本文件就如何实施ISO 20387的质量管理、管理和技术要求向生物银行提供指导。它扩展了ISO 20387的各个方面，并提供了示例以供说明。本文件的目的是帮助生物银行解决人员能力、生物材料和数据收集的适当质量问题。本文件同样适用于新建立的和现有的生物库。 本文件适用于所有执行生物库的组织，包括多细胞生物（如人类、动物、真菌和植物）和微生物生物材料的生物库，用于研究和开发。 本文件不适用于用于饲料/食品生产的生物材料、用于食品/饲料生产和/或治疗用途分析的实验室。

This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g., human, animal, fungus and plant) and microorganisms for research and development. This document does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production and/or therapeutic use.