The international standard ISO 80601-2-90:2021 specifies basic safety and essential performance requirements, including risks associated with oxygen, flow accuracy, oxygen concentration accuracy, humidification output performance, and corresponding test methods for high-flow respiratory therapy equipment. This study focuses on the key points in ISO 80601-2-90:2021 and the key problems in the test evaluation. This study also briefly introduces the relationship between ISO 80601-2-90:2021 and other standards, and explains the countermeasures that stakeholders should take.
Keywords: essential performance; high flow rate; respiratory therapy; standards; test evaluation.