The pulse oximeter is perhaps the first biophotonics-based medical device, and standards have existed for decades to enable characterization of device performance in terms of quantitative metrics, including test methods for clinical validation in human subjects. As cerebral oximetry based on near-infrared spectroscopy has begun to mature, a standard is currently in development to address observed issues with device quality, robustness, and consistency. The availability of standards ensures devices are safe and effective and can improve confidence in their clinical utility. Significant challenges remain in developing clinically relevant test methods.
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