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ISO/CD TS 25812

Biotechnology — General requirements for performance evaluation of hydrogel materials used in bio-device fabrication

General information

30.20     Sep 1, 2026

ISO

ISO/TC 276

Technical Specification

Scope

This document gives requirements for hydrogel materials used in bio-device fabrication for in vitro studies and applications.
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.

Life cycle

NOW

PROJECT
ISO/CD TS 25812
30.20 CD study/ballot initiated
Sep 1, 2026

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