GUIDELINES FOR SPO2 MEASUREMENT USING THE MAXIM® MAX32664 SENSOR HUB The SpO2 measurement performance of a device must be verified before the device is release

GUIDELINES FOR SPO2 MEASUREMENT USING THE MAXIM® MAX32664 SENSOR HUB The SpO2 measurement performance of a device must be verified before the device is released to the market. The U.S. Food and Drug Administration (FDA) suggests using standards presented in the following: ISO 80601-2-61:2017 – Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Pulse Oximeters – Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff According to these regulations, manufacturers need to declare the calibration range, reference, accuracy, methods of calibration and range of displayed saturation level. Furthermore, for the performance assessment, the FDA requires at least 200 data points equally spaced over a saturation range of 70% to 100%. Test subjects should have different ages, gender, and skin tones. For instance, the FDA requires that at least 30% of the volunteers must have dark skin pigmentation. The overall error or the root mean square error (RMSE) must be below 3.0% for transmissive pulse oximetry and below 3.5% for reflective pulse oximetry. © 26 Mar, 2019, Maxim Integrated Products, Inc. https://www.maximintegrated.com/en/design/technical-documents/app-notes/6/6845.html https://www.maximintegrated.com/en/design/technical-document...