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