ISO/WD 25693

Biotechnology-- Developing process of Organ-on-Chip used for the evaluation of substances

Scope

This document specifies requirements related to the development process of Organ-on-Chip (OoC) to ensure the fitness for purpose for the evaluation of substances under specific conditions. This document is applicable to suppliers and users of OoC, as well as suppliers of cells and devices that constitute to a OoC in the development process. This document is applicable to evaluate any types of substances such as chemicals, biologics, cellular therapeutic products and pharmaceuticals based on context of use.