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Proceedings Paper

Safety and essential performance standards for oximeters (Conference Presentation)
Author(s): Sandy Weininger

Paper 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.

Paper Details

Date Published: 26 March 2020
Proc. SPIE 11231, Design and Quality for Biomedical Technologies XIII, 112310M (26 March 2020); doi: 10.1117/12.2555140
Show Author Affiliations
Sandy Weininger, U.S. Food and Drug Administration (United States)

Published in SPIE Proceedings Vol. 11231:
Design and Quality for Biomedical Technologies XIII
Jeeseong Hwang; Gracie Vargas, Editor(s)

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