Sandvik Titanium Powder Plant Achieves ISO 13485 Medical Certification

Sandvik Additive Manufacturing has achieved ISO 13485:2016 medical certification for its titanium powder plant in Sandviken, Sweden. The facility produces Osprey titanium powders which are now approved for use in the additive manufacturing (AM) of medical applications.

“This standard will reassure our customers that Sandvik has the necessary quality management systems in place to meet the stringent requirements of the medical industry,” says Keith Murray, vice president and head of global sales, Sandvik Additive Manufacturing.

Sandvik’s titanium powder plant opened at the end of 2019 with extensive work to ramp up the highly automated plant, finetuning the process and optimizing the powder to ensure the best possible consistency, morphology and quality required for additive manufacturing. Earlier this year, the same plant also achieved the AS9100D aerospace certification. The company says that achieving the ISO 13485:2016 medical certification will allow Sandvik’s medical customers to complete the necessary regulatory supplier approvals when bringing a medical application to market.

The properties of the metal powders 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 is designed to ensure that best practices and continuous improvement techniques – including the company’s development, manufacturing and testing capabilities – are leveraged during all stages of the powder life cycle, resulting in a safer medical device.

Titanium has exceptional material properties, as it is strong yet light and offers high levels of corrosion resistance. It is also biocompatible. However, the cost and complexity of machining from titanium billet have historically restricted its use. Additive manufacturing opens up new opportunities.

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. In addition to the ISO 13485:2016 and AS9100D certifications, the titanium powder plant is also certified according to ISO 9001, ISO 14001 and ISO 45001.