2-2019
• ISO 17511-2003 体外诊断医疗装置.生物试样的定量测量.校准仪和控制材料赋值的计量溯源性
• ISO 18153 体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料所赋酶的催化浓度值的计量溯源性
• ISO GUIDE 31 基准材料. 证书, 标签和随附文档的内容
• ISO GUIDE 34 参考材料生产商权限的一般要求
• ISO GUIDE 35 ISO Guide 35-2017
• ISO/IEC GUIDE 99-2007 计量学的国际词汇.基本与一般概念与相关术语(VIM)
• ISO/IEC GUIDE 98-3-2008 测量的不确定性.第3部分:测量不确定性的表达指南(GUM-1995)

* 在 DIN EN ISO 15194-2009 发布之后有更新，请注意新发布标准的变化。

DIN EN ISO 15194-2009的历代版本如下：

• 2009年10月 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

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标准号

DIN EN ISO 15194-2009

发布日期

2009年10月

实施日期

废止日期

无

中国标准分类号

C38

国际标准分类号

11.100.10

发布单位

DE-DIN

引用标准

ISO 31 ISO 13485 ISO 5725-2 ISO 17511-2003 ISO 18153 ISO GUIDE 31 ISO GUIDE 34 ISO GUIDE 35 ISO/IEC GUIDE 99-2007 ISO/IEC GUIDE 98-3-2008

被代替标准

DIN EN 12287-1999 DIN EN ISO 15194-2007

适用范围

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.

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