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.
PROJECT
ISO/FDIS 24031
50.20
Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 2, 2026
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