生物技术 生物材料和数据的溯源信息模型 设计概念和通用要求

[中文适用范围]： 1 范围 本标准规定了生物样本及数据的溯源信息、组织角色和溯源信息管理的一般概念与要求。溯源信息涵盖生物样本及其数据从采集至分析全生命周期中，与可追溯性、质量及适用性相关的所有信息，包括对生物样本实施分析程序所产生的数据以及数据的进一步处理信息。 本标准适用于以下在生物技术或生物医学领域开展活动的组织、主管部门和行业：获取、采集、处理、检测、分析、存储或分发生物样本（例如生物样本库、实验室、生物医学研究活动以及生物技术开发或生产单位）；生成、采集、分析、处理或存储与生物样本相关的各类数据（例如生物样本库、实验室、开发者、制造商及其他生物医学或生物技术领域的机构与商业组织）；在生物技术或生物医学领域生成、采集、分析、处理或存储数据或数字对象（例如体外/体内/计算机模拟诊断技术的开发者与制造商，以及其他相关机构与商业组织……）。 [外文原描述]： This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: acquiring, collecting, processing, testing, analysing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); generating, collecting, analysing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); generating, collecting, analysing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain); manufacturing devices or software for the aforementioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). This document can be used by customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others for confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis, treatment and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations, standards, or requirements can apply to specific topics covered in this document, e.g., for organizations handling human materials procured and used for diagnostic and treatment purposes.