ISO/WD TS 25812

Biotechnology — Performance evaluation guidelines for hydrogel materials used in bio-device fabrication

Scope

This document gives requirements for hydrogel materials used in bio-device fabrication.
This document specifies the evaluation index and the method for assessing the quality and functionality of hydrogel materials.
This document is applicable to the design, production, and quality control of hydrogel-based biodevices.
This document is intended to be used by bioink manufacturers, bio-device developers, research institutions, and regulatory bodies involved in hydrogel-based bio-device development.