CSA C22.2 No.80601-2-90-2023由SCC 发布于 2023-03-01。
CSA C22.2 No.80601-2-90-2023在国际标准分类中归属于: 11.040.10 麻醉、呼吸和复苏设备。
CSA C22.2 No.80601-2-90-2023 的最新版本是哪一版？
最新版本是 CSA C22.2 No.80601-2-90-2023 。
Scope Replacement: This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: — intended for use with patients who can breathe spontaneously; and — intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: — fully integrated ME equipment; or — a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable.
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