ISO/CD 25693

A draft is being reviewed by the committee.

Abstract

This document specifies a framework of minimum requirements and general considerations 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 an OoC in the development process. This document is applicable to evaluate any types of substances such as chemicals, biologics, cellular therapeutic products and pharmaceuticals using OoC suitable for context of use.

NOTE Future standards can use this document as a framework when developing standards for substances and contexts of use.