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

Causes of inaccuracies

Causes of inaccuracies

Are low cost oximeters less accurate?

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

Do tattoos impact pulse oximeter accuracy?

Does anemia interfere with pulse oximeter accuracy?

Does body temperature affect pulse oximeter accuracy?

Does henna impact pulse oximeter accuracy?

Does low perfusion impact pulse oximeter accuracy?

Does motion interfere with pulse oximeter accuracy?

Does nail polish impact pulse oximeter accuracy?

Does skin pigment impact pulse oximeter accuracy?

What are common reasons for inaccurate pulse oximeters readings?

What does a normal pulse oximeter photoplethysmograph look like?

Where on the body can pulse oximeters be used to measure SpO2?

You have additional questions?

Submit a question

About Community Device Data Raw Data Protocols Infographic Builder Publications Diversity Toolkit Skin Color Quantification FAQ

Healthy Human Performance Tests

To meet 2017 ISO standards (80601-2-61) or 2013 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 ‘failed’ 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 Lab) get labeled as ‘verified’