Presentation
26 March 2020 Safety and essential performance standards for oximeters (Conference Presentation)
Sandy Weininger
Author Affiliations +
Abstract
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.
Conference Presentation
© (2020) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Sandy Weininger "Safety and essential performance standards for oximeters (Conference Presentation)", Proc. SPIE 11231, Design and Quality for Biomedical Technologies XIII, 112310M (26 March 2020); https://doi.org/10.1117/12.2555140
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