ISO/TS 20388:2021 生物技术 生物银行 动物生物材料的要求

标准编号：ISO/TS 20388:2021

中文名称：生物技术 生物银行 动物生物材料的要求

英文名称：Biotechnology — Biobanking — Requirements for animal biological material

发布日期：2021-12

标准范围

本文件规定了从动物（不包括人类）获取的生物材料的收集、接收、准备、保存、运输、储存、分配、销毁和处置要求。这些资源包括固体组织、液体样本和相关细胞、排泄物和相关数据。本文件适用于可用于研究和开发的生物材料或相关数据，或同时适用于从生物材料衍生的生物分子，例如核酸、蛋白质和代谢物。本文件适用于开展生物银行研究和开发的所有组织。本文件不适用于拟用于食品或饲料生产的生物材料、进行食品或饲料生产分析的实验室、或用于治疗的实验室或多个实验室。本文件不适用于来源于动物生物材料的细胞系的建立。注:国际、国家或地区法规或要求，或其中的多项法规或要求，也可适用于本文件所涵盖的特定主题。

This document specifies requirements for the collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of biological materials obtained from animals, excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory products and associated data.This document is applicable to biological material or associated data, or both, that can be used for research and development and to biomolecules derived from the biological material, e.g. nucleic acids, proteins and metabolites.This document is applicable to all organizations performing biobanking for research and development.This document does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or therapeutic use, or multiple of them.This document does not apply to the establishment of cell lines derived from animal biological material.NOTE      International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

标准预览图