ISO 15193:2009 体外诊断医疗器械 生物源性样品中量的测量 基准测量程序的内容和表示要求

标准编号：ISO 15193:2009

中文名称：体外诊断医疗器械 生物源性样品中量的测量 基准测量程序的内容和表示要求

英文名称：In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures

发布日期：2009-05

标准范围

ISO 15193:2009规定了体外诊断医疗设备和医疗实验室参考测量程序的内容要求。ISO 15193:2009适用于提供微分或合理量值的参考测量程序。附录A提供了有关标称特性和序数的信息。ISO 15193:2009适用于实验室医学各个分支之一的任何个人、机构或机构，其目的是编写一份文件作为参考测量程序。

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.ISO 15193:2009 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.

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