本文档指定了用于生成、维护和提供对象（如生物材料和数据）的来源信息的通用模型。本文件还规定了出处信息序列化的要求，以实现其互操作性。来源信息涵盖与生物材料的可追溯性、质量和用途适用性相关的任何信息，以及在生物材料从收集到分析的整个生命周期中生成的数据，包括源自应用于生物材料的分析程序的数据和数据的进一步处理。 本文件适用于以下组织、机构和行业: 获取、收集、处理、测试、分析、储存或分发生物技术和生物医学中的生物材料（例如。g.、生物库、实验室、生物医学研究以及生物技术开发或生产)； 生成、收集、分析、处理或存储关于生物材料和与生物材料相关的数据(例如，生物库、实验室、开发商、制造商或生物技术或生物医学中的其他机构和商业组织)； 生成、收集、分析、处理或存储生物技术和生物医学中的数据或数字对象(例如，体外/体内/计算机诊断开发商和制造商，或该领域中的其他机构和商业组织)； )制造用于上述任务的设备或软件或为这些任务提供设施。 本文件也适用于与出处信息管理相关的服务提供商（例如。g.、出处信息生成、存储、提供或验证)。 客户、监管机构、使用同行评估的组织和计划、认证机构和其他人可以使用本文件来确认或认可上述各方的能力。 本文件不适用于用于医学诊断和治疗的生物材料和数据。 注1本文件可适用于从事实验室或研究活动以及生物技术和生物医学领域其他活动的组织。 注2国际、国家或地区法规、标准或要求可适用于本文件涵盖的特定主题，例如，适用于处理为诊断和治疗目的采购和使用的人体材料的组织。

This document specifies a common model for generating, maintaining, and provisioning provenance information on objects, such as biological material and data. This document also specifies requirements for provenance information serialization to achieve its interoperability. 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:

1.  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);
2. 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);
3. 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);
4. )manufacturing devices or software for the afore mentioned 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).

Customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in confirming or recognizing the competence of the aforementioned parties.

This document does not apply to biological material and data used for medical diagnosis 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.