New ASTM International standard, F3306, aims to help determine the safety of surgical implants and prevent potentially adverse effects on patients.
The new test method assesses metal and other ions released from single-use, metallic, implantable medical devices and the components of such devices. The test involves putting the devices and components in a container with solutions that simulate the in-vivo environment and temperature. Samples are then taken at intervals.
Matthias Frotscher, senior manager of stent and material testing at Biotronik, said the broad scope of F3306 covers a wide range of medical devices, including endovascular devices and orthopedic implants dentistry-related items.
“This standard will ensure that the medical device industry and notified bodies now have a standardized and widely-accepted test method available for evaluation and comparison,” Frotscher said.
Implant manufacturers, regulatory agencies, consumers, and laboratories could all benefit from the new standard.
F3306 was developed by ASTM’s committee on medical and surgical materials and devices (F04). Once users have gained experience with the new standard, F04 plans to launch an interlaboratory study to further refine the standard with a precision-and-bias statement.