本文件规定了生物库能力、公正性和一致性操作的一般要求，包括确保生物材料和数据收集具有适当质量的质量控制要求。 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。 生物银行用户、监管机构、使用同行评估的组织和方案、认证机构和其他机构也可以使用本文件确认或认可生物银行的能力。 本文件不适用于用于食品/饲料生产的生物材料、用于食品/饲料生产分析的实验室和/或治疗用途。 注1:国际、国家或地区法规或要求也可适用于本文件涵盖的特定主题。 注2:对于处理为诊断和治疗目的采购和使用的人体材料的实体，ISO 15189和其他临床标准将首先适用。

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. 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. Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use. NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.