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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.
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Glossary
Bibliography
Bibliography
Standards and norms
- D11 Committee: Test Method for Rubber Property – Durometer Hardness, ASTM International - ASTM - 2017
- Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56041), ASTM International - ASTM F136-08 - 2014
- Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants...
Regulations
EU 2017/745 – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (2017)
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
3D Systems – Laser melting machines on metal powder bed http://www.3dsystems.com/
Altair – Software for numerical simulation and topological optimization (SolidThinking Inspire ® )
Statistical and economic data
Gartner Predicts 2019 https://www.gartner.com/
International Data Corporation (IDC) http://www.idc.com/
Netscribes Inc. https://www.netscribes.com/
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