ISO/NP 26835-2

Biotechnology — Drug toxicity testing using human organoids — Part 2: Part 2: Quality requirements for human pluripotent stem cell-derived cardiac organoids

Scope

This document specifies general requirements and considerations for the production, culture, characterization, and quality control of human pluripotent stem cell (hPSC)-derived cardiac organoids (hCOs) intended for use in toxicity research and development, including:
a) requirements for source hPSCs and manufacturing processes;
b) specifications for cardiac organoid differentiation, maturity, and functionality;
c) characterization methods for identity, purity, and functional competence;
d) quality control criteria for use in specific toxicity applications.
This document does not apply to cardiac organoids intended for clinical therapy or transplantation.