ISO/WD 25591

A working group has prepared a draft.

Abstract

This document provides a standardised framework for data and metadata requirements that ensures FAIR(Findable-Accessible Interoperable-Reusable) and regulatory-ready data from organ-on-chip (OoC) and microphysiological systems (MPS) for definition, creation and the usage in digital twin and computational modelling technologies. The document also provides recommendations and requirements for experimental design supporting reproduciblity of OoC and MPS. It covers: (1) experimental design and data outputs, (2) device- and assay-level metadata necessary to interpret those outputs, and (3) linkages to computational tools and modeling, including provenance and versioning.

This document is applicable to all parties involved in the research, development, regulation, and application of MPS and OoC technologies. These include, but are not limited to, academic and research institutions, biotechnology and pharmaceutical companies, chemical and cosmetics manufacturers, regulatory agencies, contract research organizations, healthcare providers, and funding bodies.