Hip and Knee Wear Testing - What the Standards Don't Tell You
The current ISO standards for both hip (ISO 14242) and knee (ISO 14243) wear simulation provide well-defined loading and displacement conditions for anatomical joint loading and motion during typical gait.
However, a few areas in the ISO standards lack additional information which makes it a challenge to design and implement a comprehensive pre-clinical wear testing program.
Researchers in the wear testing field have suggestions regarding ambiguous directions in the ISO standard. This white paper offers additional guidance that could help support implant manufacturers in their decision-making and justifications for regulatory submissions.
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