Standards Testing - Spine
For more than four decades, ORL is recognized as an innovator of testing standards and methods with an extensive track record of providing information necessary for successful regulatory approvals, product quality confirmation, marketing materials and surgeon education. This Standards listing encapsulates the breadth of this expertise.
ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
These test methods provide a basis for the mechanical comparison of spinal implant assemblies and cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model.
ASTM F1798 - Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
This test method provides a means of mechanically characterizing spinal implant interconnections and covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.
ASTM F2077 - Test Methods For Intervertebral Body Fusion Devices
This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies.
ASTM F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.
ASTM F2267 - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices.
ASTM F2346 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs.
ASTM F2423 - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
This guide describes test methods for assessment of the wear and/or functional characteristics of total disc prostheses. Both lumbar and cervical prostheses are addressed.
ASTM F2694 - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
This practice provides guidance for the functional, kinematic and wear testing of motion-preserving total facet prostheses for the lumbar spine.
ASTM F2624 - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
This test method describes means to assess the static, dynamic and wear properties of single level, motion-preserving, spinal constructs.
ASTM F2706 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies.
ASTM F2790 - Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
This practice provides guidance for the static and dynamic testing of lumbar total facet prostheses.
ISO 12189 - Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support
Specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. It is intended to provide a basis for the assessment of intrinsic static and dynamic strength of spinal implants.
ISO 18192-1 - Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
This part defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses. Both lumbar and cervical prostheses are addressed.
ISO 18192-2 - Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements
Defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192‑1.
ISO 18192-3 - Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
Defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.