Pulse Oximetry FAQ

This FAQ has been compiled by our team of experts. Please submit your questions at the bottom of this page!

Pulse Oximetry FAQ

Pulse ox validation & certification

Pulse ox validation & certification

Can pulse oximeter performance be validated by an in vitro device?

Do pulse oximeters require regular calibrations while in clinical use?

How accurate are pulse oximeters?

How is pulse oximeter clinical validation done for FDA 510k clearance and ISO CE marking?

How is skin color measured for the purposes of oximeter performance validation?

Is it true that oximeters are not reliable below 70% SpO2?

What does the CE marking mean?

What does the IP rating mean?

What is ISO and what standards exist for pulse oximeters?

What is the meaning of ‘substantially equivalent’ for FDA approval?

What is the root mean square error or deviation?

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About Community Device Data Raw Data Protocols Publications Oximetry FAQ

Healthy Human Performance Tests

To meet ISO standards (80601-2-61) or FDA guideline adherence for clinical use, pulse oximeter performance must be tested in healthy humans in a laboratory setting. Independent device testing for the Open Oximetry Project follows our protocol consistent with ISO and FDA. Only devices labeled as ‘verified’ or ‘disputed’ have been independently tested by the Open Oximetry Project.
All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry Team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:

No Data

No Data

1 (red)

>4%

2 (red)

<4%

AND/OR Data suggesting Arms for dark skin color of >4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%

3 (yellow)

<4%

AND/OR Data suggesting Arms for dark skin color of 3-4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%

4 (green)

<3%

AND No data for or against performance problems in darker skin colors

AND No data for or against performance problems in low perfusion

5 (green)

<3%

AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023

AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023

* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark) get labeled as ‘verified’