DIN EN ISO 15193-2009
体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO 15193:2009),DIN EN ISO 15193:2009-10的英文版本

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10

DIN EN ISO 15193-2009 发布历史

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, "international measurement standard" designates a material standard. The term "international standard" is used by WHO for reference materials.

DIN EN ISO 15193-2009由德国标准化学会 DE-DIN 发布于 2009-10。

DIN EN ISO 15193-2009 在中国标准分类中归属于: C38 普通诊察器械。

DIN EN ISO 15193-2009 发布之时，引用了标准

• ISO 15194 体外诊断医疗设备.生物原始试样数量测量.认证参考材料和证明文件的内容要求
• 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)

DIN EN ISO 15193-2009的历代版本如下：

• 2009年10月 DIN EN ISO 15193-2009 体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO 15193:2009),DIN EN ISO 15193:2009-10的英文版本

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标准号

DIN EN ISO 15193-2009

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 15194 ISO/IEC GUIDE 99-2007 ISO/IEC GUIDE 98-3-2008

被代替标准

DIN EN 12286-1999 DIN EN 12286 Berichtigung 1-2000 DIN EN ISO 15193-2006

适用范围

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, "international measurement standard" designates a material standard. The term "international standard" is used by WHO for reference materials.