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  1. Zwick
22 January 2018

Testing of Spinal Implants

Pulsating compressive strength tests (R=0.1) are performed on six specimens with a test frequency of up to 5Hz. Result: Generation of a Wöhler curve with a number of cycles to crack up to 5 million.

This corresponds to approximately two years in-vivo, with approximately 7,000 cycles per day. The first runout is confirmed.

In addition to purely axial tensile, compression and flexure tests, a pure or combined torsion load can be applied to spinal systems in compliance with standards including ASTM F1717-9, ASTM F2706-8 or ISO 12189-08.

These tests can be performed under physiological (in-vivo) conditions (for example, tempered saline solution) using a Zwick thermoregulation bath:

  • ASTM F1717-9 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F2706-8 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
  • ISO 12189-8 Implants for surgery – Mechanical testing of implantable spinal devices, Fatigue test method for spinal implant assemblies using an anterior support

For practical statistical evaluations of fatigue tests in the finite life range (high-cycle fatigue) and in the transitional range to fatigue strength (long-life fatigue), Zwick offers the technical-scientific programme Statistical Analysis of Fatigue Data (SAFD).

This brochure provides an overview of instruments, machines, systems, and services available from Zwick Roell for testing products from the medical technology and pharmaceutical industries,...
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