生物技术.生物库.生物库的一般要求

[中文适用范围]： 本文件规定了生物样本库的能力、公正性和一致运营的一般要求，包括质量控制要求，以确保生物材料和数据收集具有适当的质量。 本文件适用于所有进行生物样本库的组织，包括来自多细胞生物体（例如人类、动物、真菌和植物）和用于研究和开发的微生物的生物材料的生物样本库。 生物样本库用户、监管机构、使用同行评估、认证机构的组织和计划以及其他机构也可以使用本文件来确认或认可生物样本库的能力。 本文件不适用于用于食品/饲料生产的生物材料、进行食品/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适用于本文件涵盖的特定主题。 注 2：对于处理采购并用于诊断和治疗目的的人体材料的实体 [外文原描述]： 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.