FAIRsharing record for: ISO 20387:2018 Biotechnology — Biobanking — General requirements for biobanking

This FAIRsharing record describes: 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. ISO 20387:2018 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.

本FAIRsharing记录描述如下：本文件规定了生物样本库（biobanks）在能力资质、公正性与运营一致性方面的通用要求，其中包含用于保障生物材料与数据集合符合合格质量标准的质量控制（quality control）要求。ISO 20387:2018 适用于所有开展生物样本库业务的机构，包括为研发目的收集多细胞生物（如人类、动物、真菌与植物）及微生物的生物材料的相关活动。生物样本库使用者、监管机构、采用同行评估机制的组织与计划、认可机构及其他相关方，也可借助本文件确认或认可生物样本库的能力资质。本文件不适用于用于食品/饲料生产的生物材料、为食品/饲料生产开展分析检测的实验室，以及用于治疗用途的相关场景。