This document defines terms, gives guidance for classification and establishes requirements for nucleic acid- and protein-based bio-devices.
This document is applicable to bio-devices incorporating natural, modified and synthetically derived nucleic acid and/or protein.
This document does not apply to medical devices or products.
IN_DEVELOPMENT
ISO/FDIS 24031
50.00
Final text received or FDIS registered for formal approval
18 qer 2026