Sandvik, an internationally renowned metal powder manufacturer, obtained the ISO13485:2016 medical certification after obtaining aerospace certification in its titanium powder plant in Sweden. It can already provide titanium powder and other products for medical additive manufacturing applications such as 3D printed implants.
Keith Murray, vice president of Sandvik's AM division and head of global sales, said of this achievement. "Obtaining ISO13485:2016 medical certification will enable our medical customers to use Sandvik's titanium powder to complete the necessary regulatory supplier approvals when they bring medical applications to the market."
There are several reasons why titanium can become a key material in the medical field: Compared with other metals such as stainless steel, it has a superior strength-to-weight ratio; but more importantly, titanium can be physically combined with bones, made of titanium The finished implant can stay in the body for a long time. If combined with the customized advantages of additive manufacturing, this time can be extended.
For the medical industry, the most important thing is that titanium powder needs to have complete traceability. To achieve this, the entire supply chain of Sandvik's titanium powder products is in-house, including advanced electrode induction melting inert gas atomization technology, as well as downstream screening, mixing and packaging facilities.
"Now, we are one of the few metal powder and additive manufacturing companies that have both the aerospace industry AS9100D quality certification and the medical industry ISO13485:2016 certification," Murray said. "This will give us more opportunities to cooperate with customers in the future."