A novel approach for increasing the traceability of 3D printed medical products

According to the European Medical Device Directive (MDR (EU) 2017/745), medical products of all risk classes are obliged to be labelled with Unique Device Identification Codes (UDI). In order to meet the requirements of the MDR, a novel method of identification for additively manufactured metallic p...

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Autores principales:	Matvieieva Nataliia, Neupetsch Constanze, Oettel Markus, Makdani Varun, Drossel Welf- Guntram
Formato:	article
Lenguaje:	EN
Publicado:	De Gruyter 2020
Materias:	mdr component identification traceability barcode laser beam melting powder bed fusion Medicine R
Acceso en línea:	https://doaj.org/article/64e292386f3c4cdca2278e9361b36302
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id	oai:doaj.org-article:64e292386f3c4cdca2278e9361b36302
record_format	dspace
spelling	oai:doaj.org-article:64e292386f3c4cdca2278e9361b363022021-12-05T14:10:42ZA novel approach for increasing the traceability of 3D printed medical products2364-550410.1515/cdbme-2020-3081https://doaj.org/article/64e292386f3c4cdca2278e9361b363022020-09-01T00:00:00Zhttps://doi.org/10.1515/cdbme-2020-3081https://doaj.org/toc/2364-5504According to the European Medical Device Directive (MDR (EU) 2017/745), medical products of all risk classes are obliged to be labelled with Unique Device Identification Codes (UDI). In order to meet the requirements of the MDR, a novel method of identification for additively manufactured metallic products was developed at the Fraunhofer Institute for Machine Tools and Forming Technology (IWU). The method provides a product traceability within its production process and during the whole product lifespan, and also functions as a counterfeit protection. This paper shows the integration of a unique identification during an additive manufacturing process for a titanium part. The readout of the integrated identification was executed using ultrasonic and eddy current methods, as well as micro computed tomography. Obtained results are discussed in the paper.Matvieieva NataliiaNeupetsch ConstanzeOettel MarkusMakdani VarunDrossel Welf- GuntramDe Gruyterarticlemdrcomponent identificationtraceabilitybarcodelaser beam meltingpowder bed fusionMedicineRENCurrent Directions in Biomedical Engineering, Vol 6, Iss 3, Pp 315-318 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	mdr component identification traceability barcode laser beam melting powder bed fusion Medicine R
spellingShingle	mdr component identification traceability barcode laser beam melting powder bed fusion Medicine R Matvieieva Nataliia Neupetsch Constanze Oettel Markus Makdani Varun Drossel Welf- Guntram A novel approach for increasing the traceability of 3D printed medical products
description	According to the European Medical Device Directive (MDR (EU) 2017/745), medical products of all risk classes are obliged to be labelled with Unique Device Identification Codes (UDI). In order to meet the requirements of the MDR, a novel method of identification for additively manufactured metallic products was developed at the Fraunhofer Institute for Machine Tools and Forming Technology (IWU). The method provides a product traceability within its production process and during the whole product lifespan, and also functions as a counterfeit protection. This paper shows the integration of a unique identification during an additive manufacturing process for a titanium part. The readout of the integrated identification was executed using ultrasonic and eddy current methods, as well as micro computed tomography. Obtained results are discussed in the paper.
format	article
author	Matvieieva Nataliia Neupetsch Constanze Oettel Markus Makdani Varun Drossel Welf- Guntram
author_facet	Matvieieva Nataliia Neupetsch Constanze Oettel Markus Makdani Varun Drossel Welf- Guntram
author_sort	Matvieieva Nataliia
title	A novel approach for increasing the traceability of 3D printed medical products
title_short	A novel approach for increasing the traceability of 3D printed medical products
title_full	A novel approach for increasing the traceability of 3D printed medical products
title_fullStr	A novel approach for increasing the traceability of 3D printed medical products
title_full_unstemmed	A novel approach for increasing the traceability of 3D printed medical products
title_sort	novel approach for increasing the traceability of 3d printed medical products
publisher	De Gruyter
publishDate	2020
url	https://doaj.org/article/64e292386f3c4cdca2278e9361b36302
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A novel approach for increasing the traceability of 3D printed medical products

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