ISO/AWI 25772

A working group has prepared a draft.

Abstract

This document specifies the quality assessment criteria and methods for human intestinal organoids (hIOs), derived from pluripotent stem cells (PSCs) and tissue-derived stem cells (TSCs), to ensure their consistency and reliability in research and non-clinical applications. It provides standardized guidelines for evaluating critical quality attributes (CQAs), including structural fidelity, functional relevance, genetic stability, and reproducibility. The document aims to support the use of hIOs in drug screening, disease modeling, and preclinical research by providing a comprehensive framework for assessing their quality and suitability for various life sciences applications. This document does not apply to hIOs intended for in vivo human application, clinical use, or therapeutic purposes, as such applications require additional regulatory compliance beyond the scope of this document.