Standardization News

A proposed ASTM International standard could help manufacturers improve designs for total disc replacements of diseased discs in the spine. The proposed standard (WK33006, Guide for Impingement Testing of Total Disc Prostheses) is being developed by ASTM’s committee on medical and surgical materials and devices (F04).

Specifically, the standard will guide manufacturers through the process of characterizing “impingement behavior” of total disc replacement designs.  Impingement has occurred in many designs due to wear and fatigue, according to analyses of retrieved discs.

“The proposed standard is intended to allow users to evaluate their devices and determine the conditions and parameters that cause impingement,” says ASTM member Ryan Siskey, principal and officer director, Exponent.  “Once selected, users can then run a cyclic test to assess the fatigue and wear performance of components due to repeated impingement duty cycles.”  

According to Siskey, manufacturers and engineers will find the proposed standard useful for assessing next generation device concepts and material combinations. Ultimately, this could improve the longevity and clinical performance of devices.

He also notes that regulators may use the test results to assess safety of new designs. 

While laboratory testing may not always exactly reflect clinical performance, Siskey says, it can be used to compare the performance of the total disc designs.

Members of the spinal community working on total disc replacement are encouraged to join in the development of the proposed standard.

ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting: May 9-11, 2017, May Committee Week, Toronto, Ontario, Canada
Technical Contact: Ryan Siskey, Exponent, Philadelphia, Pa., tel +1.215.594.8800 ext. 8896  
ASTM Staff Contact: Kathleen Chalfin, tel +1.610.832.9717