ISO/WD 24031

Biotechnology — General requirements for nucleic acid- and protein-based bio-devices

Scope

This document provides terminology and definitions in the field of nucleic acid- and protein-based devices.
This document specifies general requirements for the design, development, amplification, evaluation and production of nucleic acid- and protein-based devices.
This document specifies the requirements for natural and modified biological material used in nucleic acid- and protein-based devices.
This document does not apply to medical devices or medical products.