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Sandvik AM Achieves ISO 13485:2016 Medical Certification For Its Of Titanium Powder Plant

Sandvik AM Achieves ISO 13485:2016 Medical Certification For Its Of Titanium Powder Plant

Sandvik AM Achieves Medical Certification For Its Titanium Powder Plant

Sandvik’s new powder plant in Sweden has received the ‘ISO 13485:2016’ medical certification for Osprey titanium powders, now approved for use in the additive manufacturing of medical applications. “This standard will reassure our customers that Sandvik has the necessary quality management systems in place to meet the stringent requirements of the medical industry”, says Keith Murray, VP and Head of Global Sales, Sandvik Additive Manufacturing.

Additive manufacturing (AM), also known as 3D printing, is already playing a significant role in the medical segment. With additive manufacturing, implants and prostheses can be manufactured directly from an individual patient’s anatomical data. This allows these customized products to be manufactured quickly, significantly enhancing the healing process and improving the prognosis for the patient.

“Achieving the ISO 13485:2016 medical certification will allow our medical customers to complete the necessary regulatory supplier approvals when bringing a medical application to market, utilising Osprey titanium powders from Sandvik,” says Keith Murray, VP and Head of Global Sales at Sandvik Additive Manufacturing.

The properties of the metal powders used, directly impact the reliability of the performance of the AM-process, as well as the quality and performance of the finished product. This medical certification ensures that best practices and continuous improvement techniques – including the company’s development, manufacturing, and testing capabilities – are leveraged during all stages of the powder lifecycle, resulting in a safer medical device.

Complete traceability – from titanium sponge to finished powder

Product traceability is especially important in the medical industry. Sandvik offers a complete traceability for its titanium powder, made possible by having the full supply chain in-house – from titanium sponge to finished powder. The new titanium powder process uses advanced electrode induction melting inert gas atomization technology to produce highly consistent and repeatable titanium powder with low oxygen and nitrogen levels. The production facility also includes dedicated downstream sieving, blending and packing facilities – integrated through the use of industrial robotics.

Titanium has exceptional material properties, being strong yet light and offering high levels of corrosion resistance. At the same time, it is biocompatible. However, the cost and complexity of machining from titanium billet have historically restricted its use. Additive manufacturing opens up new opportunities.

Powder metallurgy is also labelled a ‘recognized green technology’ – and the net-shape capability of technologies like additive manufacturing not only means that material waste is minimized, but also that great energy efficiency can be achieved, by eliminating manufacturing steps.

The first two powders produced at the plant will be Osprey Ti-6Al-4V Grade 5 and Osprey Ti-6Al-4V Grade 23. Other alloys are available on request. In addition to the ISO 13485:2016 and AS9100D certifications, the new titanium powder plant is also certified according to ISO 9001, ISO 14001 and ISO 45001.

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