标准摘要
[中文适用范围]： 本文件规定了适用于生物样本库的验证和验证要求，以便能够证明其使用适合目的的经过验证和/或验证的方法进行生物材料的处理。 本文件旨在用于生物材料加工方法的实施和验证。 本文件涵盖所有生物材料生产的方法验证和验证。 本文件不适用于用于食品/饲料生产的生物材料、进行食品/饲料分析的实验室和/或治疗用途。 本文档不涉及参考材料的制作。 有关参考材料的生产要求，请参见 ISO 17034。 [外文原描述]： This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose. This document is intended for use in the implementation and validation of processing methods for biological materials. This document covers method validation and verification for the production of all biological materials. This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use. Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.
英文名称Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks