Hostname: page-component-586b7cd67f-g8jcs Total loading time: 0 Render date: 2024-11-24T12:00:04.561Z Has data issue: false hasContentIssue false
  • English
  • Français

Establishing a Quality Management System for Production of Certified Customised Titanium Medical Implants through Additive Manufacturing

Published online by Cambridge University Press:  17 April 2020

W B du Preez ,
D J de Beer  and
G J Booysen
W B du Preez*
Affiliation:
Centre for Rapid Prototyping and Manufacturing, Central University of Technology, Free State, Bloemfontein, South Africa
D J de Beer
Affiliation:
Centre for Rapid Prototyping and Manufacturing, Central University of Technology, Free State, Bloemfontein, South Africa
G J Booysen
Affiliation:
Centre for Rapid Prototyping and Manufacturing, Central University of Technology, Free State, Bloemfontein, South Africa
*
*(Email: [email protected])
Get access

Abstract

Various cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature. Not all manufacturing processes used, were qualified. In striving to deliver certified AM medical implants and devices, an ISO 13485:2016 quality management system was implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) of the Central University of Technology, Free State (CUT) in Bloemfontein, South Africa. This certification is valid for design, development and production of patient-specific custom-made titanium implants, preoperative models, jigs and cutting-guides in nylon through AM, and contract-production of these products. For maintaining this quality management system, the generation of data to validate the individual processes in the AM process-chain is crucial to prove the DMLS product-quality of CRPM’s products. During the past five years, directed research data was produced and published to prove that medical implants produced through DMLS can fully comply with the accepted international standards for material, physical, chemical and mechanical properties of such parts. The paper discusses the quality management system’s establishment; materials research projects executed to generate validation data are mentioned; and examples of customised titanium implants for restoring the quality of life of patients are shown.

Keywords

additive manufacturing3D printingbiomedicalTi
Type
Articles
Information
MRS Advances , Volume 5 , Issue 26: African Materials Research Society 2019 , 2020 , pp. 1387 - 1396
Copyright
Copyright © Materials Research Society 2020

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

du Preez, W B, JOM, 71 ,655 – 661 (2019).CrossRefGoogle Scholar
de Beer, D., du Preez, W., Greyling, H., Prinsloo, F., Sciammarella, F., Trollip, N., Vermeulen, M., with contributions from Terry Wohlers, “A South African Additive Manufacturing Strategy”, Department of Science and Technology, April 2016, http://www.rapdasa.org/wp-content/uploads/2017/02/South-African-Additive-Manufacturing-Strategy. Accessed 3 April 2019.Google Scholar
South Africa Medical Devices Report, Q2, www.fitchsolutions.com (2019).Google Scholar
Bezuidenhout, L., Booysen, G. and van der Merwe, A.F.,. Emerging technologies: Commercial Readiness Index (CRI) for medical additive manufacturing (AM) (2017).Google Scholar
ARENA, “Commercial Readiness Index for Renewable Energy Sectors” (2014).Google Scholar
International Standards Organisation 14971: Medical devices – Application of risk management to medical devices. Switzerland: International Standards Organisation.(2012).Google Scholar
International Standards Organisation 13485: Medical devices – Quality management systems – requirements for regulatory purposes. Switzerland: International Standards Organisation (2016).Google Scholar
Els, J., Optimal process parameters for Direct Metal Laser Sintering of Ti64 for medical implant production, MTech Dissertation, Central University of Technology, Free State (2016).Google Scholar
Krakhmalev, P., Fredriksson, G., Yadroitsava, I., Kazantseva, N., Du Plessis, A., Yadroitsev, I., Phys. Procedia, 83 ,778-788 (2016).CrossRefGoogle Scholar
Thejane, K., Characterisation and monitoring of Ti6Al4V ELI powder used for the qualification of medical implants produced through additive manufacturing, M.Eng. dissertation, Central University of Technology, Free State (2018).Google Scholar
Moletsane, M.G., Krakhmalev, P., Kazantseva, N., Du Plessis, A., Yadroitsava, I., YadroitsevI., S. I., S.Afr. J. Ind. Eng. 27, 120 – 121 (2016).Google Scholar
Muiruri, A.M., Maringa, M., du Preez, W.B. & Masu, L.M., S. Afr. J. Ind. Eng. 29, 284 – 298 (2018).Google Scholar
Amos, Muiruri, Maringa, Maina, du Preez, Willie and Leonard, Masu, Effects of Stress-Relieving Heat Treatment on Impact Toughness of Direct Metal Laser Sintering (DMLS)-Produced Ti6Al4V (ELI) Parts, JOM, DOI 10.1007/s11837-019-03862-5 (2019).Google Scholar
Malefane, L.B., du Preez, W.B., Maringa, M. & du Plessis, A., Afr, S.. J. Ind. Eng. 29, 299 – 311 (2018).Google Scholar
Thejane, K., Chikosha, S., du Preez, W. B., S. Afr. J. Ind. Eng. 28, 161-171 (2017).Google Scholar
du Plessis, A., Sperling, P., Beerlink, A., du Preez, W.B., le Roux, S.G., MethodsX 5, 1336 – 1345 (2018).CrossRefGoogle Scholar
CRPM ISO 13485:2016 Quality Management System (in-house document), Central University of Technology, Free State (2018).Google Scholar
Yadroitsev, I., Krakhmalev, P., Yadroitsava, I. and du Plessis, A., Qualification of Ti6Al4V ELI alloy produced by laser powder bed fusion for biomedical applications, JOM, 70, 372-377 (2018).CrossRefGoogle Scholar