8. Glossary

510(k); 510(k) (Premarket Notification)

Procedure requested by the FDA for marketing low-risk (Class I) devices in the United States. The 510(k) corresponds to the marketing of the device in accordance with a declaration of equivalence to a product already on the market.

Shape memory alloys ; Alliages à mémoire de forme

Materials capable of recovering their original shape when subjected to a thermomechanical loop, allowing the transition from an austenitic state (stable phase at high temperature) to a martensitic state (stable phase at low temperature). If the alloy is deformed by mechanical stress at low temperature, it will regain its initial shape simply by heating. Shape memory alloys also feature superelastic properties, enabling the material to deform reversibly by up to 8% under mechanical stress.