What is ISO 23089-2 about?
ISO 23089-2 is one of a series of documents for implants for surgery that outlines requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures.
ISO 23089-2 focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.
IBFDs function as load-bearing implants that are subjected to the mechanical loads associated with the region of the spine in which the device is implanted. IBDF mechanical assessments shall consider the device’s performance under the following loading modes axial compression, compression-shear, and Torsion
In situations where the evaluation of an IBFD under the loading modes prescribed in this clause is deemed unnecessary, the user of ISO 23089-2 choosing not to carry out the evaluation shall provide justification for this decision.
Who is ISO 23089-2 for?
ISO 23089-2 on implants for surgery is useful for-
- Manufacturers of spinal intervertebral body fusion devices
- Medical laboratories
- Healthcare facilities
Why should you use ISO 23089-2?
Spinal intervertebral body fusion devices (IBFDs) are used in the treatment of various spinal pathologies. IBFDs are intended to be placed in between two adjacent vertebral bodies after removal of the interverbal disc to maintain the disc height and provide mechanical stability to the spine until fusion (arthrodesis) occurs.
ISO 23089-2 intends to establish a minimum battery of performance testing necessary during the development of IBFDs. And helps in setting high-quality standards relating to coating characterization, migration/expulsion, corrosion, and impaction for spinal intervertebral body fusion devices that ensure the health and safety of patient’s life.
