Standardization News

ASTM International’s medical and surgical materials and devices committee (F04) is currently working on a proposed standard on locking mechanisms for locking plate and screw systems. The systems described in the proposed standard (WK88483) aid in the healing of bone fractures. 

The proposed standard will be used to evaluate and compare the mechanical properties of locking mechanisms used with locking plate and screw systems. Test methods include static and fatigue cantilever bend, off-axis cantilever bend, multiple insertion and removal, and maximum stripping torque of the plate/screw interface. 

ASTM member Andy Whitten notes that there are separate standards for plate and screws that test these components individually, but that advancing technology has led to a need for a standard that includes both plates and screws.

“With the advent of locked plating, the plates and screws are combined using a locking mechanism as opposed to the standard compression/friction seating with conventional plating,” says Whitten. “The purpose of the proposed standard is to introduce several test methods that present ways to evaluate the locking mechanism that current standards do not offer.”

Whitten also notes that the proposed standard will cover fixed angle as well as variable angle locking mechanisms to ensure the safety and efficacy of locking plate and screw systems.

ASTM welcomes participation in the development of its standards. JOIN ASTM.