ISO/FDIS 23494-2

Biotechnology — Provenance information model for biological material and data — Part 2: Common provenance model

Scope

This document specifies a common model for generating, maintaining, and provisioning provenance information on biological material and data. Provenance information on biological material and data covers the entire life cycle of biological material, from collection and processing to analysis and data generation. Data provenance includes any kind of data processing and analysis.

This document also specifies requirements for provenance information serialization to achieve its interoperability.

This document is applicable to all steps of the biological material life cycle, from collection to analysis, any data generated or collected during the life cycle of the biological material, data obtained from analytical procedures applied to the biological material, and results obtained by processing and analyzing the data.

This document is applicable to organizations, authorities, and industries (a) collecting, processing, or distributing biological material and data; (b) generating, collecting, analyzing, or storing data on biological material; (c) manufacturing devices or software for the aforementioned tasks or providing facilities for these tasks.

This document establishes a horizontal standard stipulating a general guideline for provenance information management in biotechnology.

This standard provides a common model for provenance information of biological material and data for activities in life science including biotechnology and biomedicine. Although primarily intended for such applications, this standard may be used in other fields where desired.