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ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws

This ASTM standard gives methods for testing metallic medical bone screws for their strength and for estimating their performance by inserting them into reference material to simulate real bone.

Test Summary

The standard covers various dimensions for some different types of screws, and details tests to establish the mechanical strength of metallic medical screws. Measuring the torque developed while inserting the screw, and the pullout force are also prescribed.

Test Procedure

Statistically significant quantities of the screws are tested by clamping in a torque testing system. Screws are also driven into reference material to simulate real bone, then subjected to an axial load to determine pullout forces

 

Test Apparatus

A motorised torque testing system together with a force testing stand plus suitable loadcells


Method 

Refer to the standard and the required annexes for details of the test to be performed and apparatus involved. Several tests are given in the standards. Mecmesin can supply test equipment for:
Torsional yield strength
Medical screws are firmly held then subjected to rotational force. By monitoring the torsional load and angle, a torsional yield strength can calculated. (N.B. some manual calculation may be involved)

Maximum torque
The maximum torque is determined from the torque / angle curve.

Breaking angle
The clamped screws are tested to the point of failure, and the angle at which the screw breaks is recorded
Insertion and removal torque
Screws are driven into reference material to simulate real bone. The maximum torque is reported during the initial four revolutions on insertion, and the removal torque on the maximum encountered while reversing the direction.

Pullout strength
Screws are driven into reference material to a specified depth. An axial load is then applied until the screw fails or releases from the test block. The maximum load is reported.

 

Mecmesin Test Equipment Required for BS EN 12209:2003

Force testing equipment
MultiTest force testing stands /computer-controlled-test-systems

Torque testing equipment
Vortex-i computer controlled torque test system: /computer-controlled-torque-test-system

 

Special fixturing to your individual requirements. /customised-force-testing-applications

Please refer to the latest official ASTM test standard for more detailed information. This overview is intended to provide a basic understanding of the test procedure and suitable equipment to meet the standard.


Custom engineering solutions for force & torque measurement


ASTM F543-13 testing medical bone screws

MultiTest twin column force testing stand


ASTM F543-13 testing medical bone screws

Metallic medical bone screws


ASTM F543-13 testing medical bone screws

Vortex-i torque testing system


ASTM F543-13 testing medical bone screws

Bone screws implanted