ISO/FDIS 23494-1

Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements

Apstrakt

This document specifies a general concept for a provenance information model for biological material and data, 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:
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 medical diagnosis and therapy.
NOTE       International, national, or regional regulations or requirements can also apply to specific topics covered in this document.