This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialization.

The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data.

This document is applicable to organizations, authorities and industries that are:

a)？collecting, processing or distributing biological material for research;

b)？generating, collecting, analysing or storing data on biological material.

This document does not apply to biological material and data used for other than research or in fields that are regulated by national, regional or international laws, such as medical diagnosis and therapy or food production.

NOTE？International, national, or regional regulations or requirements can also apply to specific topics covered in this document.