Sandvik Achieves ISO 13485:2016 Medical Certification for Titanium Powder Plant

Sandvik’s titanium powder plant in Sweden received ISO 13485:2016 certification for medical applications. 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. The new plant is also certified according to ISO 9001, ISO 14001 and ISO 45001.

“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, utilizing Osprey® titanium powders from Sandvik,” says Keith Murray, VP and Head of Global Sales at Sandvik Additive Manufacturing.

Sandvik offers complete traceability for its titanium powder with the full supply chain in-house, from titanium sponge to finished powder. The new titanium powder process uses electrode induction melting inert gas atomization technology to produce consistent and repeatable powder with low oxygen and nitrogen levels. The production facility also includes dedicated downstream sieving, blending and packing facilities, integrated through industrial robotics.

The plant is located next to Sandvik’s additive manufacturing facility in Sandviken, Sweden, including all relevant metal additive manufacturing processes. Sandvik can tailor the powder to different printing processes on the same site.

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