PI-68 Standard Test Method for Metallic Bone Plates Used for Fixation of Minor Bone Fractures

The standard “PI-68 Standard test method for metallic bone plates used in fixation of minor bone fractures” developed by PI Medical Implants describes a procedure for testing minor bone metallic plates.

Small bone plates are primarily used for fracture fixation in the distal extremities of the body, such as the fingers and toes, and in the craniomaxillofacial region. Other standards referenced for metallic bone plates include:

• ASTM F382-99 Standard specification and test method for metallic bone plates
• ISO 9585 Implants for surgery – Determination of flexural strength and stiffness of bone plates

However, due to the smaller size of the plates used in small bone fracture fixation, some of the test methods described in these standards are quite difficult to set up and execute.

The PI-68 standard provides static and dynamic test methods, specifying the types of loads and the specific methods of applying these loads. To evaluate and characterize them, the following tests are mainly performed:

• Static and dynamic torsion testing
• Static and dynamic cantilever beam bending test
• Static and dynamic lateral bending test
• Static and dynamic three-point bending test

Essentially, bone plates provide a framework to which the broken bone can be attached, facilitating the anatomical reduction of the bony column in some cases and, if the implant is correctly selected and applied, neutralizing the forces acting on the broken bone during the healing process.

Bone plates can differ in four basic ways:

• Composition: Most bone plates are made of 316L stainless steel. Titanium implants are somewhat softer than stainless steel and less effective against tissue, but are significantly more costly and therefore have limited use in orthopedics.
• Size: The size of a bone plate depends on its length and thickness and the size of screw that can be placed in its holes.
• Design: T-plates, L-plates, semicircular or acetabular plates, and TPLO plates are modifications to the standard flat plate. They allow the implant to be shaped to a specific area of ​​bone and allow more screws to be placed in a limited space than would be possible with a flat plate.

• Application: Two bone plates may look the same, but they can be used in very different ways. No long bone is a perfect cylinder aligned exactly parallel to the weight-bearing forces applied to it. As a result, one side of the bone is in tension from these weight-bearing forces, while the other side is often under the influence of distracting forces. The three basic features of screw design are size, thread characteristics, and the way the threads are drilled into the bone.

Bone plates and screws are rarely removed after fracture healing is complete. In general, bone plates are removed only if they are causing a problem, such as if there is infection or if limping, swelling, or irritation continues over a plate after clinical healing.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, it also provides testing services defined in the standard “PI-68 Standard test method for metallic bone plates used in the detection of minor bone fractures” with its trained and expert staff and advanced technological equipment.