高流量呼吸治疗设备国际标准ISO 80601-2-90:2021解析

Analysis of International Standard ISO 80601-2-90:2021 for High-flow Respiratory Therapy Equipment

摘要: 高流量呼吸治疗设备专用标准ISO 80601-2-90:2021规定了高流量呼吸治疗设备的基本安全和基本性能要求，包括与氧气有关的风险、流量精度、氧气浓度精度、湿化输出性能等要求以及相应试验方法。重点阐述了ISO 80601-2-90:2021标准中的关键要点及试验评价中的关键问题。简要介绍了ISO 80601-2-90:2021标准与其他标准的关系，说明了利益相关方应采取的应对措施。

Abstract: 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.