DANSK DS/ISO 12189 PDF

The standard specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. The purpose of this proposal is to complete the document entitled "Mechanical testing of implantable spinal devices", intended to provide a basis for the assessment of intrinsic static and dynamic strength of spinal implants. This document strongly emphasizes the effects of the load sharing phenomenon, largely described in the literature, as a very important feature regarding the load patterns to which the spinal implants are submitted. Some kinds of implants are often too flexible to be tested on their own or in a corpectomy configuration. For devices which are able to withstand loading in a corpectomy configuration, the test should be performed without anterior support in accordance with ASTM F1717 to demonstrate a worst-case scenario that the device can support full load. In addition, this standard is intended to allow fatigue testing of flexible spinal implants and allow comparable biomechanical fatigue testing of any kind of spinal implants, regardless of their intrinsic rigidity. This document describes compression/flexion fatigue testing; additional mechanical tests such as multi-directional testing (shear, torsion, lateral bending) may be required to assess clinical device safety.