Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Methods for compression bending, tensile bending, torsion testing, and compressive bending fatigue testing of vertebrectomy models, as well as guidelines for measuring displacement, determining yield load, and evaluating the stiffness and strength of spinal implant components.

Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Test methods for evaluating the uniaxial static strength, fatigue strength, and resistance to loosening of spinal arthrodesis implant interconnection mechanisms. Mechanical static testing is performed until failure and fatigue testing of components is performed. Loads are applied to the interconnect in the relevant direction, as described in the ASTM standard.

Standard Test Methods for Intervertebral Body Fusion Devices

Static and fatigue testing of intervertebral body fusion devices in the axial, transverse, and compressive shear directions to characterize the structural integrity of the device. The samples were tested between simulated vertebral bodies made of polyacetal blocks for dynamic loading and stainless steel blocks for static loading. The blocks are designed to match the geometry of the device, similar to how the device fits into the vertebral endplates. Samples are tested for 5 million cycles, or until failure.

Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

​Axial compression testing of intervertebral devices in two polyurethane foam blocks simulating bone matrix is ​​described. The blocks are designed to match the geometry of the device, similar to how the device fits into the vertebral endplates. Apply an axial load and record the displacement of the sample.

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Static and fatigue testing of occipital-cervical and occipital-cervical-thoracic implant components in a vertebrectomy model are described. Static load testing is performed using three different tests, including compression bending, tensile bending, and torsion testing. Fatigue tests include compression bending fatigue and torsion fatigue. Tested to 5 million cycles, or until failure.

Standard Test Methods for Sacroiliac Joint Fusion Devices

Static and fatigue testing of linear and transverse sacroiliac joint (SIJ) fusion implants are described. The online SIJ fusion implant testing method characterizes mechanical properties under shear and torsion by testing between simulated vertebral bodies made of polyacetal blocks for dynamic loading and stainless steel blocks for static loading. The transverse SIJ implant test method evaluates the torsional strength, flexural strength, and pullout resistance of implants inserted into grade 20 polyurethane foam. Fatigue components are tested for 2.5 million cycles, or until failure.

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

This standard defines specifications for metallic spinal screws, spinal plates, and spinal rods, as well as static and fatigue bending strength test methods. Static and fatigue testing is intended to mechanically characterize a device design, not to define performance or predict the consequences of use.

Fatigue test method for spinal implant assemblies using an anterior support

Anterior spinal implant constructs were subjected to fatigue compression testing to evaluate implant components. Use UHMWPE blocks to simulate vertebrae. Testing was stopped after 5 million cycles or structural failure of the spinal implant.

Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements

Requirements for the connector portion of the implantable lead and the mating connector cavity for connection to the implantable pulse generator.