Metal powder manufacturer Sandvik has obtained ISO 13485:2016 medical certification for its titanium powder plant in Sweden. The state-of-the-art facility, which was inaugurated in October 2019, can now supply Osprey titanium powders for medical additive manufacturing applications, like 3D printed implants.
Keith Murray, Vice President and Head of Global Sales at Sandvik’s AM division, said of the accomplishment: “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.”
Titanium is a critical material in the medical sector for several reasons. For one, its strength-to-weight ratio is superior compared to other metals like stainless steel. But more crucially, titanium can physically bond with bone and implants made from titanium last a long time in the body. If you throw additive manufacturing into the mix, titanium implants can be taken to the next level, through patient-specific customization.
Sanvik’s powder production facility not only has the equipment to produce high quality powders, it also offers complete traceability for its titanium powders, which is important in the medical industry. This is enabled in large part because the full supply chain for titanium powders is in-house, including advanced electrode induction melting inert gas atomization technology, as well as downstream sieving, blending and packing facilities.
In addition to being qualified to produce titanium powders for medical AM applications, Sanvik’s facility also recently obtained AS9100D certification for the aerospace industry. “Now we are one of few metal powder and additive manufacturing companies that holds both the AS9100D quality certification for aerospace and the ISO 13485:2016 certification for medical,” said Murray. “This will facilitate many customer collaborations going forward. Imagine what 158 years of leading materials expertise can do for your additive process.”
The Swedish plant, located next to Sandvik’s AM facility in Sandviken, produces high quality titanium powders for AM, including Osprey Ti-6Al-4V Grade 5 and Osprey Ti-6Al-4V Grade 23. (Sandvik also develops custom alloys on request.) The facility also includes a sieving tower for nickel-based superalloys.
“Sandvik’s launch of titanium powders for additive manufacturing supports a growing trend towards the 3D printing of titanium parts,” said Mikael Schuisky, Head of R&D and Operations at the Additive Manufacturing division in Sandvik, at the powder plant’s inauguration. “The additive process results in far less material waste than traditional subtractive techniques, while also encouraging new levels of design freedom. This is opening up the use of titanium in other industries, such as automotive and tooling.”