标准编号：ISO 21899:2020
中文名称：生物技术 生物库 生物库中生物材料加工方法的验证和验证的一般要求
英文名称：Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
发布日期：2020-06
标准范围
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.
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