BS ISO 12189:2008

BS ISO 12189:2008 Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support

BS ISO 12189 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.

Contents of BS ISO 12189:

• Foreword
• Introduction
• Scope
• Normative references
• Terms and definitions
• Principle
• Reagents and materials
• Fluid test medium (optional)
• Test specimen
• Apparatus
• Testing machine
• Means of mounting and enclosing the test specimen
• Temperature control system (optional)
• Procedure
• Test report
• Accuracy and bias
• Accuracy
• Bias
• Bibliography