ISO/AWI 25530

Projet

Rédaction en cours.

Résumé

This document gives quality control requirements and documentation requirements for biological components to be integrated in microphysiological system (MPS) and Organ-on-Chip (OoC) experiments. This document specifies criteria regarding cell type (primary cells, pluripotent stem cells, cell lines), cell/tissue isolation conditions, cell sources (commercial, patient-derived, biobanks etc.), species, and covers quality control analysis (karyotyping, phenotyping, mycoplasma testing). This document is applicable to MPS and OoC developers and users.