标准摘要
[中文适用范围]: 本文件规定了用于实验室医学的被测量的参考测量程序的要求。本文件适用于:a) 提供差值量或比率量值的参考测量程序,其中每个量值是一个数值乘以一个测量单位。附录A提供了关于有序量和名义性质的信息;b) 任何为实验室医学使用的被测量开发参考测量程序的个人、机构或组织。 [外文原描述]: This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. This document applies to: RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties; any person, body or institution developing RMPs for measurands used in laboratory medicine.
英文名称In vitro diagnostic medical devices — Requirements for reference measurement procedures