5. 3D printed medical products

3D printing in the medical field is a multidisciplinary technology that involves the parallel action of two players, the medical profession (notably radiologists and surgeons) and industry.

3D printing enables personalized medicine based on anatomical data acquired and interpreted by radiologists. Radiologists are directly responsible for the correct acquisition and interpretation of medical images, which are then used to generate 3D printed models. As surgeons make increasing use of additive technologies for pre-operative planning in particular, radiologists have the opportunity to acquire a central role in this field, being able to participate more directly in the planning of the operation

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3D printed medical products

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page Application of 3D printing in medical practice

Regulatory context

Bibliography

(1) - HORN (T.J.), HARRYSSON (O.L.A.) - Overview of current additive manufacturing technologies and selected applications. - Science Progress (2012).
(2) - BARCLIFT (M.W.), WILLIAMS (C.B.) - Examining variability in the mechanical...

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)