ISO/WD 25530

A working group has prepared a draft.

Abstract

This document gives quality control and documentation recommendations for cellular components of microphysiological system (MPS) and Organ-on-Chip (OoC) experiments. This document gives guidance on the identification of critical quality attributes characterising cellular components integrated in MPS and OoC experiments and on the selection of analytical methods to test such critical quality attributes. This document is applicable to cellular starting materials to be integrated into MPS and OoC, as well as to cellular intermediates and final materials of MPS and OoC experiments. This document is applicable to MPS and OoC developers and users and will include specific examples, case studies, or considerations that are directly relevant to these technologies.