Standardization News

Although regulatory bodies, including the U.S. Food and Drug Administration, frequently request information from manufacturers on the potential for ion release from surgical implants containing metal, there has not been a standard method for performing this evaluation. However, a proposed new ASTM standard, WK47808, Test Method for Ion Release Evaluation of Medical Implants, will provide such a test.

An FDA document published in August 2013 requires that ion release tests for intravascular stents and associated delivery systems last up to 60 days, including capturing a potential initial burst, and showing the release as a function of time.

"The proposed standard is intended to guide a user on how to practically perform this test in a laboratory," says ASTM member Dr. Matthias Frotscher, manager of stent testing, Cortronik. "The standard will provide a test method to determine if a medical device is safe regarding the release of metal ions into a human body."

Materials and products that would be covered by WK47808 include endovascular devices, such as stents and heart valves, and potentially orthopedic devices and other single-use implantable medical devices. Manufacturers, regulators, consumers and laboratories will all benefit

from the test, once the standard has been approved.

WK47808 is being developed by Subcommittee F04.15 on Material Test Methods, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices. Representatives of manufacturers, laboratories and regulatory bodies, as well as other interested technical experts, are encouraged to join in the development of WK47808. A collaboration area will be set up on the ASTM website for this purpose.

CONTACT Technical Information: Matthias Frotscher, Cortronik • Rostock-Warnemuende, Germany • tel +49.381.8173.7251 | ASTM Staff: Pat Picariello • tel +1.610.832.9720 | Upcoming Meeting: May 19-22 • May Committee Week • Anaheim, Calif.