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BS ISO 23089-1 ISO 23089-1 Implants for surgery. Pre-clinical mechanical assessment of spinal implants and particular requirements. Part 1: Thoracolumbar pedicle screw systems

Source:
ISO
Committee:
CH/150/5 - Surgical Implants - Osteosynthesis and spinal devices
Categories:
Implants for surgery, prosthetics and orthotics
Comment period start date:
Comment period end date:
Number of comments:
0

Comment by:

Scope

This document specifies the requirements for the mechanical assessment of rigid thoracolumbar pedicle screw systems (TPSSs) used in spinal arthrodesis procedures. Semi-rigid or dynamic TPSSs for arthrodesis or non-fusion procedures can require alternate and/or additional mechanical assessments and are outside the scope of this standard.

This document focuses on mechanical requirements and is not intended to cover all assessments necessary for TPSSs.

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