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

What is ISO and what standards exist for pulse oximeters?

The International Organization for Standardization (ISO) is a worldwide standard-setting body. It is composed of representatives from several national standards organizations and aims to provide common standards for technology, agriculture, healthcare, and other manufactured products. These standards are meant to ensure that products and services are safe and of good quality.

ISO has standards for various healthcare-related devices and products, including pulse oximeters. ISO 80601-2-61:2017 describes the requirements for basic safety and essential performance of pulse oximeter equipment. This also includes standards for the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.

References: ISO: Pulse Oximeter

Keywords: ISO, international organization for standardization

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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’