Sandvik’s new powder plant in Sweden has recently received the ‘ISO 13485:2016’ medical certification for Osprey®titanium powders, now approved for use in the additive manufacturing of medical applications. 3D printing of implants enables rapid manufacturing directly from an individual’s anatomical data – enhancing the healing process and improving the prognosis for the patient.
Sandvik’s titanium powder plant, located in Sandviken Sweden, was inaugurated in the end of 2019, with more than 150 guests including end-users in key industries like aerospace and medical. Since then, extensive work has been ongoing to ramp-up the highly automated plant, fine-tuning the process and optimizing the powder to ensure the best possible consistency, morphology and quality required for additive manufacturing. As a result of this meticulous and structured work, the ’ISO 13485:2016’ certification for medical was recently received in August. Earlier this year, the same powder plant also achieved the prestigious ‘AS9100D’ aerospace certification.
“Getting 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.
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.
“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,” says Keith Murray.
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