本文件旨在协助设计和组织生物试验验证试验。描述了标准化过程不同步骤中的验证活动。本文件包括总体数据评估和后续验证研究结论。 本文件旨在验证其实验设计和终点可能不同的生物试验。本文件的某些要求可能不适用于所有测试方法。

This document aims to assist in designing and organizing trials for validation of biotests. The validation activities during the different steps of the standardization process are described. This document comprises the overall data evaluation and subsequent validation study conclusion. This document is intended for the validation of biotests which can differ in their experimental design and endpoints. It is possible that some of the requirements of this document are not applicable to all test methods.