BS EN ISO 15193-2009
体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

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标准号

BS EN ISO 15193-2009

发布日期

2009年05月31日

实施日期

2009年05月31日

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

GB-BSI

引用标准

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

被代替标准

BS EN 12286-1999

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.