The International Organization for Standardization (ISO) has published standard ISO/TS 21412:2020, “Nanotechnologies — Nano-object-assembled layers for electrochemical bio-sensing applications — Specification of characteristics and measurement methods.” The standard specifies the characteristics to be measured of nano-object-assembled layers on electrodes by means of a solution process and of nano-objects constituting the layers for electrochemical applications such as nano-biosensor or diagnosis applications. It also provides measurement methods for determining the characteristics. ISO notes that the standard does not apply to:
- The requirements of nanostructures by top-down nanomanufacturing;
- The subsequent coating of materials such as biomaterials onto nano-object-assembled layers;
- Specific health and safety requirements during manufacturing;
- The experimental conditions of electrochemical sensing; and
- The packaging, labeling, expiration dates, and transport of nano-object-enhanced electrochemical electrodes.