标准摘要
[中文适用范围]： 本文件规定了用于生物库中生物材料储存的主容器的要求。除了通用要求外，本文件还根据储存条件、生物材料种类及预期用途，以及文件记录和质量控制的要求，制定了特定要求。这些要求为确保主容器满足必要的质量标准提供了框架。本文件规定了测试标准和测试方法，以证明符合相关要求。本文件主要面向生产用于储存生物材料主容器的制造商。生物库、生物材料提交者、使用者以及监督或管理生物库工作的组织也可使用本文件。注：用于治疗用途的生物材料主容器可能适用其他要求。 [外文原描述]： This document specifies requirements for primary containers intended for the storage of biological materials in biobanks. In addition to general requirements, this document also specifies special requirements depending on the storage conditions, the biological material and the intended use, as well as requirements for documentation and quality control. These requirements establish the framework for ensuring that primary containers meet the necessary quality criteria. This document specifies test criteria and test methods that enable proof of conformity with the requirements. This document is primarily aimed at manufacturers that produce primary containers for the storage of biological materials. Biobanks, submitters and users of biological material, and organizations that monitor or control the work of biobanks can also use this document. NOTE For primary containers intended for biological material for therapeutic use, other requirements can apply.
英文名称Biotechnology — Biobanking — Requirements for primary containers for storing biological materials in biobanks