Sandvik has announced its metal 3D printing powder factory in Sweden has received ISO 13485:2016 certification for the manufacture of medical components.
It comes less than a year after the plant was inaugurate and within five months of the same factory receiving AS9100D certification for aerospace supply.
Over the last 12 months, Sandvik has carried out extensive work, and continues to do so, to ramp up the automation, fine-tune the processes and optimise its powder to ensure greater consistency and quality. As a result, the company has managed to secure both the ISO 13485:2016 and AS9100D certifications.
The ISO 13485:2016 certification has been granted after Sandvik demonstrated that best practices and continuous improvement techniques, across development, manufacture and testing, are leveraged during all stages of the powder lifecycle. This should help to ensure that the resulting medical devices additively manufactured with Sandvik powder are consistently safe to use.
“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,” commented Keith Murray, VP and Head of Global Sales at Sandvik Additive Manufacturing. “In additive manufacturing, it is essential to use high-quality metal powders with consistent quality, adapted to the different additive manufacturing processes. Sandvik’s highly automated manufacturing process ensures excellent consistency.
“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. This will facilitate many customer collaborations going forward. Imagine what 158 years of leading materials expertise can do for your additive process.”
So far, Sandvik has been producing Osprey Ti-6AI-4V Grade 5 and Grade 23 powders with other alloys available on request. The facility is also certified according to ISO 9001, ISO 14001 and ISO 45001 standards.