Qualification of Customised Medical Implants Produced by Ti6Al4V(ELI) Additive Manufacturing

Abstract

Although many cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature, most of these processes had not been qualified. To enable certification and commercialisation of medical implants and devices an ISO 13485:2016 quality management system was successfully implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) at the Central University of Technology, Free State in South Africa. This certification covers qualification of both design, development and production of patient specific custom made titanium implants, as well as preoperative models, jigs and cutting guides in nylon by means of AM and supports commercialisation. With this quality management system as framework for ensuring the reliability and repeatability of the AM performed at the CRPM, the generation of data to validate the individual processes in the AM process chain was pursued. Sufficient research data has been produced and published to prove that medical implants produced through AM can fully comply with the international standards for material, physical, chemical and mechanical properties. In this paper the research performed towards the qualification of AM of Ti6Al4V medical implants is discussed. Examples are given of internationally leading work on utilising these implants in maxillofacial and orthopaedic surgeries.