生物技术 生物样品光度测定方法中光信号测量的最低要求

[中文适用范围]： 本文件规定了用于定性或定量表征生物样本的光度法中光信号的精确测量的最低要求。本文件适用于由生物发光、化学发光和荧光等产生的光信号，以及由于吸收而检测到的光变化的光信号。本文件涉及用于测量生物样本的光度法中使用的光信号测量仪器的验证，包括使用光学参考的考虑因素。本文件不提供用于测量生物样本的工作流程的行业或应用特定性能标准。在适用的情况下，用户还可以查阅现有的行业或应用特定标准，或两者兼而有之。 [外文原描述]： This document specifies minimum requirements to support accurate measurement of optical signals in photometric methods used for qualitative or quantitative characterization of biological samples. This document is applicable to optical signals that are generated, for example, by bioluminescence, chemiluminescence and fluorescence, and optical signals that are detected as changes of light due to absorption. This document addresses the verification of optical signal measurement instruments used in photometric methods for measurement of biological samples including considerations for the use of optical references. This document does not provide sector- or application-specific performance criteria for the workflow of measuring biological samples. When applicable, users can also consult existing sector- or application- specific standards, or both.